With Competitor Out, New Drug Gains Edge in Chronic Cough
Research Report

Trevi Therapeutics Inc.'s (TRVI:NASDAQ) investigational therapeutic Haduvio became "one of the more promising players" in the chronic cough space recently when Merck & Co. Inc. (MRK:NYSE) took gefapixant out of the running, reported D. Boral Capital Analyst Jason Kolbert in a March 7 research note.

"Merck's decision to abandon gefapixant removes a key competitor from the market, further positioning Haduvio as a potential leading therapy for chronic cough," Kolbert wrote.

Potential Gain of 389%

D. Boral maintained its $21 per share target price on Trevi, now trading at about $4.29 per share, noted Kolbert. The target suggests return potential of 389%.

The biopharma remains a Buy.

Trevi's average daily volume is 716,000. Its market cap is $383 million.

Efficacy Not Proven

Merck had intended for gefapixant, a P2X3 receptor antagonist, to be a non-narcotic treatment for chronic cough but withdrew the new drug application for it after receiving a second Complete Response Letter from the U.S. Food and Drug Administration (FDA), Kolbert relayed. The agency indicated it could not approve gefapixant because insufficient evidence of the drug's efficacy had been provided.

Haduvio's Differentiators

Kolbert presented some of the ways Haduvio differentiates itself from gefapixant. Haduvio is an oral, extended-release formulation of nalbuphine that Trevi is advancing for chronic cough in idiopathic pulmonary fibrosis as well as refractory chronic cough. Unlike gefapixant, Haduvio's mechanism of action is direct, and it targets the central and peripheral nervous systems.

Also unlike gefapixant, Haduvio has shown safety and proof of concept in clinical trials. It has shown "meaningful clinical benefit" in reducing frequency of chronic cough, particularly in idiopathic pulmonary fibrosis patients. An effective treatment for this indication in this patient population is a significant unmet need.

Kolbert pointed out that Merck's withdrawal of gefapixant highlights how hard it is to develop effective treatments for chronic cough and how strict the regulatory requirements are for drug approval. When it comes to Haduvio, though, he noted, it is based on nalbuphine, a well-characterized molecule with a known safety profile. This significantly reduces the risk inherent in developing novel compounds.

Critical Near-Term Milestone

Kolbert reported that topline data are coming soon for two clinical trials evaluating Haduvio in chronic cough. Trevi's Phase 2a RIVER study in patients with refractory chronic cough is due to read out this quarter.

Trevi's Phase 2b CORAL trial in patients with chronic cough related to idiopathic pulmonary fibrosis are anticipated in H1/25.

"Positive data could reinforce the drug's differentiation and support its progression into late-stage development," Kolbert wrote. "They could validate Haduvio's potential as a nove therapeutic option in a field with limited alternatives."

The outcomes of these trials are even more pivotal, both patients and investors, Kolbert wrote, now that gefapixant is out of the picture, and the path to FDA approval is clearer.