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Yahoo
21 hours ago
- Business
- Yahoo
Immunic Announces Completion of Enrollment for Both Phase 3 ENSURE Trials in Relapsing MS and Presents Additional Data Underlining Positive Outcome of Phase 2 CALLIPER Trial in Progressive MS
– Enrollment Completed for Both Phase 3 ENSURE Trials of Vidofludimus Calcium in Relapsing Multiple Sclerosis; Top-Line Data Expected End of 2026 – – Additional Data from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis Further Supports the Recently Released Positive Top-Line Results and Further Underlines Vidofludimus Calcium's Neuroprotective Potential – – New CALLIPER Data Regarding Time to 24-Week Confirmed Disability Worsening Shows Substantial and Medically Relevant Reductions for Vidofludimus Calcium Over Placebo in the Overall Study Population and Major Disease Subtypes – NEW YORK, June 5, 2025 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases, announced the completion of enrollment for both phase 3 ENSURE trials of lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing multiple sclerosis and additional phase 2 CALLIPER trial data in patients with progressive multiple sclerosis underlining the recently released positive top-line results. Enrollment Completed for Both Phase 3 ENSURE Trials in Relapsing Multiple Sclerosis (RMS) The ENSURE program comprises two identical multicenter, randomized, double-blind phase 3 trials designed to evaluate the efficacy, safety and tolerability of vidofludimus calcium versus placebo in RMS patients. Each of the trials, titled ENSURE-1 and ENSURE-2, enrolled adult patients with active RMS at more than 100 sites in 15 countries, including the United States, India and countries in the Middle East and North Africa (MENA) region, Latin America, and Central and Eastern Europe. In total, 1,121 patients in ENSURE-1 and 1,100 patients in ENSURE-2 have been randomized in a double-blinded fashion to either 30 mg daily doses of vidofludimus calcium or placebo. The primary endpoint for both trials is time to first relapse up to 72 weeks. Secondary endpoints include time to confirmed disability worsening based on the Expanded Disability Status Scale (EDSS), volume of new T2-lesions, time to sustained clinically relevant changes in cognition, and magnetic resonance imaging (MRI)-based endpoints. "The on-schedule enrollment of the final patients in our phase 3 ENSURE trials of vidofludimus calcium marks another significant milestone for our late-stage MS program, bringing us meaningfully closer to a potential new treatment option for people living with RMS," commented Daniel Vitt, Ph.D., Chief Executive Officer of Immunic. "We anticipate that the drug's unique neuroprotective effects observed to date will also play a crucial role in the ENSURE trials, where confirmed disability worsening serves as an important secondary outcome. If approved, we believe vidofludimus calcium, with its attractive safety and tolerability profile, compelling dual and novel mechanism of action and combination of neuroprotective, anti-inflammatory, and antiviral effects, could potentially transform the oral MS therapy market, offering a unique first-in-class treatment option by addressing the full spectrum of this disease. We eagerly anticipate the top-line data from both ENSURE trials by the end of 2026, which allows for a synchronized readout and a pooled assessment of the confirmed disability worsening secondary endpoint." Werner Gladdines, Chief Development Officer of Immunic, added, "We are extremely proud to have reached this key milestone for our ENSURE program of vidofludimus calcium, right on schedule. Successfully completing enrollment of over 2,200 RMS patients across the twin phase 3 trials represents a major achievement and a true team effort. We extend our sincere thanks to all Immunic colleagues and vendor staff involved in the planning and execution of the ENSURE trials for their dedication to advancing our late-stage clinical program. We are also deeply grateful for the strong support from our clinical investigators, site study teams, and the study participants and their families. We look forward to analyzing the ENSURE top-line data, which we hope will ultimately pave the way for regulatory filings and the ultimate commercialization of vidofludimus calcium in RMS." Additional Data Available from Phase 2 CALLIPER Trial in Progressive Multiple Sclerosis (PMS) Building on the recently released data showing reductions in the relative risk of 24-week confirmed disability worsening (24wCDW) events based on the Expanded Disability Status Scale (EDSS) at the end of the main treatment period, newly available data for the secondary endpoint of time to 24wCDW based on the EDSS further reinforces the neuroprotective potential of vidofludimus calcium. In the overall PMS patient population (n=467), vidofludimus calcium demonstrated a clinically meaningful reduction of the hazard ratio (HR) for 24wCDW by 24% compared to placebo (HR 0.76). Further analyses by disease subtype showed that vidofludimus calcium was associated with a 33% reduction in 24wCDW in the primary progressive multiple sclerosis (PPMS) study population (n=152) compared to placebo (HR 0.67), a 19% reduction in the non-active secondary progressive multiple sclerosis (naSPMS) study population (n=268) compared to placebo (HR 0.81), and a 34% reduction in the active secondary progressive multiple sclerosis (aSPMS) study population (n=47) compared to placebo (HR 0.66). Similarly, consistent with the recent top-line data, further analyses of subpopulations – both with and without inflammatory gadolinium-enhanced lesion activity at baseline, who are largely shown to not benefit from current anti-inflammatory therapies – continued to demonstrate promising results. For the overall population, vidofludimus calcium reduced 24wCDW in patients without evidence of gadolinium-enhancing lesions at baseline by 34% compared to placebo (HR 0.66). Encouraging results were likewise observed for the PPMS (reduction in 24wCDW: 35%; HR 0.65) and naSPMS (reduction in 24wCDW: 30%; HR 0.70) study populations compared to placebo. "Our recently released positive phase 2 CALLIPER trial data in PMS underlined vidofludimus calcium's neuroprotective potential and its ability to slow disease progression in MS patients with or without focal inflammation. We are very excited that additional analyses of time to 24-week confirmed disability worsening further support this potential, highlighting a significant opportunity ahead," stated Dr. Vitt. "The consistent results for 24wCDW between the general CALLIPER population and patients that show no evidence of focal inflammatory disease at baseline, as exemplified by gadolinium-enhancing lesions during MRI, both for the overall study population and for the PPMS and naSPMS subtypes, supports clinically measurable neuroprotective effects of vidofludimus calcium, consistent with its Nurr1 activation mechanism. We believe, because 24wCDW is an acceptable regulatory endpoint to determine clinical benefit in PMS, the suggestive evidence of clinical activity in 24wCDW clearly deserves further investigation in a phase 3 program." About Vidofludimus Calcium (IMU-838)Vidofludimus calcium is an orally administered investigational small molecule drug being developed for chronic inflammatory and autoimmune diseases, currently in late-stage clinical trials for multiple sclerosis (MS). Uniquely, vidofludimus calcium's first-in-class, dual mode of action combines neuroprotective, anti-inflammatory and anti-viral effects to target the complex pathophysiology of MS. As a selective immune modulator, it activates the neuroprotective transcription factor, nuclear receptor-related 1 (Nurr1), which provides direct and indirect neuroprotective effects. Additionally, vidofludimus calcium achieves anti-inflammatory and anti-viral effects through highly selective inhibition of the enzyme dihydroorotate dehydrogenase (DHODH). Vidofludimus calcium is currently being evaluated in phase 3 clinical trials for the treatment of relapsing MS. In a phase 2 clinical trial, it has shown therapeutic activity in relapsing-remitting MS patients, significantly reducing brain lesions and demonstrating encouraging results in reducing confirmed disability worsening. Additionally, vidofludimus calcium has demonstrated clinical benefits in progressive MS patients by showing substantial reductions in confirmed disability worsening and thalamic brain volume in a phase 2 clinical trial. To date, vidofludimus calcium has been exposed to approximately 2,700 individuals and has shown an attractive pharmacokinetic, safety and tolerability profile. Vidofludimus calcium is not yet licensed or approved in any country. About Immunic, Inc. (Nasdaq: IMUX) is a biotechnology company developing a clinical pipeline of orally administered, small molecule therapies for chronic inflammatory and autoimmune diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in patients suffering from relapsing-remitting multiple sclerosis and progressive multiple sclerosis. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). IMU-856, which targets the protein Sirtuin 6 (SIRT6), is intended to restore intestinal barrier function and regenerate bowel epithelium, which could potentially be applicable in numerous gastrointestinal diseases, such as celiac disease as well as inflammatory bowel disease, Graft-versus-Host-Disease and weight management. IMU-381, which currently is in preclinical testing, is a next generation molecule being developed to specifically address the needs of gastrointestinal diseases. For further information, please visit: Cautionary Statement Regarding Forward-Looking StatementsThis press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for vidofludimus calcium to safely and effectively target diseases; preclinical and clinical data for vidofludimus calcium; the feasibility of advancing vidofludimus calcium to a confirmatory phase 3 clinical trial in progressive multiple sclerosis; the timing of current and future clinical trials and anticipated clinical milestones; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the SEC on March 31, 2025, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, BreuVice President Investor Relations and Communications+49 89 2080 477 US IR ContactRx Communications GroupPaula Schwartz+1 917 633 7790immunic@ US Media ContactKCSA Strategic CommunicationsCaitlin Kasunich+1 212 896 1241ckasunich@ View original content to download multimedia: SOURCE Immunic, Inc. Sign in to access your portfolio
Yahoo
08-05-2025
- Health
- Yahoo
Brii Bio Presents Late-Breaking Data from Its Ongoing Phase 2 ENSURE Study at EASL Congress 2025, Suggesting BRII-179's Role in Advancing Higher HBsAg Loss
Interim data from Cohort 4 showed that anti-HBs responders achieved a substantially higher rate of HBsAg seroclearance than non-responders. At EOT (Week 48), 61% (11/18) of anti-HBs responders achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders. Among the 11 anti-HBs responders who achieved HBsAg loss, 91% (10/11) had anti-HBs titers ≥ 100 IU/L at EOT. Cohort 4 enrolled participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran in a previous APAC study BRII-179-835-001 (NCT04749368) to receive elebsiran and PEG-IFNα combination treatment. These participants were grouped based on their anti-HBs response induced by prior BRII-179 treatment: those with peak anti-HBs titers ≥ 10 IU/L are defined as anti-HBs responders, and those with peak anti-HBs titers < 10 IU/L as non-responders. The design of Cohort 4 as part of this study was based on the insight that BRII-179 could differentiate between immune responders and non-responders, offering the potential to predict future response to therapy. ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), to the combination treatment with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL. DURHAM, N.C. and BEIJING, May 8, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical need, today announced data from its ongoing Phase 2 ENSURE study as late-breaking posters at the European Association for the Study of the Liver (EASL) Congress 2025 in Amsterdam, the Netherlands. 24 Week follow-up results from Cohorts 1-3 of the ENSURE study demonstrated sustained off-treatment benefits of elebsiran + PEG-IFNα combination therapy vs PEG-IFNα alone End of treatment (EOT) data from Cohort 4 of the ENSURE study suggest that patients responding to prior BRII-179 treatment achieved faster and higher rate of surface antigen clearance with curative treatments compared to BRII-179 naïve participants , strengthening the case for a novel enrichment strategy, utilizing BRII-179 to identify and prime patients for improved functional cure outcomes Story Continues Of note, BRII-179 experienced participants in Cohort 4 achieved HBsAg loss faster than BRII-179 naïve participants in Cohort 2 and 3. 83% (10/12) of HBsAg loss in BRII-179 experienced participants occurred by Week 24, compared to 55% (6/11) in BRII-179 naïve participants. These findings suggest rapid HBsAg seroclearance in subjects with higher anti-HBs titers may translate into durable HBsAg loss and the potential to evaluate shorter treatment durations of PEG-IFNα. Additional data from Cohorts 1-3 of the ENSURE study showed the combination therapy of elebsiran either 100 mg or 200 mg and PEG-IFNα resulted in higher HBsAg loss rate at 24 weeks post EOT compared to PEG-IFNα alone, supporting the additive benefit of siRNA. "The data from Cohort 4 of the ENSURE study are encouraging. We saw in target populations that patients who were immune-responsive through pre-treatment with BRII-179 demonstrated a significant advantage in achieving a higher HBsAg seroclearance rate," said David Margolis, MD, Chief Medical Officer of Brii Bio. "With BRII-179, we may identify patients with less impaired intrinsic immunity and further prime their immune response. This approach may provide more durable HBsAg loss and potentially shorter treatment duration of PEG-IFNα. We are moving full speed ahead with our clinical efforts to deliver a meaningful option to the chronic hepatitis B patients long left waiting." Abstract Number: LB25123/ LBP-018 Title: Chronic hepatitis B virus infected participants responding to prior BRII-179 treatment achieved faster and higher rate of hepatitis B virus surface antigen seroclearance on elebsiran plus pegylated interferon-alfa: end of treatment data from ENSURE study Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China A total of 28 participants with baseline HBsAg > 100 and ≤ 3000 IU/mL were analyzed. 18 and 10 participants had peak anti-HBs titer ≥ 10 IU/L (defined as anti-HBs responders) and < 10 IU/L (defined as non-responders) induced by BRII-179 in the previous study, respectively. Median [range] HBsAg at the time of initiating elebsiran + PEG-IFNα was numerically higher in anti-HBs responders (539.4 [106.7-2165.0] IU/mL) than in non-responders (219.3 [106.7-671.5] IU/mL). At EOT (Week 48), 61% (11/18) of anti-HBs responders achieved HBsAg seroclearance, compared to 10% (1/10) of non-responders. Among the anti-HBs responders who lost HBsAg, 91% (10/11) had anti-HBs titers ≥ 100 IU/L at EOT. BRII-179 experienced participants achieved HBsAg loss faster than BRII-179 naïve participants, with 83% (10/12) of HBsAg loss occurring by Week 24 (vs 55% [6/11] in BRII-179 naïve participants). Elebsiran + PEG-IFNα was generally safe and tolerated in BRII-179 experienced participants. Abstract Number: LB25115/ LBP-016 Title: Efficacy and safety of elebsiran and pegylated interferon alfa combination therapy versus pegylated interferon alfa in participants with chronic hepatitis B virus infection: follow-up results from the ongoing phase 2, randomized, open-label ENSURE study Presenter: David Margolis, MD, MPH, Chief Medical Officer of Brii Biosciences At Week 72 (24 weeks post EOT), higher HBsAg loss rate was observed in participants on combination therapy of either elebsiran 200mg or 100 mg and PEG-IFNα compared to PEG-IFNα alone (21.1% [4/19] or 33.3% [6/18] vs 5.6% [1/18]). All the 11 participants with HBsAg loss had baseline HBsAg < 1500 IU/mL. Incidence of treatment emergent adverse events (TEAEs) was comparable between combination therapy cohorts and PEG-IFNα alone cohort. Most TEAEs were consistent with known side effects of PEG-IFNα. As part of Brii Bio's unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179 being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio; and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at scientific conferences throughout 2025. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation. About Elebsiran (previously known as BRII-835, VIR-2218) Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit [1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from [2] World Health Organization. Hepatitis. World Health Organization. Retrieved from Cision View original content to download multimedia: SOURCE Brii Biosciences Limited
Associated Press
30-03-2025
- Business
- Associated Press
Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179's Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification
Preliminary data from Cohort 4 of the ENSURE study supports a novel enrichment strategy to utilize BRII-179 to identify patients who are immune responders and have the potential to achieve higher HBsAg loss at EOT 48-week EOT data from Cohort 1-3 of the ENSURE study clearly suggests the added benefits of elebsiran towards achieving a higher rate of HBsAg loss in combination with PEG-IFNα DURHAM, N.C. and BEIJING, China, March 30, 2025 /PRNewswire/ -- Brii Biosciences Limited ('Brii Bio,' or the 'Company', stock code: a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs, announced new data from its ongoing Phase 2 ENSURE study as a late-breaking oral presentation at the 34th Annual Meeting of Asian Pacific Association for the Study of the Liver (APASL 2025) in Beijing, China. ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), in combination with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL. Participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran (BRII-835) in a previous APAC study BRII-179-835-001 (NCT04749368) were enrolled to Cohort 4 of this study and received elebsiran and PEG-IFNα combination treatment. The design of Cohort 4 as part of this study was based on insight from previous studies that a significant proportion of the chronic HBV patients fail to generate a sufficient immune response after receiving multiple doses of BRII-179, and therefore unlikely to have the immune support to achieve sustainable functional cure. Emerging data from Cohort 4 showed that participants who previously had BRII-179 induced anti-HBs response achieved a substantially higher rate of HBsAg seroclearance than those who did not. At Week 24, more than half of the BRII-179 responders (55.6% [10/18]) achieved HBsAg seroclearance, compared to only 10.0% (1/10) in non-responders. These latest data suggest that BRII-179 can serve as a predictive tool for enriching patients more likely to respond to curative therapies. Additional data from Cohorts 1-3 of the ENSURE study showed that higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants receiving elebsiran in combination with PEG-IFNα than those receiving PEG-IFNα alone. 'The positive Cohort 4 data from the ENSURE study opens new doors for HBV functional cure,' said Dr. Grace Lai-Hung Wong, Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China. 'Previous studies have suggested that BRII-179 may offer a unique opportunity to identify CHB patients who are able to elicit the necessary HBsAg antibody response. I believe these new findings provide clear evidence supporting such value proposition and further substantiate the role of BRII-179 in shaping future combination therapies.' 'We are encouraged that the Cohort 4 from the ENSURE study continue to support our enrichment strategy in developing a functional cure for chronic HBV in target populations,' said David Margolis, MD, Chief Medical Officer of Brii Bio. 'The results underscore the potential of BRII-179 in identifying patients who are more likely to respond to regimens aimed at functional cure, thereby enhancing functional cure rates in the target population while reducing exposure to costly therapies for those with a lower probability of cure. We are committed to advancing BRII-179 in combination with various modalities through our ongoing studies and collaborations with strategic partners, aiming to deliver higher functional cure rates to 254 million patients worldwide living with chronic HBV infection.' Abstract Number: OP0335 Presentation Title: Responders to Prior BRII-179 Treatment Achieved Faster and Higher Rate of HBsAg Seroclearance Following Treatment of Elebsiran and PEG-IFNα in Participants with Chronic Hepatitis B Virus Infection: Preliminary Data from ENSURE Study Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China Among the 28 of the 31 participants enrolled in Cohort 4 with baseline HBsAg ≥ 100 IU/mL being analyzed, 18 participants with peak anti-HBs ≥ 10 IU/L induced by prior BRII-179 treatment were defined as BRII-179 responders and 10 participants with peak anti-HBs < 10 IU/L were defined as non-responders. At Week 24 of treatment with elebsiran + PEG-IFNα, 39.3% (11/28) of the Cohort 4 participants achieved HBsAg seroclearance. The rate of HBsAg seroclearance at Week 24 in the BRII-179 responders was 55.6% (10/18), notably higher compared to the non-responders at 10% (1/10). Responders to prior BRII-179 treatment appeared to achieve a faster HBsAg seroclearance compared to BRII-179 naïve participants receiving elebsiran + PEG-IFNα as previously reported. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Treatment with elebsiran + PEG-IFNα is ongoing for 48 weeks. Abstract Number: LB0009 Presentation Title: Higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants with chronic HBV infection receiving elebsiran (BRII-835) and pegylated interferon alfa-2a (PEG-IFNα) compared to PEG-IFNα alone: Week 48 results from ongoing ENSURE study Presenter: Jidong Jia, M.D., Ph.D., Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in Beijing, China The rates of HBsAg seroclearance at EOT in elebsiran 200 mg + PEG-IFNα and elebsiran 100 mg + PEG-IFNα cohorts were 26.3% (5/19) and 33.3% (6/18), respectively, notably higher compared to PEG-IFNα alone cohort (5.6%) in participants with baseline HBsAg levels 100-3,000 IU/mL. Greater HBsAg reductions at EOT were observed in elebsiran + PEG-IFNα combination cohorts (mean [SE]: -2.47 [0.28] or -3.01 [0.28] log10 IU/mL in elebsiran 200 mg or 100 mg, respectively) than in PEG-IFNα cohort (-1.02 [0.30] log10 IU/mL). Elebsiran in combination with PEG-IFNα at both 200 mg and 100 mg doses achieved similar HBsAg reductions and seroclearance rates. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Post-treatment follow-up is ongoing and will continue for 24 weeks after discontinuation of treatment. As part of Brii Bio's unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179, a recombinant protein-based HBV immunotherapeutic being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at the scientific conferences throughout 2025. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the 'CDE') of the National Medical Products Administration (the 'NMPA') granted BRII-179 Breakthrough Therapy Designation. About Elebsiran (BRII-835, VIR-2218) Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. About Brii Bio Brii Biosciences Limited ('Brii Bio', stock code: is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit
Yahoo
30-03-2025
- Business
- Yahoo
Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179's Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification
Preliminary data from Cohort 4 of the ENSURE study supports a novel enrichment strategy to utilize BRII-179 to identify patients who are immune responders and have the potential to achieve higher HBsAg loss at EOT 48-week EOT data from Cohort 1-3 of the ENSURE study clearly suggests the added benefits of elebsiran towards achieving a higher rate of HBsAg loss in combination with PEG-IFNα DURHAM, N.C. and BEIJING, China, March 30, 2025 /PRNewswire/ -- Brii Biosciences Limited ("Brii Bio," or the "Company", stock code: a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet medical needs, announced new data from its ongoing Phase 2 ENSURE study as a late-breaking oral presentation at the 34th Annual Meeting of Asian Pacific Association for the Study of the Liver (APASL 2025) in Beijing, China. ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), in combination with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL. Participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran (BRII-835) in a previous APAC study BRII-179-835-001 (NCT04749368) were enrolled to Cohort 4 of this study and received elebsiran and PEG-IFNα combination treatment. The design of Cohort 4 as part of this study was based on insight from previous studies that a significant proportion of the chronic HBV patients fail to generate a sufficient immune response after receiving multiple doses of BRII-179, and therefore unlikely to have the immune support to achieve sustainable functional cure. Emerging data from Cohort 4 showed that participants who previously had BRII-179 induced anti-HBs response achieved a substantially higher rate of HBsAg seroclearance than those who did not. At Week 24, more than half of the BRII-179 responders (55.6% [10/18]) achieved HBsAg seroclearance, compared to only 10.0% (1/10) in non-responders. These latest data suggest that BRII-179 can serve as a predictive tool for enriching patients more likely to respond to curative therapies. Additional data from Cohorts 1-3 of the ENSURE study showed that higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants receiving elebsiran in combination with PEG-IFNα than those receiving PEG-IFNα alone. "The positive Cohort 4 data from the ENSURE study opens new doors for HBV functional cure," said Dr. Grace Lai-Hung Wong, Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China. "Previous studies have suggested that BRII-179 may offer a unique opportunity to identify CHB patients who are able to elicit the necessary HBsAg antibody response. I believe these new findings provide clear evidence supporting such value proposition and further substantiate the role of BRII-179 in shaping future combination therapies." "We are encouraged that the Cohort 4 from the ENSURE study continue to support our enrichment strategy in developing a functional cure for chronic HBV in target populations," said David Margolis, MD, Chief Medical Officer of Brii Bio. "The results underscore the potential of BRII-179 in identifying patients who are more likely to respond to regimens aimed at functional cure, thereby enhancing functional cure rates in the target population while reducing exposure to costly therapies for those with a lower probability of cure. We are committed to advancing BRII-179 in combination with various modalities through our ongoing studies and collaborations with strategic partners, aiming to deliver higher functional cure rates to 254 million patients worldwide living with chronic HBV infection." Abstract Number: OP0335 Presentation Title: Responders to Prior BRII-179 Treatment Achieved Faster and Higher Rate of HBsAg Seroclearance Following Treatment of Elebsiran and PEG-IFNα in Participants with Chronic Hepatitis B Virus Infection: Preliminary Data from ENSURE Study Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR, China Among the 28 of the 31 participants enrolled in Cohort 4 with baseline HBsAg ≥ 100 IU/mL being analyzed, 18 participants with peak anti-HBs ≥ 10 IU/L induced by prior BRII-179 treatment were defined as BRII-179 responders and 10 participants with peak anti-HBs < 10 IU/L were defined as non-responders. At Week 24 of treatment with elebsiran + PEG-IFNα, 39.3% (11/28) of the Cohort 4 participants achieved HBsAg seroclearance. The rate of HBsAg seroclearance at Week 24 in the BRII-179 responders was 55.6% (10/18), notably higher compared to the non-responders at 10% (1/10). Responders to prior BRII-179 treatment appeared to achieve a faster HBsAg seroclearance compared to BRII-179 naïve participants receiving elebsiran + PEG-IFNα as previously reported. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Treatment with elebsiran + PEG-IFNα is ongoing for 48 weeks. Abstract Number: LB0009 Presentation Title: Higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants with chronic HBV infection receiving elebsiran (BRII-835) and pegylated interferon alfa-2a (PEG-IFNα) compared to PEG-IFNα alone: Week 48 results from ongoing ENSURE study Presenter: Jidong Jia, M.D., Ph.D., Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in Beijing, China The rates of HBsAg seroclearance at EOT in elebsiran 200 mg + PEG-IFNα and elebsiran 100 mg + PEG-IFNα cohorts were 26.3% (5/19) and 33.3% (6/18), respectively, notably higher compared to PEG-IFNα alone cohort (5.6%) in participants with baseline HBsAg levels 100-3,000 IU/mL. Greater HBsAg reductions at EOT were observed in elebsiran + PEG-IFNα combination cohorts (mean [SE]: -2.47 [0.28] or -3.01 [0.28] log10 IU/mL in elebsiran 200 mg or 100 mg, respectively) than in PEG-IFNα cohort (-1.02 [0.30] log10 IU/mL). Elebsiran in combination with PEG-IFNα at both 200 mg and 100 mg doses achieved similar HBsAg reductions and seroclearance rates. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection. Post-treatment follow-up is ongoing and will continue for 24 weeks after discontinuation of treatment. As part of Brii Bio's unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179, a recombinant protein-based HBV immunotherapeutic being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at the scientific conferences throughout 2025. About Hepatitis B Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in China, where 87 million people are chronically infected.[2] About BRII-179 BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation. About Elebsiran (BRII-835, VIR-2218) Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020. About Brii Bio Brii Biosciences Limited ("Brii Bio", stock code: is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the San Francisco Bay Area, Beijing and Shanghai. For more information, visit [1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from [2] World Health Organization. Hepatitis. World Health Organization. Retrieved from View original content to download multimedia: SOURCE Brii Biosciences Limited
