NEW HAVEN -
RCC affects up to 10% of adults worldwide and is defined by a cough that lasts >8weeks and does not respond to therapy for an underlying condition. Topline data from the RIVER trial is expected in the second half of 2024.
'We are excited about the initiation of the RIVER study in refractory chronic cough,' said
Phase 2a Trial Design: Refractory Chronic Cough Improvement Via
The RIVER trial is a double-blind, randomized, placebo-controlled, 2-period crossover study evaluating the safety and efficacy of Haduvio in reducing chronic cough in RCC subjects. Approximately 60 RCC subjects are expected to be randomized with a 1:1 stratification between those with 10-19 coughs/hour (moderate 24-hour cough frequency) and those with 20 coughs/hour (high 24-hour cough frequency). Each treatment period will last 21 days, separated by a 21-day washout period, and subjects on Haduvio will have the dose titrated from 27 mg once a day (QD) up to 108 mg twice a day (BID) across the 21-day dosing period.
The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at Day 21 from treatment period baseline for Haduvio compared to placebo, as measured via an objective cough monitor. The study will also explore secondary endpoints, including patient reported outcome measures for cough and dyspnea.
About Refractory Chronic Cough (RCC)
Refractory chronic cough affects up to 10% of the adult population and is defined as a persistent cough lasting >8weeks, despite treatment for an underlying condition. RCC is caused by cough reflex hypersensitivity in the central and peripheral nerves. It is highly disruptive and accompanied by a wide range of complications, ranging from urinary incontinence in females to sleep disruption and social embarrassment that causes significant social and economic burden for patients and those around them.
The most common causes of RCC are asthma, gastroesophageal reflux disease (GERD), non-asthmatic eosinophilic bronchitis, and upper airway cough syndrome or post-nasal drip. There are no approved therapies for RCC in the
About
The impact of chronic cough is significant and often leads to a decline in patients' social, physical, and psychological quality of life. There are no approved therapies for the treatment of chronic cough in IPF and current treatment options provide minimal relief to patients. In IPF, chronic cough may lead to worsening disease and may be associated with a higher risk of progression, death, or need for lung transplant.
Parenteral nalbuphine is not scheduled by the
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials, and other statements containing the words 'believes,' 'anticipates,' 'plans,' 'expects,' and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success and timing of Trevi's product candidate development activities and ongoing and planned clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of future clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in
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