Latest news with #ISLA-101
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.
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.
