Assembly Biosciences Presents New Preclinical Data Highlighting Investigational Helicase-Primase Inhibitors at International Herpesvirus Workshop
Assembly Biosciences (Nasdaq: ASMB) presented new preclinical data on its investigational helicase-primase inhibitors for recurrent genital herpes at the International Herpesvirus Workshop. The company highlighted promising results for two candidates: ABI-5366 and ABI-1179.
Key findings for ABI-5366 include low nanomolar activity against HSV-1 and HSV-2, specificity for HSV, and a favorable safety profile. The Phase 1a/b study for ABI-5366 began in May 2024, with interim Phase 1a data expected in Q3 2024.
ABI-1179, licensed from Gilead Sciences, demonstrated potent activity against HSV strains, including acyclovir-resistant isolates, and showed potential for once-weekly oral dosing. Assembly Bio plans to initiate a Phase 1a/b study for ABI-1179 by the end of 2024.
- ABI-5366 showed low nanomolar activity against both HSV-1 and HSV-2
- ABI-5366 demonstrated a favorable in vivo safety profile in 28-day oral toxicity studies
- Phase 1a/b study for ABI-5366 initiated in May 2024
- ABI-1179 displayed a higher barrier to resistance development than acyclovir
- ABI-1179 demonstrated potential for once-weekly oral dosing
- ABI-1179 significantly reduced the development of recurrent lesions in a preclinical model
- None.
Insights
Assembly Bio's new preclinical data on ABI-5366 and ABI-1179 is significant for those following developments in the treatment of recurrent herpes. Both compounds target the HSV helicase-primase complex, an enzyme critical to the virus. This mechanism is promising as it differs from the current standard of care, nucleoside analogs, which only partially prevent recurrences. Notably, ABI-5366 demonstrated low nanomolar activity against HSV-1 and HSV-2 and a favorable safety profile in preclinical studies, supporting its current Phase 1 clinical trial. ABI-1179 also showed compelling preclinical results, including activity against acyclovir-resistant strains and a high barrier to resistance.
For retail investors, the potential shift to more effective treatments for recurrent herpes is notable, particularly if these candidates can offer better management of symptoms and fewer recurrences. However, the compounds are still in early-stage trials and their eventual success is uncertain until clinical efficacy and safety are confirmed in humans.
The development of ABI-5366 and ABI-1179 could potentially capture a significant share of the herpes treatment market if clinical trials are successful. Current treatments are insufficient for many patients, creating a strong demand for more effective options. The market for recurrent genital herpes treatments is sizable given the prevalence of HSV, with over four million affected individuals in key markets like the US and Europe. If Assembly Bio's candidates prove effective, they could potentially disrupt the existing market dominated by nucleoside analogs.
Moreover, the collaboration with Gilead Sciences for ABI-1179 adds credibility and resources, potentially accelerating development and market entry. Investors should watch for the upcoming Phase 1a and 1b trial results, which will be critical in assessing the viability of these treatments.
– Data from both ABI-5366 and ABI-1179, novel long-acting helicase-primase inhibitor candidates for recurrent genital herpes, to be presented –
– Poster presentation highlights key preclinical data from ABI-5366 supporting its entry into ongoing Phase 1a/b clinical trials –
– Oral and poster presentations feature first data presented from ABI-1179, expected to enter the clinic by the end of 2024 –
SOUTH SAN FRANCISCO, Calif., July 15, 2024 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral diseases, today announced new preclinical data from its investigational herpes simplex virus (HSV) portfolio featured in three presentations at the International Herpesvirus Workshop (IHW), taking place July 13-17, 2024, in Portland, Ore.
“We are excited to present promising data from our HSV helicase-primase inhibitor candidates ABI-5366 and ABI-1179, which we are rapidly progressing to deliver on our mission of offering new, effective treatments for people living with chronic viral diseases,” said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio. “Current treatments for recurrent genital herpes often fall short in fully managing symptoms and preventing recurrences, and we are pleased with the potential of our HSV candidates to provide a different approach, as highlighted in the data presented at IHW. We continue to advance these candidates and look forward to sharing further updates with the herpesvirus community, including interim ABI-5366 Phase 1a first-in-human data expected in the third quarter of this year.”
Approximately
A poster entitled “The Helicase-Primase Inhibitor ABI-5366 Is a Novel, Potent, Long-Acting Inhibitor for the Treatment of Recurrent Genital Herpes” highlights preclinical data that supported ABI-5366’s entry into Phase 1 clinical evaluation. Results demonstrated that ABI-5366 showed low nanomolar activity against both HSV-1 and HSV-2, including broad activity against HSV clinical isolates, and specificity for HSV. ABI-5366 was shown to be generally non-toxic across a variety of cell types with no off-target effects observed in vitro or in vivo, including no activity against carbonic anhydrase esterases. Further, a favorable in vivo safety profile of ABI-5366 was observed in 28-day oral toxicity studies in two species, and pharmacokinetic (PK) studies evaluating ABI-5366 when administered orally or intramuscularly demonstrated long-acting potential for this compound. The Phase 1a/b study for ABI-5366 was initiated in May 2024 and is currently enrolling; interim Phase 1a data are expected in Q3 2024 and interim Phase 1b data are expected in the first half of 2025.
Additionally, an oral and poster presentation entitled “Preclinical Characterization of ABI-1179, a Potent Helicase Primase Inhibitor for the Treatment of Recurrent Genital Herpes” features preclinical data from ABI-1179, a structurally distinct, long-acting helicase-primase inhibitor candidate, licensed from Gilead Sciences, Inc. (Gilead) under the collaboration between Assembly Bio and Gilead. ABI-1179 has demonstrated low nanomolar activity across HSV-1 and HSV-2 lab strains and clinical isolates, including acyclovir-resistant isolates. In resistance selection studies, ABI-1179 displayed a higher barrier to resistance development than acyclovir. Furthermore, ABI-1179 demonstrated antiviral activity against some HSV-2 strains harboring mutations known to confer resistance to other helicase-primase inhibitors. In a preclinical study, ABI-1179 demonstrated a favorable PK profile that supports the evaluation of once-weekly oral dosing. Further, in a preclinical model of recurrent HSV infection, ABI-1179 significantly reduced the development of recurrent lesions. Assembly Bio expects to initiate a Phase 1a/b first-in-human study of ABI-1179 by the end of 2024.
Assembly Bio intends to make the presentations available on the “Events & Presentations” page in the “Investors” section of its website at www.assemblybio.com. The investigational product candidates ABI-5366 and ABI-1179 have not been approved anywhere globally, and their 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
FAQ
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