Assembly Biosciences NASDAQ: ASMB Chief Medical Officer Anuj Gaggar outlined the company’s virology strategy and upcoming clinical priorities during a Bank of America-hosted discussion, emphasizing programs in herpes simplex virus, hepatitis D and transplant-related herpes viruses.
Gaggar described Assembly as a clinical-stage research and development company focused on serious viral illnesses where patients still lack adequate treatment options. He said the company has a broad partnership with Gilead Sciences and has advanced four new molecules into the clinic over the past two and a half years, generating what he characterized as positive data across those programs.
Most recently, Gaggar said, Gilead optioned Assembly’s two HSV programs based on Phase 1b data. “We’re excited for the next year where we’ll move our other programs into value inflection points as well,” he said.
Assembly Sees Continued Unmet Need in HSV, Hepatitis B and Hepatitis D
Asked whether areas such as hepatitis B, hepatitis D and HSV still support meaningful innovation despite existing vaccines and antivirals, Gaggar said “absolutely.” He noted that HSV currently has no approved prophylactic or therapeutic vaccine, and said recent HSV-2 vaccine trials from GSK and Moderna did not meet their endpoints.
In antivirals, Gaggar said existing HSV treatments still leave room for improvement. He said more than two-thirds of patients fail on chronic suppressive therapy for HSV-2, adding that current options do not adequately address the full patient burden.
For hepatitis B and hepatitis D, Gaggar pointed to the availability of a prophylactic hepatitis B vaccine, but said there remain millions of people globally who already have infection. He said there are no effective therapies for curing hepatitis B and limited options for hepatitis D outside bulevirtide, which he noted is approved in the European Union.
HSV Program Focuses on Lesions, Convenience and Transmission
Gaggar said Assembly evaluates clinically meaningful outcomes in recurrent genital herpes across three areas: lesion reduction, treatment convenience and transmission risk. He said lesions are painful and psychologically impactful, with some patients experiencing multiple outbreaks per year or even monthly episodes.
He contrasted Assembly’s approach with valacyclovir, which he described as limited by lower potency and pharmacokinetics that require daily dosing for suppressive therapy. Gaggar said longer-acting treatments could improve adherence and efficacy, drawing a comparison to progress in HIV therapy.
Transmission is another key consideration, he said, because patients are often concerned about passing HSV to sexual partners. Gaggar said high viral levels and frequent viral shedding drive transmission risk, and that treatments reducing shedding could be meaningful for patients.
Gaggar said Assembly’s 1179 and 5366 molecules, now in-licensed by Gilead, are “highly potent weekly dose medicines” that were well tolerated and could address lesions, convenience and transmission.
He added that both Gilead and Assembly had independently identified the helicase-primase inhibitor target before their collaboration. Gaggar said the companies viewed the target as attractive because there is no comparable host equivalent and because it can support highly potent antiviral molecules. He said Phase 1b data exceeded Assembly’s expectations across lesion reduction, shedding reduction and high viral-load shedding reduction.
Hepatitis D Program Targets Oral NTCP Inhibition
Assembly is also developing 6250, an oral small molecule targeting NTCP for hepatitis D. Gaggar said the program benefits from clinical validation of the NTCP target through Gilead’s bulevirtide, a peptide therapy approved in the EU. He said Assembly expects U.S. approval of bulevirtide “soon,” while noting that bulevirtide has multiple years of safety and efficacy data.
Gaggar said Assembly’s Phase 1a study of 6250 showed safety, pharmacokinetics and a dose-dependent increase in serum bile acids, a pharmacodynamic marker of NTCP engagement. He said the bile acid increases were equal to and even greater than what was seen with bulevirtide.
“For us, that’s a very de-risking Phase 1a study that lets us go straight to a Phase 2 program,” Gaggar said. He said Assembly plans to begin those studies by the end of this year after accelerating chronic toxicology work to support longer-term dosing in hepatitis D patients.
The company expects data readouts by the end of 2027, with the goal of identifying a dose level to take into Phase 3, subject to regulator discussions. Gaggar said Assembly is designing the Phase 2 trial to support moving directly into Phase 3 afterward.
Gaggar said 6250’s potential differentiation could come from oral convenience as well as consistent drug levels over time. He noted that other hepatitis D approaches include daily injectable bulevirtide, potential weekly or monthly injectables from Mirum and monthly injectable combinations from Vir. Because hepatitis D patients are already taking daily pills for hepatitis B, Gaggar said adding an oral hepatitis D drug could be the simplest approach for patients if efficacy is similar.
Company Awaits Gilead Development Plans for HSV
Looking across the portfolio, Gaggar said early-stage antiviral data often track with later-stage studies, and Assembly designs early trials to de-risk later development. He said the HSV-2 Phase 1b studies helped de-risk efficacy and safety, though longer dosing and larger patient numbers will increase confidence in safety.
For the HSV-2 programs, Gaggar said Assembly is awaiting Gilead’s development plan. Once received, Assembly could opt in to a 40% profit and cost share, which Gaggar said would allow the company to capture more value from its prior work on the programs.
Gaggar also said there may be additional HSV market opportunities beyond recurrent genital herpes, including subcutaneous injections every three months, monthly oral therapy, oral herpes and other areas where the molecules could potentially affect patient outcomes.
Transplant-Related Viruses Remain an Area of Interest
Beyond its current focus areas, Gaggar highlighted ABI-7272, a program aimed at transplant-related herpes viruses. He said the transplant setting is becoming increasingly important as more transplants are performed and more patients live with immunosuppression.
Gaggar specifically identified cytomegalovirus, or CMV, as an area Assembly finds “very exciting,” and said ABI-7272 is a “fantastic molecule” the company believes could be useful. He added that Assembly continues to maintain an active research group and hopes to potentially announce another candidate later this year.
About Assembly Biosciences NASDAQ: ASMB
Assembly Biosciences, Inc NASDAQ: ASMB is a clinical-stage biotechnology company dedicated to the discovery, development and commercialization of novel therapies for hepatitis B virus (HBV) and hepatitis D virus (HDV) infections. The company's core expertise lies in small-molecule modulation of viral proteins and host-targeted pathways to achieve sustained viral suppression and potential functional cure. Assembly's research model integrates medicinal chemistry, structural biology and translational virology to advance its pipeline from early discovery through clinical development.
The company's lead programs include core protein allosteric modulators (CpAMs) designed to disrupt the HBV lifecycle by interfering with capsid assembly and viral DNA replication, as well as prenylation inhibitors targeting the HDV lifecycle.
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