Latest news with #PROTECT
News.com.au
01-05-2025
- Business
- News.com.au
ASX Health Quarterly Wrap: Island completes Phase 2a/b dengue trial
Special Report: It's been a tricky few months for the ASX health sector, weighed down by global geopolitical tensions, economic uncertainty and concerns over potential policy shifts under a second Donald Trump US presidency. Investor jitters have grown amid staffing upheaval at the US Food and Drug Administration (FDA), where reported mass layoffs under Elon Musk's Department of Government Efficiency (DOGE) were swiftly followed by a partial rehiring, raising then easing concerns about the regulator's ability to manage clinical trials and drug approvals. Against the uncertain backdrop, Stockhead's healthcare clients have been showing signs of resilience reporting business as usual in their latest quarterly reports. Island Pharmaceuticals (ASX:ILA) During Q3 FY25 Island completed its Phase 2a/b PROTECT trial of ISLA-101 in dengue fever with top-line results from both cohorts forecast to be reported in May. Island completed Phase 2b enrolment and dosing on schedule and with no delays in February after announcing in November the trial's safety review committee (SRC) deemed ISLA-101 safe and exhibiting evidence of anti-dengue activity. Pharmacokinetic data for 2b cohort was received post quarter-end with target blood level concentration achieved in all participants. During the quarter Island continued to advance pipeline expansion opportunities, with particular focus on the opportunity to acquire Galidesivir from Nasdaq-listed BioCryst Pharmaceuticals. Galidesivir is an antiviral with a broad spectrum of activity across more than 20 RNA viruses, including high-priority threats such as Ebola, Marburg, MERS, Zika, yellow fever, and SARS-CoV-2. The company raised $1.94 million during Q3 FY25 via the exercise of more than 32 million options, which expired in March. The options were issued to shareholders who took part in Island's fully underwritten rights issue in March 2024, which raised ~$1.94m. Island carried out several shareholder engagement and promotional activities during the quarter, highlighted by presentations at two major investor conferences and a series of meetings with Australian investors. Net cash used in operating activities totalled $874,000 for Q3 FY25, primarily related to R&D associated with its Phase 2a/b PROTECT trial, as well as administration and corporate costs. Island ended the quarter with $4.82m in cash. "Q3 FY25 marked a period of considerable progress, underscored by key developments for the Phase 2b cohort of our PROTECT trial, which has the potential to highlight ISLA-101's utility as a treatment for dengue fever," CEO and managing director David Foster said. Tryptamine said it made advancements in the clinical development pathway its novel IV-infused psilocin formulation TRP-8803 during the March quarter. The company inked a clinical trial research agreement with Swinburne University to start what it describes as a "world-first" open-label trial to assess the safety, feasibility and efficacy of TRP-8803, when administered together with psychotherapy for adult patients with binge eating disorder (BED). The trial will recruit 12 patients, in two six-person cohorts, with participants to be administered two doses of TRP- 8803 two weeks apart. In January CEO and managing director Jason Carroll presented Biotech Showcase in San Francisco. The conference provides private and micro-mid-cap biotechnology companies with the opportunity to present and connect with investors, industry participants and executives. BDO Audit Pty Ltd was appointed as auditor in January, following resignation of William Buck Audit (VIC) Pty Ltd. Tryptamine has also appointed Hamish George as company secretary, following the resignation of David Franks. Tryptamine held $4.58m in cash at the end of the quarter with an expected ATO R&D tax refund of ~$900,000 to $1m. "The work undertaken during the last quarter has laid a very strong foundation for the coming months, allowing the Company rapidly advance its clinical development pathway for TRP-8803," Carroll said. Dimerix (ASX:DXB) During the March quarter Dimerix continued to progress its ACTION3 phase III trial of lead drug candidate DMX-200 in focal segmental glomerulosclerosis (FSGS), including holding a positive Type C meeting with the FDA in March 2025. The meeting confirmed the acceptability of proteinuria as an appropriate endpoint for full marketing approval in the US. The company said 183 patients have currently been randomised/dosed in the ACTION3 trial with the first paediatric patient recruited. During the quarter Dimerix entered in exclusive licence deal with Fuso Pharmaceutical Industries to develop and commercialise DMX-200 in Japan to treat FSGS. It is the third licensing agreement that Dimerix has successfully executed for DMX-200 in FSGS with the company saying it continued to receive strong partnering interest. In other highlights for the quarter Dimerix was admitted to the S&P/ASX All Ordinaries index and presented at several key conferences. The company had net operating cash outflows for the quarter of $4.3m. It ended the quarter with $17m cash. Dimerix said this does not include the anticipated $4.1m first milestone payment from its Fuso licensing agreement anticipated in the second quarter of 2025 or up to $6.3m from the exercise of outstanding options expiring in June. Post quarter the company today announced it had inked an exclusive licensing deal with Nasdaq-listed Amicus Therapeutics to commercialise its phase III drug candidate DMX-200 in the US. Optiscan (ASX:OIL) Optiscan said a highlight of the quarter was the unveiling in February of InForm, its next generation microscopic medical imaging device specifically for pathology laboratory workflows which marks a significant milestone in technological advancements for the company. InForm is a first-in-class microscopic medical imaging device specifically designed to transform pathology by delivering real-time digital insights across the full workflow from the very point of contact with a tissue sample. The company completed beta-phase work on its cloud-based Telepathology platform with feedback from potential users gathered. Optiscan said the insights were analysed and addressed, leading to implementation of various enhancements with the company on track to deliver the final minimum viable product for its Telepathology platform in Q4 FY25. The company has also significantly progressed plans to enter the veterinary market. Development of a dedicated veterinary product continues with a prototype device also set to be unveiled this quarter. As planning for a trial at Royal Melbourne Hospital started during the quarter, Optiscan said more InVue systems were being manufactured. Patient recruitment is anticipated to begin in Q4 FY25, with early-stage data to shape protocols for expanded clinical trials planned for the US in FY26, pending US FDA approvals. During the quarter Optiscan's regulatory team worked closely with expert consultants in strategising the best regulatory path forward for its InVue and Inform devices. New key executive appointments were made also made during the quarter to implement Optiscan's transformation plan that is strategically focussed on clinical, regulatory and commercial outcomes. The company has also undertaken significant enhancements to its Melbourne facilities in preparation for increased demand on its manufacturing and assembly capabilities and extensive R&D work During the quarter Optiscan received a $1.775m R&D tax refund, which was $1m more than in previous years, due to its successful Advance and Overseas Finding application.
Cision Canada
29-04-2025
- Business
- Cision Canada
CSL Vifor and Travere Therapeutics announce standard EU approval for FILSPARI® in IgA Nephropathy
European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN) Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025 EU approval is based on the complete data set from the phase-III PROTECT study ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /CNW/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. "The decision by the European Commission is an important advancement for people living with IgAN in the EU", said Dr. Vinicius Gomes De Lima, Head of Global Medical Affairs at CSL Vifor. "The standard approval, granted without changes to the indication, underscores the value of our clinical data, the dedication of our teams, and our ongoing commitment to deliver on our promise for patients. We look forward to continuing working closely with healthcare professionals, patient communities, and regulatory bodies to ensure access to FILSPARI across Europe." The European Commission's standard approval of FILSPARI is a meaningful step forward for people living with IgA nephropathy across Europe," said Dr. Jula Inrig, Chief Medical Officer at Travere Therapeutics. "This decision not only validates the strength of the phase-III PROTECT study results but also reinforces our deep commitment to this rare kidney disease community. We remain dedicated to working with our partners, regulators, and healthcare providers to expand access and improve outcomes for those affected by IgAN." The European Commission's decision follows CHMP's recommendation to convert the CMA to standard MA from February 2025. The approval is based on a comprehensive clinical data set, including positive confirmatory results from the pivotal phase-III PROTECT study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan. FILSPARI is the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA), a non-immunosuppressive therapy for the treatment of IgAN approved in Europe and is currently available in Germany, Austria and Switzerland, following the European Commission's conditional marketing authorization in April 2024 About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, About Travere Therapeutics At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow. For more information, visit About IgA Nephropathy (IgAN) IgAN, also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure. While rare, IgAN is the most common type of primary glomerular disease worldwide and a leading cause of kidney failure. IgAN is estimated to affect up to 250,000 people in the licensed territories (Europe, Australia and New Zealand). About the PROTECT study The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only head-to-head vs. comparator trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of sparsentan, compared to 300 mg of irbesartan (an angiotensin II receptor blocker(ARB)), in 404 patients ages 18 years and up with IgA nephropathy and persistent proteinuria despite receiving at least 50% of maximum label dose and maximally tolerated angiotensin-converting enzyme (ACE) inhibitors or ARB therapy. The PROTECT study met its primary endpoint at the pre-specified interim analysis with statistical significance. After 36 weeks of treatment, patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of 49.8 percent, compared to a mean reduction in proteinuria from baseline of 15.1 percent for irbesartan-treated patients. The two-year confirmatory results from the study showed treatment with FILSPARI achieved statistical significance on the eGFR chronic slope endpoint versus irbesartan and demonstrated clinically meaningful kidney function preservation. eGFR is a blood test that measure how well kidneys filter waste products from blood. Treatment emergent adverse events were well-balanced between sparsentan and irbesartan, except for dizziness and hypotension. About FILSPARI (sparsentan) FILSPARI is an innovative, non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist with high selectivity for the endothelin A receptor (ETAR) and the angiotensin II subtype 1 receptor (AT1R). FILSPARI was developed by Travere Therapeutics and has been granted Orphan Drug Designation for the treatment of IgA nephropathy in the UK, Europe and the U.S. FILSPARI is currently available in the U.S. and first markets in Europe. CSL Vifor has been granted exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand. For more information, please refer to the Summary of Product Characteristics (SmPC). CSL Vifor Media Contact Travere Therapeutics: Investors 888-969-7879 [email protected] Media 888-969-7879 [email protected] SOURCE Vifor International AG (CSL Vifor)
Malaysian Reserve
29-04-2025
- Business
- Malaysian Reserve
RedHill Biopharma Secures Allowance of Key Chinese Patent Application for Proprietary COVID-19 Treatment, RHB-107
Strong Use of Composition-of-Matter Coverage: Patent protects the molecular structure of RHB-107, providing market exclusivity beyond method-of-use claims COVID-19 Therapeutic Use: Includes coverage for treatment of SARS-CoV-2, including wild-type and emerging variants This patent grant enhances RedHill's strategic positioning in the global COVID-19 therapeutic space, a market still expected to be worth more than $3 billion in 2025[1], and expands its patent footprint in Asia, a key pharmaceutical market RHB-107 successfully met the primary endpoint of safety and tolerability, delivering promising reduction in hospitalization efficacy results in a U.S. Phase 2 COVID-19 study[2]. Additional clinical data expected from the externally non-dilutive funded PROTECT study, supported by the U.S. Department of Defense RHB-107 is a novel, patient-friendly oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations[3] RALEIGH, N.C. and TEL-AVIV, Israel, April 28, 2025 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) ('RedHill' or the 'Company'), a specialty biopharmaceutical company, today announced that the China National Intellectual Property Administration ('CNIPA') has formally allowed a critical use of composition-of-matter patent for RedHill's proprietary investigational compound RHB-107 (upamostat), a potential oral treatment for COVID-19 (patent application No. 202311591091.6). 'This newly allowed Chinese patent application is a significant success, enhancing RedHill's strategic positioning in the global COVID-19 therapeutic space – a market still expected to be worth more than three billion dollars in 2025. It provides broad and robust protection of the use of RHB-107, including its structure in oral formulations targeting SARS-CoV-2 infections, including both wild-type and naturally occurring variants and expanding its patent footprint in Asia, a key pharmaceutical market,' said Guy Goldberg, RedHill's Chief Business Officer. 'It underscores the uniqueness of our antiviral candidate and further strengthens our global intellectual property portfolio as we advance development of a much-needed oral candidate for early, community-based (non-hospitalized) treatment of COVID-19, which still represents a considerable threat to vulnerable patients. As a novel, potentially broad-acting, host-directed antiviral that is expected to act independently of viral spike protein mutations, RHB-107, if approved, could provide a much-needed additional option for use in the early COVID-19 treatment space, alongside Pfizer's Paxlovid.' Data from RHB-107's U.S. Phase 2 study, published in the International Journal of Infectious Diseases, showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized for COVID-19 on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with new severe COVID-19 symptoms reported by only 2.4% of the RHB-107 treated group (1/41) compared to 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036). Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with RHB-107 compared to 8 days with placebo. Additional clinical data is expected from the externally non-dilutive funded PROTECT study, supported by the U.S. Department of Defense. About RHB-107 (upamostat) RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; in the initial COVID-19 study, among 41 patients only one reported a drug-related adverse reaction (a mild, self-limited, rash). In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients[4]. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharma AG (FSE: HPHA) (formerly WILEX AG) for all indications. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], with submission planned for marketing authorization in other territories. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. Government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS), a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204, an all-in-one, fixed-dose, orally administered, combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at: / Forward Looking Statement This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words 'intends,' 'may,' 'will,' 'plans,' 'expects,' 'anticipates,' 'projects,' 'predicts,' 'estimates,' 'aims,' 'believes,' 'hopes,' 'potential' or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that the CNIPA does not grant the patent in a timely manner or at all; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Category: R&D [1] A randomized, placebo-controlled pilot study of upamostat, a host-directed serine protease inhibitor, for outpatient treatment of COVID-19 Plasse, Terry F et al. International Journal of Infectious Diseases, Volume 128, 148 – 156.[3] Preliminary data from a recent in vitro study.[4] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112adi@ Logo: View original content:
Yahoo
28-04-2025
- Business
- Yahoo
RedHill Biopharma Secures Allowance of Key Chinese Patent Application for Proprietary COVID-19 Treatment, RHB-107
Strong Use of Composition-of-Matter Coverage: Patent protects the molecular structure of RHB-107, providing market exclusivity beyond method-of-use claims COVID-19 Therapeutic Use: Includes coverage for treatment of SARS-CoV-2, including wild-type and emerging variants This patent grant enhances RedHill's strategic positioning in the global COVID-19 therapeutic space, a market still expected to be worth more than $3 billion in 2025[1], and expands its patent footprint in Asia, a key pharmaceutical market RHB-107 successfully met the primary endpoint of safety and tolerability, delivering promising reduction in hospitalization efficacy results in a U.S. Phase 2 COVID-19 study[2]. Additional clinical data expected from the externally non-dilutive funded PROTECT study, supported by the U.S. Department of Defense RHB-107 is a novel, patient-friendly oral, once-daily, host-directed potential broad-acting antiviral expected to act independently of viral spike protein mutations[3] RALEIGH, N.C. and TEL-AVIV, Israel, April 28, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the China National Intellectual Property Administration ("CNIPA") has formally allowed a critical use of composition-of-matter patent for RedHill's proprietary investigational compound RHB-107 (upamostat), a potential oral treatment for COVID-19 (patent application No. 202311591091.6). "This newly allowed Chinese patent application is a significant success, enhancing RedHill's strategic positioning in the global COVID-19 therapeutic space – a market still expected to be worth more than three billion dollars in 2025. It provides broad and robust protection of the use of RHB-107, including its structure in oral formulations targeting SARS-CoV-2 infections, including both wild-type and naturally occurring variants and expanding its patent footprint in Asia, a key pharmaceutical market," said Guy Goldberg, RedHill's Chief Business Officer. "It underscores the uniqueness of our antiviral candidate and further strengthens our global intellectual property portfolio as we advance development of a much-needed oral candidate for early, community-based (non-hospitalized) treatment of COVID-19, which still represents a considerable threat to vulnerable patients. As a novel, potentially broad-acting, host-directed antiviral that is expected to act independently of viral spike protein mutations, RHB-107, if approved, could provide a much-needed additional option for use in the early COVID-19 treatment space, alongside Pfizer's Paxlovid." Data from RHB-107's U.S. Phase 2 study, published in the International Journal of Infectious Diseases, showed a 100% reduction in hospitalization due to COVID-19, with zero patients (0/41) on the RHB-107 arms versus 15% (3/20) hospitalized for COVID-19 on the placebo-controlled arm (nominal p-value=0.0317). The study also showed an approximately 88% reduction in reported new severe COVID-19 symptoms after treatment initiation, with new severe COVID-19 symptoms reported by only 2.4% of the RHB-107 treated group (1/41) compared to 20% (4/20) of patients in the placebo-controlled arm (nominal p-value=0.036). Further post-hoc analysis showed faster recovery periods from severe COVID-19 symptoms with a median of 3 days to recovery with RHB-107 compared to 8 days with placebo. Additional clinical data is expected from the externally non-dilutive funded PROTECT study, supported by the U.S. Department of Defense. About RHB-107 (upamostat) RHB-107 is a proprietary, first-in-class, once-daily orally administered investigational antiviral, that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated; in the initial COVID-19 study, among 41 patients only one reported a drug-related adverse reaction (a mild, self-limited, rash). In addition, RHB-107 inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. RHB-107 has undergone several Phase 1 studies and two Phase 2 studies, demonstrating its clinical safety profile in approximately 200 patients[4]. RedHill acquired the exclusive worldwide rights to RHB-107, excluding China, Hong Kong, Taiwan and Macao, from Germany's Heidelberg Pharma AG (FSE: HPHA) (formerly WILEX AG) for all indications. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults[5], with submission planned for marketing authorization in other territories. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. Government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS), a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204, an all-in-one, fixed-dose, orally administered, combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at: / Forward Looking Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that the CNIPA does not grant the patent in a timely manner or at all; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Category: R&D [1] A randomized, placebo-controlled pilot study of upamostat, a host-directed serine protease inhibitor, for outpatient treatment of COVID-19 Plasse, Terry F et al. International Journal of Infectious Diseases, Volume 128, 148 – 156.[3] Preliminary data from a recent in vitro study.[4] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: Company contact:Adi FrishChief Corporate & Business Development OfficerRedHill Biopharma+972-54-6543-112adi@ Logo: View original content: SOURCE RedHill Biopharma Ltd. Sign in to access your portfolio
The Australian
23-04-2025
- Health
- The Australian
Island's phase 2a/b dengue results in May
Island Pharmaceutical's phase 2a/b PROTECT trial using ISLA-101 in dengue fever completed High level results of PROTECT trial which included two patient cohorts to be reported next month Pharmacokinetic data from phase 2b cohort received with dosing regimen achieving target blood concentration in all participants Special Report: Antiviral drug development company Island Pharmaceuticals has completed treatment follow up in its phase 2a/b PROTECT trial using lead candidate ISLA-101 in dengue fever with results expected next month. The Island Pharmaeutical (ASX:ILA) phase 2a/b PROTECT trial included two patient cohorts, with the Phase 2a arm examining the prophylactic (preventative) arm of ISLA-101 in dengue fever in four subjects randomised 3:1 (active:placebo). The phase 2b arm involves 10 subjects, randomised 8:2 (active:placebo) and is assessing if ISLA-101 can reduce virus level and symptoms in subjects already infected with the dengue challenge virus, a weakened strain of dengue virus developed by the US Army. During phase 2a, the trial's safety review committee (SRC) deemed ISLA-101 safe and exhibited evidence of anti-dengue activity. The SRC noted that blood levels of ISLA-101 were as desired, and given positive safety and antiviral signals, recommended that Island proceed with the Phase 2b therapeutic cohort. The SRC's recommendation was submitted to the US Food and Drug Administration (FDA) as requested by the regulator, which led to the start of phase 2b of the trial. Island subsequently completed Phase 2b enrolment and dosing on schedule and with no delays in February. Follow-up procedures necessary to obtain samples to analyse primary and secondary endpoints for the Phase 2b cohort have also been successfully completed. Data obtained and pending results Island has received pharmacokinetic (PK) data from the Phase 2b cohort, which showed target blood concentration in all subjects was achieved. The company said data to examine virus levels from Phase 2a and 2b was expected by the end of this month. Upon receipt and analysis of the data, Island anticipates locking the study database within around two weeks, after which all data will be unblinded. Following close consultation with regulatory advisors and Island's scientific consultants and given the short time between receipt of data and locking the database, Island said it had decided not to undertake an interim readout. Moreover, the FDA has not requested an interim review of data, in contrast to their request following the Phase 2a cohort. Island said this would serve to maintain its data integrity, preserve statistical power of the results and have a positive impact on future engagement with regulatory bodies. Island expects that high level, unblinded data for both cohorts will be reported before the end of May. Potential of ISLA-101 to treat and prevent dengue Dengue fever is the most prevalent mosquito-borne viral disease and, according to the World Health Organization, its incidence has grown dramatically around the world in recent decades, with no specific treatment. CEO and managing director Dr David Foster said Island was pleased to provide an update the Phase 2a/b PROTECT trial, which has the potential to show ISLA-101's use in both a preventative and therapeutic for dengue. 'Following completion of patient follow up for phase 2b cohort, I am pleased to advise that the trial was executed to the highest standard, per our protocol which was previously approved by the US FDA,' he said. 'Further to this, the receipt of initial PK data has shown that desired target blood concentration of ISLA-101 was achieved in Phase 2b participants, similar to what was observed in Phase 2a subjects. 'Following receipt of strong interim data from the phase 2a cohort, the board and management remain confident in the pending results and look forward to providing additional updates in the coming weeks.' This article was developed in collaboration with Island Pharmaceuticals, a Stockhead advertiser at the time of publishing. This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
