Shares of Trevi Therapeutics TRVI surged 41% yesterday after it reported positive top-line data from the phase IIa RIVER study evaluating its investigational therapy Haduvio as a potential treatment for refractory chronic cough (RCC).

The study met its primary endpoint — treatment with Haduvio achieved a statistically significant reduction in the 24-hour cough frequency by 67% from baseline and 57% on a placebo-adjusted basis. Similar efficacy was also seen in Haduvio-treated patients when categorized across severity levels, with a 66% reduction in 24-hour cough frequency in patients with severe cough (≥20 coughs/hour) and a 68% reduction in those with moderate cough (10-19 coughs/hour). These results reinforce the drug’s potential as a broad treatment option, effectively reducing cough frequency regardless of baseline severity.

Haduvio also demonstrated a strong treatment response, with 84% of patients achieving at least a 30% reduction in 24-hour cough frequency from baseline compared with 29% in the placebo group.

Haduvio’s safety profile was also consistent with results from the previously conducted studies. Trevi is also conducting the phase IIb CORAL study, which is evaluating the drug in idiopathic pulmonary fibrosis (IPF) patients with chronic cough. Data from this study is expected in the first half of 2025.

TRVI Stock Performance

The above results impressed Wall Street since the efficacy results exceeded the expectations of several analysts. Per Trevi, the RIVER study results make Haduvio the first and only therapy to show a statistically significant reduction in chronic cough across both RCC and IPF patients.

Chronic cough is defined as a cough lasting longer than eight weeks. RCC is a cough that persists despite appropriate treatment of underlying conditions, such as asthma or gastroesophageal reflux disease.

Currently, there are no approved treatments for RCC indication in the United States. Trevi expects that the drug’s potential approval could cater to a broad patient population. The company estimates that about 2-3 million people living in the country are affected by RCC.

Year to date, TRVI shares have surged more than 47% compared with the industry’s 7% growth.

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Other Players Developing Drugs for RCC

Apart from Trevi, GSK plc GSK is evaluating its own investigational chronic cough drug in late-stage development. The drug named camlipixant was added by GSK after it acquired Bellus Health in 2023. GSK expects to launch its RCC drug commercially in 2026.

Another company that was once ahead in the RCC drug race was Merck MRK, whose chronic cough drug, gefapixant, received two complete response letters (CRL) from the FDA. While the agency issued the first CRL in 2022 requesting Merck to submit additional information regarding the drug’s efficacy, the second CRL was issued in 2023, which concluded that the data submitted by Merck did not provide sufficient evidence proving the drug’s clinical benefit. After receiving the second CRL, Merck decided to end this drug’s development.

Trevi Therapeutics, Inc. Price

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TRVI’s Zacks Rank

Trevi currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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