Results from the company’s Phase IIa double-blind, placebo-controlled River trial (NCT05962151) saw the oral therapy meeting both its primary endpoint. Credit: Shutterstock / Drazen Zigic.
Trevi Therapeutics’ stock value has shot up more than 53% after its investigational therapy Haduvio (nalbuphine hydrochloride) reduced the frequency of coughing fits by 57% compared to placebo in patients with chronic cough resulting from idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
Results from the company’s Phase IIa double-blind, placebo-controlled River trial (NCT05962151) saw the oral therapy meeting its primary endpoint in reducing cough frequency over a 24-hour period, with clinical effects noticed at the lowest dose range.
Following the announcement, the company’s stock value spiked more than 71.86%, up from a 7 March close of $4.30 per share to a 10 March high of $7.39 following the announcement.
Shorthand for ‘Refractory Chronic Cough Improvement Via Nalbuphine ER’, the River trial saw patients dosed with Haduvio for 21 days followed by a 21-day washout period. Patients received either 27mg twice-daily, 54mg or 108mg.
The company has now said that its next steps will be to discuss a future Phase III trial with the US Food and Drug Administration (FDA).
Trevi chief development officer James Cassella said: “The results from the River trial were highly statistically significant with consistent outcomes across the primary and analysed secondary endpoints as well as for patients with moderate or severe baseline cough frequency.
“We look forward to advancing the development of Haduvio in the hopes of providing relief for the significant unmet need of these chronic cough patients. Based on these results, we plan to discuss the next steps with the FDA and anticipate initiating the next study after we receive their input.”
Currently in the US, there are no currently available therapies specifically for RCC. This is usually defined as a persistent cough lasting longer than eight weeks and is typically associated with another underlying condition such as asthma or eosinophilic bronchitis.
A 2021 study published in the Journal of Allergy and Clinical Immunology in Practice polled approximately 75,000 Americans finding that 3,654 had experienced chronic cough in the previous 12 months, for a weighted prevalence of 5.0%. The same survey also found that Respondents with chronic coughs were likely to be older and predominantly female.
In the case that the therapy makes it to market, research by GlobalData estimates that by the end of 2027, Haduvio is likely to bring in $31m for the US company.
Trevi CEO Jennifer Good said: “The River trial demonstrated that Haduvio was highly effective, and worked quickly at the lowest dose tested across a broad range of cough counts. These results, coupled with our existing IPF chronic cough results, are further evidence of the effectiveness of Haduvio’s central and peripheral KAMA mechanism in treating these difficult neurological cough conditions which are so disruptive to patients’ lives.”
Elsewhere in the field of IPF, Pliant Therapeutics has terminated a Phase IIb trial of bexotegrast amid safety concerns, sending the company’s stock price spiralling. Meanwhile, Boehringer Ingelheim’s lung disease drug nerandomilast has been successful in a Phase III study.
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