MRK's Pivotal Study on Two-Drug, Once-Daily HIV Pill Meets Goals

Merck MRK announced positive topline data from two pivotal phase III studies evaluating the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) in virologically suppressed adults with HIV-1 infection.The phase III MK-8591A-051 and MK-8591A-052 studies evaluated DOR/ISL (100 mg/0.25 mg) in adults with HIV-1 infection who are on different antiretroviral therapy regimens like baseline antiretroviral therapy and bictegravir/emtricitabine/tenofovir alafenamide, respectively.Data from both studies showed that treatment with DOR/ISL demonstrated non-inferiority versus comparator antiretroviral therapies in adults with virologically suppressed HIV-1, the success criteria for the primary efficacy hypothesis.However, the MK-8591A-052 study failed to meet the superiority criteria, but both studies met the primary safety objectives.Year to date, shares of Merck have declined 8.8% against the industry’s growth of 4.4%.Image Source: Zacks Investment ResearchMore on MRK's HIV-1 ProgramBesides MK-8591A-051 and MK-8591A-052 studies, two other ongoing phase III studies are evaluating DOR/ISL for the treatment of HIV-1.The MK-8591A-053 study is evaluating DOR/ISL in treatment-naïve people with HIV and the MK-8591A-054 is evaluating open-label DOR/ISL in people who participated in earlier phase III studies on the two-drug, single-tablet regimen of DOR/ISL.In the United States, doravirine in combination with other antiretrovirals and as a single agent is approved under the trade name Pifeltro for treating adults with HIV-1. It is also approved as a component of a single-tablet regimen under the trade name Delstrigo for treating HIV-1.Islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, is currently being evaluated in multiple studies in combination with other antiretroviral therapies for the treatment of HIV-1.Merck decided to evaluate a lower dose of its HIV candidate islatravir in a phase III program several months after the FDA put studies on the candidate on hold last year. While six studies on islatravir were placed on full clinical hold, seven were put on partial clinical hold. Now the new phase III studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of islatravir (DOR/ISL).Recent Updates on MRK's IslatravirMerck along with partner Gilead Sciences GILD is evaluating the investigational combination of islatravir and the latter’s, first-in-class HIV-1 capsid inhibitor, lenacapavir, in a phase II study for the treatment of HIV.New data, announced in October 2024, showed that a treatment switch to an investigational oral once-weekly combination regimen of MRK’s islatravir and GILD’s lenacapavir maintained viral suppression in adults at week 48.Lenacapavir is approved under the brand name Sunlenca in the United States for treating HIV-1 infection in heavily treatment-experienced adults with multi-drug-resistant infections.GILD also markets Biktarvy, as a once-a-day single tablet, to treat HIV-1 in adults and children.Gilead is a dominant player in the HIV market. The company developed the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis to help reduce new HIV infections and the first long-acting injectable HIV treatment medication administered twice yearly.MRK's Zacks Rank & Key PicksMerck currently carries a Zacks Rank #3 (Hold).Some better-ranked stocks from the biotech sector are Castle Biosciences, Inc. CSTL and Spero Therapeutics, Inc. SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.In the past 60 days, estimates for Castle Biosciences’ 2024 bottom line have moved from a loss of 59 cents to earnings of 34 cents. Loss per share estimates for 2025 have narrowed from $2.15 to $1.84 during the same time. Year to date, shares of CSTL have surged 25.5%.CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. During the same time, estimates for 2025 loss per share have narrowed from $1.54 to 79 cents. Year to date, shares of SPRO have lost 32.%.SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.Zacks Names #1 Semiconductor StockIt's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.See This Stock Now for Free >>Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Merck & Co., Inc. (MRK): Free Stock Analysis Report Gilead Sciences, Inc. (GILD): Free Stock Analysis Report Spero Therapeutics, Inc. (SPRO): Free Stock Analysis Report Castle Biosciences, Inc. (CSTL): Free Stock Analysis ReportTo read this article on Zacks.com click here.Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks