Gilead Sciences Bets On Weekly Pill To Tackle Genital Herpes
Gilead Sciences, Inc. (NASDAQ:GILD) and Assembly Biosciences, Inc. (NASDAQ:ASMB) announced on Monday that Gilead has exercised its combined option to exclusively license Assembly Bio’s herpes simplex virus (HSV) helicase-primase inhibitor programs, including long-acting investigational candidates ABI-1179 and ABI-5366 for recurrent genital herpes.
These represent the first programs Gilead will advance under the ongoing Assembly Bio R&D collaboration. Genital herpes, caused by HSV, is a chronic infection that leads to painful lesions, psychological issues, and an increased risk of HIV acquisition.
Over four million people in the U.S. and major European countries experience recurrent genital herpes, with HSV type 2 (HSV-2) infections typically associated with multiple recurrences each year. No new therapies have been approved for HSV in the U.S. or Europe for more than 25 years.
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Early Clinical Data Shows Antiviral Activity
Interim Phase 1b data for ABI-5366 and ABI-1179 demonstrated antiviral activity and improvements in clinical outcomes, including a significant reduction in virus-positive lesions.
Both compounds also exhibit pharmacokinetic and safety profiles supportive of once-weekly oral dosing.
Financial Terms And Development Rights
Under the terms of the 2023 collaboration agreement between Gilead and Assembly Bio, Assembly Bio will receive a $35 million payment.
Gilead will have the sole right and responsibility for further clinical development and commercialization of these programs.
Assembly Bio remains eligible for up to $330 million in regulatory and commercial milestones, as well as tiered royalties on net sales.
Assembly Bio will also have the right to opt in to share 40% of all costs and profits in the United States instead of receiving milestones and royalties for that program in the United States after receipt of development plans and budgets from Gilead next year.
Separate Regulatory Win For HIV Prevention
On Friday, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) approved Gilead’s lenacapavir (Yeytuo) for the prevention of sexually transmitted HIV-1 infection in adults and adolescents.
Lenacapavir works by reducing the risk of the HIV-1 virus multiplying and spreading throughout the body if a person is exposed to the virus.
Lenacapavir is administered via a combination of tablets and injections. It is given as an injection once every six months. For the first dose only, people also take two days of tablets by mouth.
GILD Price Action: Gilead Sciences shares were down 0.22% at $124.02 at the time of publication on Monday, according to Benzinga Pro data.
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