Assembly Biosciences Doses First Participant in Phase 1b Clinical Trial Evaluating Next-Generation Capsid Assembly Modulator Candidate ABI-4334 for the Treatment of Chronic Hepatitis B Virus Infection
Assembly Biosciences (Nasdaq: ASMB) has dosed the first participant in its Phase 1b clinical trial for ABI-4334, a next-generation capsid assembly modulator (CAM) targeting chronic hepatitis B virus (HBV) infection. The trial aims to evaluate the safety, pharmacokinetics, and efficacy of ABI-4334 over a 28-day period. Interim data is expected by the end of 2024. ABI-4334 has shown promising preclinical results with strong antiviral activity and is optimized to inhibit HBV DNA replication and prevent cccDNA formation. Chronic HBV is a leading cause of chronic liver disease and liver transplants, making this study important for potential therapeutic advancements.
- Assembly Biosciences has initiated dosing in its Phase 1b trial for ABI-4334, showing progress in their clinical pipeline.
- ABI-4334 has demonstrated promising preclinical results with strong antiviral activity and favorable safety and pharmacokinetic profiles.
- The trial aims to refine projected activity against cccDNA formation and generate key safety data, potentially leading to best-in-class antiviral therapy.
- Interim data from the study is expected by the end of 2024, providing a clear timeline for investors and stakeholders.
- The trial is still in early stages (Phase 1b), which means it could be years before ABI-4334 potentially reaches the market.
- Interim data is not expected until the end of 2024, extending the timeline for potential market impact.
- Current treatments for chronic HBV are lifelong, and the efficacy of ABI-4334 in permanently eliminating the virus remains unproven in clinical settings.
Insights
The initiation of the Phase 1b clinical trial for Assembly Biosciences' ABI-4334 is a significant milestone in the development of new treatments for chronic hepatitis B virus (HBV) infection. Chronic HBV is a critical public health issue, causing severe liver disease and being a leading reason for liver transplants globally. Current treatments reduce the virus but do not eliminate it, leading to lifelong management for patients.
Capsid assembly modulators (CAMs) like ABI-4334 offer a promising new approach. By inhibiting HBV DNA replication and preventing the formation of new cccDNA – the viral pool that allows reactivation of the virus – CAMs could potentially offer a more effective treatment regimen. The favorable safety and pharmacokinetic profile observed in Phase 1a trials is promising, indicating that ABI-4334 can achieve significant antiviral activity.
In vitro potency in the nanomolar range is particularly notable. It suggests that ABI-4334 might have strong antiviral effects in real-world usage. The ongoing Phase 1b trials will provide essential data on its safety and effectiveness in actual patients with chronic HBV, potentially confirming its best-in-class status.
If successful, ABI-4334 could transform the treatment landscape for chronic HBV, offering a more effective and potentially curative option. However, it's important to remain cautious until the final results are available, as clinical trials can yield unexpected outcomes.
Assembly Biosciences' progression to a Phase 1b trial for ABI-4334 indicates a potential future revenue stream for the company if the drug proves successful. Chronic hepatitis B treatment is a large and under-served market, with current therapies offering limited efficacy and requiring lifelong administration. A potent, possibly curative treatment could capture significant market share.
The fact that ABI-4334 has shown positive preclinical and Phase 1a results suggests a strong likelihood of continued progress. Investors should note the projected timeline, with interim data expected by the end of 2024. This timeline provides a clear milestone that could affect stock performance based on data outcomes.
However, investors should also consider the inherent risks of biotechnology investments, particularly in early-stage clinical trials. The outcome of these trials is inherently uncertain and negative results could significantly impact Assembly Biosciences' stock price. On the other hand, positive interim results could lead to substantial stock appreciation and potential partnership or acquisition opportunities.
The hepatitis B market represents a substantial opportunity, with millions affected globally and current treatments being suboptimal. The introduction of a next-generation CAM like ABI-4334 could potentially disrupt the existing market dynamics. The unmet need for more effective treatments that can reduce or eliminate the virus is significant, offering a lucrative opportunity for Assembly Biosciences.
Given the favorable early-stage data and the fact that ABI-4334 targets both HBV DNA replication and cccDNA formation, it holds promise for addressing a broader spectrum of the virus lifecycle compared to existing therapies. This dual mechanism could position ABI-4334 as a preferred treatment option if it can achieve superior clinical outcomes.
However, market penetration will depend not only on clinical success but also on factors like pricing, reimbursement and competition from other emerging therapies. Investors should keep an eye on developments in these areas as they could impact the long-term commercial success of ABI-4334.
– Phase 1b study will evaluate safety, pharmacokinetic and efficacy endpoints in participants with chronic hepatitis B virus infection with interim data expected by the end of 2024 –
SOUTH SAN FRANCISCO, Calif., June 18, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced that the first participant has been dosed in the Phase 1b trial of ABI-4334, a next-generation capsid assembly modulator (CAM) candidate in development for the treatment of chronic hepatitis B virus (HBV) infection.
Chronic HBV (cHBV) infection is a leading cause of chronic liver disease and liver transplants globally, with the World Health Organization estimating that over one million people died in 2022 from HBV-related causes. Current treatments are lifelong and reduce, but do not eliminate, the virus with very low cure rates. CAMs are direct-acting antivirals with two distinct mechanisms of action, inhibition of HBV DNA replication and prevention of the formation of new cccDNA, the viral reservoir. ABI-4334 is a highly potent next-generation CAM with a potential best-in-class profile and has been specifically optimized to target both mechanisms.
In a Phase 1a study, once-daily oral dosing with ABI-4334 demonstrated a favorable safety and pharmacokinetic (PK) profile in healthy participants, with ABI-4334 exposure levels projected to achieve strong antiviral activity and double-digit multiples over protein adjusted EC50 for both HBV DNA replication and cccDNA formation. In vitro, ABI-4334 has shown single-digit nanomolar potency against both mechanisms of action and the ability to impact HBV DNA integration. The Phase 1b study that is currently enrolling will evaluate safety, PK and antiviral activity in individuals with cHBV infection over a 28-day treatment period.
“We believe ABI-4334 has the potential to demonstrate best-in-class antiviral activity in line with the very high potency seen preclinically and are pleased to initiate dosing for this differentiated investigational therapy in individuals with cHBV,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “In this 28-day placebo-controlled study, we will be able to measure the impact of escalating doses of ABI-4334 on HBV DNA and refine the projected activity against cccDNA formation, along with generating key safety data. We look forward to reporting interim results from the study later this year.”
About ABI-4334-102
ABI-4334-102 is a randomized, blinded and placebo-controlled dose-ranging Phase 1b study that will evaluate the safety, PK and antiviral activity of ABI-4334 in participants with cHBV infection.
Participants may be treatment-naïve or off-treatment and hepatitis B e antigen (HBeAg) positive or negative. The dose-escalation trial will enroll up to five sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 between ABI-4334 and placebo with a treatment period of 28 days.
The objectives of the study include assessments of safety, tolerability and PK for ABI-4334, as well as changes in HBV DNA associated with ABI-4334 treatment. The results of the trial will support dose selection for future clinical trials.
Additional information about the trial is available at clinicaltrials.gov using the identifier NCT06384131. ABI-4334 is an investigational product candidate that has not been approved anywhere globally, and its safety and efficacy have not been established.
About Assembly Biosciences
Assembly Biosciences is a biotechnology company dedicated to the development of innovative small molecule therapeutics designed to change the path of serious viral diseases and improve the lives of patients worldwide. Led by an accomplished team of leaders in virologic drug development, Assembly Bio is committed to improving outcomes for patients struggling with the serious, chronic impacts of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus (HDV) infections. For more information, visit assemblybio.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to materially differ. These risks and uncertainties include: Assembly Bio’s ability to realize the potential benefits of its collaboration with Gilead Sciences, Inc., including all financial aspects of the collaboration and equity investments; Assembly Bio’s ability to initiate and complete clinical studies involving its therapeutic product candidates, including studies contemplated by Assembly Bio’s collaboration with Gilead, in the currently anticipated timeframes or at all; safety and efficacy data from clinical or nonclinical studies may not warrant further development of Assembly Bio’s product candidates; clinical and nonclinical data presented at conferences may not differentiate Assembly Bio’s product candidates from other companies’ candidates; results of nonclinical studies may not be representative of disease behavior in a clinical setting and may not be predictive of the outcomes of clinical studies; and other risks identified from time to time in Assembly Bio’s reports filed with the U.S. Securities and Exchange Commission (the SEC). You are urged to consider statements that include the words may, will, would, could, should, might, believes, hopes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal or the negative of those words or other comparable words to be uncertain and forward-looking. Assembly Bio intends such forward-looking statements to be covered by the safe harbor provisions contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. More information about Assembly Bio’s risks and uncertainties are more fully detailed under the heading “Risk Factors” in Assembly Bio’s filings with the SEC, including its most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Except as required by law, Assembly Bio assumes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investor and Corporate:
Shannon Ryan
SVP, Investor Relations, Corporate Affairs and Alliance Management
(415) 738-2992
investor_relations@assemblybio.com
Media:
Sam Brown Inc.
Hannah Hurdle
(805) 338-4752
ASMBMedia@sambrown.com
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