Assembly Bio reports 94% reduction in HSV-2 shedding with new drug

SOUTH SAN FRANCISCO - Assembly Biosciences, Inc. (NASDAQ:ASMB), whose stock has surged over 58% in the past year according to InvestingPro data, announced Friday positive interim results from a Phase 1b study of its investigational herpes simplex virus (HSV) treatment ABI-5366, showing significant reductions in viral shedding and genital lesions in patients with recurrent genital herpes.

The study demonstrated a 94% reduction in HSV-2 shedding rate compared to placebo (p

The drug was well-tolerated at oral doses up to 350 mg weekly, with no serious adverse events reported. The pharmacokinetic profile supports once-weekly dosing and potentially once-monthly oral dosing regimens.

"These results underscore our conviction in the potential for ABI-5366 to reduce outbreaks and improve quality of life for those affected by the severe impacts of recurrent genital herpes," said Anuj Gaggar, MD, PhD, chief medical officer of Assembly Bio, in the press release.

Assembly Bio plans to move directly into Phase 2 clinical study preparation, with initiation expected in mid-2026. The company is also conducting a concurrent Phase 1b study of another HSV helicase-primase inhibitor candidate, ABI-1179, with interim data expected this fall.

Under a collaboration agreement, Gilead Sciences has the option to license the helicase-primase inhibitor program after reviewing data from the completed Phase 1b studies.

Recurrent genital herpes affects over four million people in the U.S. and major European countries, with most patients experiencing three or more recurrences per year. No new drugs have been approved for genital herpes in the United States or Europe in more than 25 years. With the stock trading near its 52-week high and analysts setting price targets between $29 and $31, InvestingPro subscribers can access 12 additional exclusive tips about Assembly Bio’s market position and growth potential.

In other recent news, Assembly Biosciences announced positive topline results from its Phase 1b study of ABI-4334, a drug for chronic hepatitis B virus infection. The 28-day trial revealed significant reductions in HBV DNA levels, with a mean decrease of 2.9 log10 IU/mL in the 150 mg dosage cohort and 3.2 log10 IU/mL in the 400 mg cohort. Participants with detectable HBV RNA at baseline also experienced declines of 2.5 and 2.3 log10 U/mL, respectively. Additionally, Assembly Biosciences made several key changes following its Annual Meeting of Stockholders. The company expanded its stock incentive plans, increasing the number of shares reserved for issuance. Amendments to the 2018 Stock Incentive Plan and the Employee Stock Purchase Plan were approved, raising the shares reserved to 1,478,333 and 225,000, respectively. These developments are part of a broader strategy to support a supplemental retention grant program. Furthermore, Assembly Biosciences appointed a new Chief Financial Officer to strengthen its leadership team.

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