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Trevi Therapeutics, Inc. (Nasdaq: TRVI) is a late-stage biopharmaceutical company devoted to addressing chronic pruritic conditions and chronic cough through its investigational therapy, Haduvio™ (oral nalbuphine ER). Haduvio is an oral extended-release formulation of nalbuphine, a synthetic opioid with a dual mechanism of action: as a ĸ-opioid receptor agonist and µ-opioid receptor antagonist. This unique mechanism has shown promise in clinical trials for reducing symptoms associated with chronic cough, particularly in idiopathic pulmonary fibrosis (IPF), refractory chronic cough (RCC), and prurigo nodularis, a dermatologic condition characterized by pruriginous lesions.
Trevi is advancing various pruritic conditions through clinical development, including prurigo nodularis, which currently has no approved therapies in the US or EU. The company's lead indication involves extensive studies and trials, such as the recent Phase 2b/3 PRISM (Pruritus Relief through Itch-Scratch Modulation) trial, which demonstrated Haduvio's efficacy and safety over 52 weeks.
In the chronic cough segment, Trevi's Haduvio is undergoing trials like the Phase 2a RIVER study for RCC and the Phase 2b CORAL trial for chronic cough in IPF. The RIVER trial is a double-blind, placebo-controlled study evaluating Haduvio's impact on 24-hour cough frequency, while the CORAL trial investigates three dose levels of Haduvio against a placebo in IPF patients, assessing endpoints like cough frequency reduction and quality of life improvements.
Trevi's innovative approach aims to provide relief where current treatments fail, supported by promising clinical data and ongoing trials. The company's commitment to addressing unmet medical needs is reflected in its thorough and transparent communication with investors and stakeholders, ensuring that all developments are promptly shared, including financial results and future plans.
For more detailed information on Trevi Therapeutics, its clinical trials, and its forward-looking statements, visit TreviTherapeutics.com and follow the company on Twitter and LinkedIn.
Trevi Therapeutics (Nasdaq: TRVI) announced its participation in the Piper Sandler 36th Annual Healthcare Conference, scheduled for December 3-5 in New York. Jennifer Good, President and CEO, will deliver a corporate presentation on December 4, 2024, at 1:00 p.m. ET. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will also have its CEO and CFO participate in investor meetings during the event. The presentation and meetings will be accessible to in-person attendees.
Trevi Therapeutics (Nasdaq: TRVI) announced its third quarter 2024 financial results and business updates.
The company completed enrollment in the Phase 2a RIVER trial for refractory chronic cough (RCC), with topline results expected in Q1 2025. It also reached 50% enrollment in the Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF), with sample size re-estimation results due in December 2024.
Trevi ended Q3 2024 with $65.5 million in cash and equivalents, projecting a cash runway into the second half of 2026.
R&D expenses rose to $11.2 million from $6.3 million year-over-year, driven by increased clinical development costs. G&A expenses increased slightly to $2.9 million. The company reported a net loss of $13.2 million, compared to $7.7 million in Q3 2023.
Topline results from the Human Abuse Potential (HAP) study are expected in December 2024.
Trevi Therapeutics (NASDAQ: TRVI) has announced it will report its Q3 2024 financial results and provide a corporate update on November 6, 2024, at 4:30 p.m. ET. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will host a conference call and webcast. Participants can join via phone at (877) 870 4263 (domestic) or (412) 317 0790 (international). The webcast will be available on the company's website and archived for 30 days.
Trevi Therapeutics (Nasdaq: TRVI) has completed enrollment for its Phase 2a RIVER trial, evaluating Haduvio™ (oral nalbuphine ER) for refractory chronic cough (RCC). The company expects to report topline results in Q1 2025. The trial is a randomized, double-blind, placebo-controlled study conducted in the UK and Canada, designed to assess the efficacy, safety, and tolerability of Haduvio in RCC patients.
The primary endpoint is the mean change in 24-hour cough frequency, measured by an objective cough monitor. The study includes two subgroups based on cough frequency: moderate (10-19 coughs/hour) and high (≥20 coughs/hour). Secondary endpoints include patient-reported outcome measures for cough frequency and severity. Approximately 60 adult patients were enrolled in the trial.
Trevi Therapeutics, a clinical-stage biopharmaceutical company developing Haduvio™ for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), announced its participation in upcoming commercial and investor conferences. The company's senior management will attend three events:
1. 3rd Chief Commercial Officer Summit in Philadelphia, PA (October 23-24, 2024), where Farrell Simon will present on Commercial's Role in Clinical Trial Recruitment.
2. BIO-Europe in Stockholm, Sweden (November 4-6, 2024), with Farrell Simon representing Trevi.
3. Stifel 2024 Healthcare Conference in New York, NY (November 18-19, 2024), featuring a corporate presentation by Jennifer Good and Lisa Delfini.
These events provide opportunities for Trevi to showcase its progress in developing Haduvio™ and engage with industry professionals and investors.
Trevi Therapeutics (Nasdaq: TRVI) has provided updates on its clinical development programs for Haduvio™ (oral nalbuphine ER), an investigational therapy for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). The Phase 2b CORAL trial for IPF chronic cough has reached 50% enrollment, with sample size re-estimation results expected in December 2024. The Human Abuse Potential (HAP) study has completed dosing, with topline results expected in December 2024. The Phase 2a RIVER trial for RCC has enrolled the planned sample size but remains open for additional enrollment, with topline results now expected in Q1 2025. Trevi's CEO, Jennifer Good, expressed excitement about these milestones, highlighting the potential of Haduvio's unique mechanism to address the unmet need in IPF chronic cough.
Trevi Therapeutics (Nasdaq: TRVI) has appointed James V. Cassella, Ph.D., as Chief Development Officer (CDO). Dr. Cassella, who has been a board member for four years, brings over 35 years of experience in CNS drug development. He will play a important role in advancing Haduvio™, Trevi's investigational therapy for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
Dr. Cassella's extensive background includes successful drug approvals and leadership roles at companies like Concert Pharmaceuticals and Alexza Pharmaceuticals. He replaces Dr. David Clark, who has stepped down as Chief Medical Officer but will continue to consult for the company.
Trevi is preparing for Haduvio's pivotal development program in IPF, advancement in RCC, and regulatory submission. The company anticipates upcoming data read-outs, which Dr. Cassella will help navigate with his expertise in late-stage CNS drug development and regulatory experience.
Trevi Therapeutics (Nasdaq: TRVI) announced that additional analyses of cough relief time from their Phase 2a CANAL trial have been accepted for oral presentation at CHEST 2024. The presentation, by Professor Alyn Morice, will cover post-hoc analyses of 38 IPF patients who completed at least one treatment period. Results showed:
1. Significant increase in relief-of-cough time
2. Reduced cough time
3. Reduced cough intensity
These effects were observed in IPF patients treated with nalbuphine ER compared to placebo. The safety profile was consistent with previous trials. Common adverse events included nausea, dizziness, and anxiety. The presentation is scheduled for October 8, 2024, at the CHEST Annual Meeting in Boston.
Trevi Therapeutics (Nasdaq: TRVI) announced that data from their Phase 2a CANAL trial on Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF) will be presented at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria. The presentation, scheduled for September 8th, will focus on the correlation between changes in objective cough count and improvements in patient-reported outcomes with nalbuphine ER in IPF patients. Professor Jacky Smith, a renowned respiratory medicine expert, will deliver the oral presentation, highlighting the importance of patient-reported outcomes in clinical trials for chronic cough treatments, which remain a significant unmet need for IPF patients.
Trevi Therapeutics (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing Haduvio™ for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), announced its participation in several investor and medical conferences in September 2024. These include:
- 2024 Wells Fargo Healthcare Conference (Sept 4-6, Boston)
- European Respiratory Society Congress 2024 (Sept 7-11, Vienna)
- H.C. Wainwright 26th Annual Global Investment Conference (Sept 9-11, New York)
- 2024 Cantor Global Healthcare Conference (Sept 17-19, New York)
Senior management, including CEO Jennifer Good and CFO Lisa Delfini, will represent Trevi at these events. Corporate presentations are scheduled at the H.C. Wainwright and Cantor conferences, with the latter being available for public viewing via registration.
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