Assembly Biosciences Reports Positive Interim Results for HSV-2 Treatment Studies
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 08 2025
0mins
Should l Buy GILD?
Assembly Biosciences announced interim results from two Phase 1b studies of its investigational long-acting herpes simplex virus helicase-primase inhibitors in participants seropositive for HSV type 2 with recurrent genital herpes. These interim results include the first reported Phase 1b data for ABI-1179, evaluating weekly oral dosing. For ABI-5366, the reported data is for a monthly oral dosing regimen, following the positive interim results for weekly oral dosing reported earlier this year. cohort. This reduction exceeds Assembly Bio's target for the study of an 80%-85% reduction in HSV-2 shedding rate. Further, data revealed a 91% reduction in virologically confirmed genital lesion rate compared to placebo with the 50 mg weekly dose. There was also a greater than 99% reduction in the number of samples with high viral load, a potential surrogate for HSV-2 transmission and a secondary endpoint. ABI-1179 was observed to be well-tolerated at oral doses up to 50 mg weekly and the observed pharmacokinetic profile continues to support once-weekly oral dosing regimens. In the ABI-5366 monthly dose cohort, potent antiviral activity was observed, with a 76% reduction in HSV-2 shedding rate compared to placebo over the 29-day evaluation period. The majority of positive swabs were collected in the last two weeks of the evaluation period when drug levels were declining. An 88% reduction in virologically confirmed genital lesion rate, along with an 81% reduction in the number of samples with high viral load compared to placebo, was observed. As previously reported for the 350 mg weekly dose cohort, a 94% reduction in HSV-2 shedding rate and a 97% reduction in virologically confirmed genital lesion rate compared to placebo was observed. ABI-5366 continues to be well-tolerated across all evaluated oral dosing regimens up to 350 mg weekly, and the PK profile supports both once-weekly and potentially once-monthly oral dosing regimens. Under the collaboration agreement between Assembly Bio and Gilead (GILD), Gilead has the right to opt in to an exclusive license for further development and commercialization of the helicase-primase inhibitor program, with the first option timepoint extending through the review of an option data package to be delivered by Assembly Bio following the end of the Phase 1b studies. ABI-1179 was contributed by Gilead under the collaboration between Assembly Bio and Gilead. ABI-5366 and ABI-1179 are investigational product candidates that have not been approved anywhere globally, and their safety and efficacy have not been established.
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Analyst Views on GILD
Wall Street analysts forecast GILD stock price to fall
19 Analyst Rating
16 Buy
3 Hold
0 Sell
Strong Buy
Current: 139.370
Low
105.00
Averages
137.88
High
154.00
Current: 139.370
Low
105.00
Averages
137.88
High
154.00
About GILD
Gilead Sciences, Inc. is a biopharmaceutical company. It is engaged in advancing medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer, and inflammation. It is focused on discovering, developing, and delivering medicines to address unmet medical needs in virology, oncology, and other therapeutic areas. Its portfolio of marketed products includes Biktarvy, Genvoya, Descovy, Complera/Eviplera, Symtuza, Truvada, Stribild, Sunlenca, Epclusa, Vemlidy, Harvoni, Viread, Livdelzi, Veklury, Yescarta, Tecartus, Trodelvy, AmBisome, and Letairis. Its product candidates include Bulevirtide, Lenacapavir, Axicabtagene ciloleucel, Sacituzumab govitecan-hziy, and others. It also develops the HB-400 program and the HB-500 program. It develops therapies that are intended to provide functional cures for hepatitis B virus and human immunodeficiency virus-1. It has a cancer program, namely TREX1. It operates in more than 35 countries worldwide.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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