Trevi Therapeutics, Inc. Discusses Progress and 2022 Success of Clinical Studies for Its Investigational Oral Therapy Haduvio(TM) with The Stock Day Podcast
Phoenix, Arizona–(Newsfile Corp. – January 25, 2023) – The Stock Day Podcast welcomed Trevi Therapeutics, Inc. (NASDAQ: TRVI) (“the Company”), a clinical-stage biopharmaceutical company developing the investigational oral therapy Haduvio™ (nalbuphine ER) for the treatment of chronic cough in adults with IPF, other chronic cough indications, and for the treatment of prurigo nodularis. President and CEO of the Company, Jennifer Good, joined Stock Day host Everett Jolly.
Jolly began the interview by asking about the Company’s background and current projects. “We started this company back in 2010 to explore the broad mechanism around a drug called nalbuphine ER,” shared Good, adding that she is also one of the Co-Founders of the Company. “We have been looking at difficult to treat conditions that all have some interconnectivity,” she explained. “Our path forward here is through severe chronic cough, which is also linked to some tough diseases.”
Jolly then asked for an update on the Company’s Phase 2 CANAL trial of its investigational oral therapy Haduvio™ in chronic cough in IPF. “IPF is a progressive fibrotic lung disease, which typically has a mortality rate of 3-5 years,” Good explained. “One of the biggest complaints of this disease is chronic coughing,” she added. “We are trying to settle down the coughing, which may in return impact the underlying disease,” she said. “This was a proof-of-concept trial in which we reported full results in September, and the data was significantly positive.”
“We had a response to the drug with about a 75% reduction of the cough over three weeks, which is a tremendous impact,” continued Good. “That was exciting for us, and there was nothing new found on the safety side,” she shared. “We are now moving forward with cough as our main focus,” said Good. “We were also able to raise money, so we now have plenty of cash to execute these next phases of development.”
“What do you have planned for this year in terms of clinical trials?”, asked Jolly. “It will be a very busy year for us clinically,” said Good, adding that 2022 was a significant year for the Company in terms of de-risking their oral therapy. “We have enough cash to take us into 2026,” she shared. “This year, we are going to do a dose-ranging study,” said Good. “It will be with roughly 200 patients, 50 per our three dosage strengths and a placebo, and we plan to start that in the second quarter of this year,” explained Good. “In parallel to that, we are also going to run a Phase 1B safety study.”
“We will also plan to initiate a refractory chronic cough study, which is a big market and a different cough indication,” continued Good, before elaborating on the significance and potential of this study. “This will be a crossover study and we plan to start that in the third quarter of this year.”
Jolly then asked about the Company’s recent addition of Dr. David Clark as their Chief Medical Officer. “David has a strong respiratory background, which is quite relevant as we work our way through our cough program,” said Good. “He also has a history of working as a CMO for companies doing rare disease work,” she added. “David has had a lot of success at designing key trials that have been game changing for their companies. In fact, two of his companies have been acquired for healthy premiums.”
To close the interview, Good elaborated on the Company’s potential as they continue to develop and de-risk their chronic cough indication. “I think we are well positioned now to get this out to a broader market,” said Good. She also encouraged listeners and shareholders to keep up-to-date on the Company’s upcoming announcements and current projects as they continue to progress clinically.
To hear Jennifer Good’s entire interview, follow the link to the podcast here: https://audioboom.com/posts/8235624-trevi-therapeutics-inc-discusses-progress-and-2022-success-of-clinical-studies-for-its-investig
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational oral therapy Haduvio™ (nalbuphine ER) for the treatment of chronic cough in adults with IPF, other chronic cough indications, and for the treatment of prurigo nodularis. The Company reported statistically significant results from the Phase 2 CANAL trial of Haduvio for the treatment of chronic cough in adults with IPF. Based on this positive data, Trevi plans to focus future clinical development on chronic cough conditions, including IPF, refractory chronic cough, and interstitial lung diseases (ILDs).
Haduvio, an investigational therapy, is an oral extended-release (ER) formulation of nalbuphine. Nalbuphine is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist that has been approved and marketed as an injectable for pain indications for more than 20 years in the United States and Europe. The ĸ- and µ-opioid receptors are centrally and peripherally active and known to be critical mediators of cough and itch. Nalbuphine’s mechanism of action may also mitigate the risk of abuse associated with µ-opioid agonists because it antagonizes, or blocks, µ-opioid receptors. Parenteral nalbuphine is not currently scheduled as a controlled substance by the DEA in the United States or by regulatory authorities in most of Europe. Trevi intends to propose Haduvio as the trade name for nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.
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 with respect to future 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, cost 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 the United States and foreign countries; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2022 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Trevi Therapeutics, Inc.
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