Merck & Co., Inc. MRK announced encouraging top-line efficacy data from two pivotal phase III studies, which evaluated the safety and efficacy of its pipeline candidate gefapixant (MK-7264) for the treatment of refractory or unexplained chronic cough.
The double-blind, placebo-controlled phase III studies (COUGH-1 and COUGH-2) evaluated the efficacy and safety of gefapixant, an investigational, orally administered, selective P2X3 receptor antagonist, in reducing cough frequency in adult patients with refractory or unexplained chronic cough. Currently, there are no approved therapies for the given indication.
According to the company, chronic cough is estimated to affect about 10% of adults in the world.
In both the studies gefapixant (45 mg twice daily) met the primary efficacy endpoints by demonstrating a statistically significant decrease in 24-hour coughs per hour versus placebo at 12 weeks (COUGH-1) and 24 weeks (COUGH-2) of treatment.
However, the arms evaluating the 15 mg twice daily dose did not meet the primary efficacy endpoint in either of the two studies.
Per the company, until now, the safety and tolerability profile of gefapixant has been consistent with the previously provided data from the phase II study. The studies will continue for a long-term follow-up to collect additional safety data.
Shares of Merck have lost 9% in the past year compared with the industry’s decline of 12.6%.
We remind investors that gefapixant was added to Merck’s portfolio following the acquisition of Afferent Pharmaceuticals in July 2016. The candidate is also being evaluated in a phase II study for the treatment of women with endometriosis-related pain.
Meanwhile, Merck is tapping external sources in order to build its long-term portfolio. The company inked several licensing deals in the past few years and targets more such deals in the future.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Regeneron Pharmaceuticals, Inc. REGN, Pfizer Inc. PFE and AbbVie Inc. ABBV. While Regeneron sports a Zacks Rank #1 (Strong Buy), Pfizer and AbbVie carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised 8.4% upward for 2020 over the past 60 days. The stock has rallied 20.8% in the past year.
Pfizer’s earnings estimates have moved 4.8% north for 2020 over the past 60 days.
AbbVie earnings estimates have been revised 2% upward for 2020 over the past 60 days.
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