Merck & Co., Inc. ( MRK Quick Quote MRK - Free Report) announced detailed data from two pivotal phase III studies — COUGH-1 and COUGH-2 — evaluating its oral selective P2X3 receptor antagonist, gefapixant (MK-7264), as a potential treatment for refractory or unexplained chronic cough. Data from the study showed that twice daily 45mg dose of gefapixant achieved statistically significant reduction in 24-hour cough frequency compared to placebo at 12-weeks. Detailed data from the studies were presented at the Virtual European Respiratory Society International Congress 2020.
Please note that refractory chronic cough is a situation wherein a patient’s cough persists even after receiving appropriate treatment of underlying conditions, while unexplained chronic cough is a situation where the underlying cause of cough cannot be identified despite a thorough evaluation.
The two phase III studies evaluated efficacy and safety of two twice daily doses — 15mg and 45mg — of gefapixant in patients with refractory or unexplained chronic cough. While the COUGH-1 study evaluated the candidate for 12 weeks, COUGH-2 study duration was 24 weeks.
Data from COUGH-1 showed 18.45% reduction in cough frequency compared to placebo at 12 weeks for the 45mg dose of gefapixant. The 45mg dose of the candidate achieved 14.64% reduction in cough frequency relative to placebo at 24-weeks in the COUGH-2 study. Reduction in cough frequency was 62% and 63% for the 45mg dose from baseline in COUGH-1 and COUGH-2 study, respectively.
The 45mg dosage of gefapixant also achieved statistical significance in awake cough frequency in COUGH-2 study by achieving an estimated relative reduction of 15.79%. In the COUGH-1 study, estimated relative reduction in awake cough frequency was 17.68%, which seemed trending toward significance. Moreover, significantly more participants in both studies experienced a clinically important level of improvement incough-related quality of life at week 24.
However, the 15mg dose of the candidate failed to meet primary endpoint of efficacy in both phase III studies.
Shares of Merck have lost 8.4% so far this year compared with the
industry’s decline of 0.9%.
Per the press release, there is a significant unmet need in the patient population with refractory or unexplained chronic cough. A potential new therapy will likely have strong demand.
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.
Zacks Rank & Key Picks
Merck currently carries a Zacks Rank #2 (Buy). Other stocks to consider in the healthcare sector include Horizon Therapeutics (
HZNP Quick Quote HZNP - Free Report) , Pulmatrix, Inc. ( PULM Quick Quote PULM - Free Report) and Catalent, Inc. ( CTLT Quick Quote CTLT - Free Report) . While Horizon Therapeutics sports a Zacks Rank #1 (Strong Buy), Pulmatrix and Catalent carry a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
Horizon Therapeutics’ earnings estimates have been revised 19.2% upward for 2020 and 17.9% upward for 2021 over the past 30 days. The stock has rallied 97.6% so far this year.
Pulmatrix’s loss estimates have narrowed 43% for 2020 and 30.6% for 2021 over the past 30 days.
Catalent earnings estimates have been revised 9.2% upward for 2021 and 9.8% upward for 2022 over the past 30 days.
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