– Section 1a research will consider single and a number of ascending doses of ABI-6250 in wholesome contributors with information anticipated in Q3 2025 –
– Biomarker of ABI-6250 goal engagement, serum bile acids, shall be assessed along with security and pharmacokinetic measures –
SOUTH SAN FRANCISCO, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) — Meeting Biosciences, Inc. ASMB, a biotechnology firm creating modern therapeutics concentrating on severe viral ailments, at this time introduced that the primary participant has been dosed within the Section 1a trial of ABI-6250, the corporate’s orally bioavailable, small molecule hepatitis delta virus (HDV) entry inhibitor candidate.
This Section 1a research will consider the protection, tolerability and pharmacokinetics (PK) of ABI-6250 throughout single and a number of ascending dose cohorts in wholesome contributors. As well as, the research will take a look at serum bile acids as a biomarker of ABI-6250’s engagement of its goal, the transporter utilized by HDV to contaminate hepatocytes (sodium taurocholate cotransporting polypeptide or NTCP). Meeting Bio expects to share information from the Section 1a research in Q3 2025.
At the moment, one remedy is accepted for power HDV an infection (cHDV) within the European Union with no therapies accepted in the US. This accepted remedy is a peptide inhibitor of NTCP requiring each day injections. Properly-tolerated serum bile acid elevations have been noticed clinically with the accepted NTCP inhibitor.
“ABI-6250 has the potential to be the primary oral remedy for cHDV, a life-threatening power viral an infection with restricted remedy choices out there,” mentioned Anuj Gaggar, MD, PhD, chief medical officer of Meeting Bio. “Power HDV is essentially the most extreme type of viral hepatitis with 70% of people with cHDV progressing to cirrhosis inside 10 years, and we’re excited to have medical research underway for this candidate with the potential to simplify cHDV remedy.”
In preclinical research, ABI-6250 has demonstrated low nanomolar efficiency throughout a number of HDV genotypes in vitro, selectivity for NTCP versus different bile acid transporters and a PK profile supportive of once-daily oral dosing.
ABI-6250 is an investigational product candidate that has not been accepted anyplace globally, and its security and efficacy haven’t been established.
About ABI-6250-101
ABI-6250-101 is a randomized, blinded and placebo-controlled Section 1a medical research evaluating the protection, tolerability and PK of ABI-6250 following single and a number of ascending dose administration. Wholesome contributors shall be randomized between ABI-6250 and placebo in as much as 5 single-dose and 5 multiple-dose cohorts at totally different doses. A number of-dose cohorts will consider repeat dosing over 10 days.
Along with assessing security, tolerability and PK, this Section 1a research may also measure adjustments in serum bile acid ranges, a biomarker of NTCP engagement. The trial outcomes will help dose choice for future medical research.
Further details about the Section 1a trial is accessible at clinicaltrials.gov utilizing the identifier NCT06740474.
About Meeting Biosciences
Meeting Biosciences is a biotechnology firm devoted to the event of modern small-molecule therapeutics designed to alter the trail of great viral ailments and enhance the lives of sufferers worldwide. Led by an achieved workforce of leaders in virologic drug growth, Meeting Bio is dedicated to enhancing outcomes for sufferers battling the intense, power impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For extra info, go to assemblybio.com.
Ahead-Wanting Statements
The knowledge on this press launch comprises forward-looking statements which might be topic to sure dangers and uncertainties that might trigger precise outcomes to materially differ. These dangers and uncertainties embrace: Meeting Bio’s means to take care of monetary assets essential to proceed its analysis actions, medical research and different enterprise operations; Meeting Bio’s means to appreciate the potential advantages of its collaboration with Gilead Sciences, Inc., together with all monetary features of the collaboration and fairness investments; Meeting Bio’s means to provoke and full medical research involving its therapeutic product candidates, together with research contemplated by Meeting Bio’s collaboration with Gilead, within the at the moment anticipated timeframes or in any respect; security and efficacy information from medical or nonclinical research could not warrant additional growth of Meeting Bio’s product candidates; medical and nonclinical information introduced at conferences could not differentiate Meeting Bio’s product candidates from different corporations’ candidates; outcomes of nonclinical research will not be consultant of illness conduct in a medical setting and will not be predictive of the outcomes of medical research; and different dangers recognized every now and then in Meeting Bio’s studies filed with the U.S. Securities and Alternate Fee (the SEC). You’re urged to contemplate statements that embrace the phrases could, will, would, might, ought to, would possibly, believes, hopes, estimates, initiatives, potential, expects, plans, anticipates, intends, continues, forecast, designed, purpose or the unfavourable of these phrases or different comparable phrases to be unsure and forward-looking. Meeting Bio intends such forward-looking statements to be lined by the secure harbor provisions contained in Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Alternate Act of 1934, as amended. Extra details about Meeting Bio’s dangers and uncertainties are extra totally detailed beneath the heading “Threat Components” in Meeting Bio’s filings with the SEC, together with its most up-to-date Annual Report on Type 10-Ok, Quarterly Reviews on Type 10-Q and Present Reviews on Type 8-Ok. Besides as required by legislation, Meeting Bio assumes no obligation to replace publicly any forward-looking statements, whether or not on account of new info, future occasions or in any other case.
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