Phoenix, Arizona--(Newsfile Corp. - August 22, 2022) - The Stock Day Podcast welcomed Trevi Therapeutics, Inc. (NASDAQ: TRVI) ("the Company"), a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of prurigo nodularis (PN) and chronic cough in idiopathic pulmonary fibrosis (IPF). President and CEO of the Company, Jennifer Good, joined Stock Day host Sever Copley.
Copley began the interview by asking about the Company's novelty therapeutic, Haduvio. "Haduvio is a mixed ĸ-opioid receptor agonist and µ-opioid receptor antagonist," explained Good. "We focused on severe conditions, one is chronic cough in idiopathic pulmonary fibrosis (IPF), as well as a severe dermatological condition called prurigo nodularis (PN)."
Good then elaborated on the applicable treatments and conditions of their therapeutic. "People who are diagnosed with IPF typically only live 2-5 years," said Good. "We just released compelling data showing that we were able to reduce coughing by 77%," she shared from their phase 2 cough in IPF interim analysis data, noting that the treatment may have the potential to reduce micro tearing in the lungs.
"With PN, you get this unrelenting urge to scratch, which creates nodules on your skin," continued Good. "It eventually becomes neurological, so what we are trying to do is interrupt the signal to reduce that urge to scratch and allow the skin to heal," she said. "Again, we just put out compelling data on our ability to reduce itch and improve skin healing, as well as an overall improvement in quality of life."
"You are currently on the Phase III study for PN, is that correct?", asked Copley. "Yes," said Good. The Company completed the pivotal PN study and read out positive topline data June 2022. As for next steps, Good added "We will speak to the FDA, and hopefully be able to conduct the last trial and be able to file for this indication."
"What major catalysts are we looking at for this year and into 2023?", asked Copley. "This will be a clinical year for us," shared Good. "During the 3rd quarter we will report the full results of the rest of the patients, as well as some other end points," she said in response to the phase 2 cough in IPF trial. "We have also scheduled a meeting with the FDA during the 3rd quarter for that program."
"In parallel to that, I would say we are also looking at other indications," continued Good, adding that the Company hopes to add one to two more indications in the near future.
"Why does management believe that commercializing and developing Haduvio will be a success?", asked Copley. "We have purposefully picked conditions that have high unmet needs; they are very burdensome to the patient and there is no approved therapy," said Good, adding that the therapeutic is designed to both improve quality of life while also potentially altering the disease progression.
To close the interview, Good encouraged listeners to keep up-to-date on the Company's current and upcoming projects as they continue to move through the development and commercialization of their therapeutic.
To hear Jennifer Good's entire interview, follow the link to the podcast here: https://audioboom.com/posts/8143610-trevi-therapeutics-inc-discusses-commercialization-for-its-investigational-therapy-haduvio-wi
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of the investigational therapy Haduvio for the treatment of prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis. These conditions share a common pathophysiology that is mediated through opioid receptors in the central and peripheral nervous systems.
Founded in 2011, Trevi Therapeutics is headquartered in New Haven, CT.
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 known to be critical mediators of itch, cough and certain movement disorders. 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. Nalbuphine ER has been granted Fast Track designation by the FDA for the treatment of itch in patients with prurigo nodularis. 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 the expected timing of reporting top-line data from the full set of subjects' data from Trevi's Phase 2 CANAL trial of Haduvio in chronic cough in adults with IPF ; Trevi's business plans and objectives, including future plans or expectations for Haduvio; expectations regarding Trevi's uses and sufficiency of capital; 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, including with respect to the timing of reporting top-line data from the Phase 2 CANAL trial; uncertainties regarding Trevi's ability to execute on its strategy; the risk that positive interim or top-line results from a clinical trial may not necessarily be predictive of the results of the completed trial or other future or ongoing clinical trials; potential regulatory developments in the United States and foreign countries; uncertainties regarding fast track designation and the effect such status could have on the regulatory review or approval process; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to continue as a going concern, comply with its obligations under its loan facility and fund future operations; uncertainties regarding the scope, timing and severity of the COVID-19 pandemic, the impact of the COVID-19 pandemic on Trevi's clinical operations and actions taken in response to the pandemic; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended June 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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