RAHWAY, N.J. - Merck (NS:PROR) & Co., Inc. (NYSE: MRK) has announced positive results from two pivotal Phase 3 trials for its investigational HIV-1 treatment regimen, doravirine/islatravir (DOR/ISL). The trials compared DOR/ISL to current antiretroviral therapies and met primary efficacy endpoints, confirming non-inferiority in maintaining virologic suppression.
The trials, known as MK-8591A-051 and MK-8591A-052, evaluated the efficacy and safety of switching to DOR/ISL from baseline antiretroviral therapy (bART) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in adults with suppressed HIV-1. At Week 48, both studies achieved the primary efficacy goal, with participants maintaining HIV-1 RNA levels below 50 copies/mL, indicating that DOR/ISL is non-inferior to the comparator therapies. Superiority criteria, however, were not met in the MK-8591A-052 trial.
Safety profiles for DOR/ISL were generally comparable to those of the other therapies involved in the trials. Merck plans to present more detailed findings from these studies at a future scientific congress and intends to submit the data to regulatory authorities.
Dr. Eliav Barr, senior vice president at Merck Research Laboratories, expressed optimism about the results, stating they are committed to advancing their clinical programs for islatravir as potential options to address the needs of people living with HIV. The company's robust research initiatives are supported by its strong financial health, earning a "GREAT" overall score from InvestingPro's comprehensive analysis, which evaluates multiple financial metrics and growth indicators.
Islatravir (MK-8591) is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in various clinical trials. The drug is designed to inhibit both transcriptase and translocation, which prevents nucleotide binding and incorporation into DNA, resulting in immediate chain termination.
The current U.S. indications for doravirine, as a single agent (PIFELTRO) and part of a single-tablet regimen (DELSTRIGO), are for the treatment of adults with HIV-1 in combination with other antiretrovirals.
Further safety information and contraindications, particularly regarding posttreatment acute exacerbation of hepatitis B and drug interactions, are detailed in the prescribing information for both PIFELTRO and DELSTRIGO.
Merck, a leading global biopharmaceutical company, has a longstanding commitment to HIV research and treatment development. The company has maintained dividend payments for 54 consecutive years and raised them for 14 straight years, demonstrating consistent financial stability. InvestingPro analysis suggests the stock is currently undervalued, with analysts maintaining positive growth forecasts for this year. For detailed insights into Merck's financial health and growth prospects, investors can access the comprehensive Pro Research Report, available among 1,400+ top stocks on InvestingPro. This news is based on a press release statement.
In other recent news, Merck & Co., Inc. has maintained its Outperform rating from BMO Capital following strategic moves to diversify its portfolio. Merck recently entered the obesity treatment market by in-licensing a preclinical oral small molecule, GLP-1RA HS-10535, from Hansoh Pharma. The deal involved an upfront payment of $112 million, with potential milestone payments reaching up to $1.9 billion. Bernstein SocGen Group also maintained its Market Perform rating for Merck, despite the company's decision to halt two oncology programs, KeyVibe and KeyForm. Merck's third-quarter revenue for 2024 saw a 4% increase, reaching $16.7 billion, driven by strong sales of its cancer drug KEYTRUDA and the introduction of WINREVAIR. These recent developments reflect Merck's proactive approach to expanding its pipeline and its continuous efforts in research and development.
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