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Overview of Trevi Therapeutics, Inc.
Trevi Therapeutics (TRVI) is a clinical-stage biopharmaceutical company dedicated to transforming treatment paradigms for chronic cough and pruritic conditions. The company is deeply involved in the research and development of Haduvio™, an innovative oral extended-release formulation of nalbuphine. Harnessing a unique dual mechanism of action, Haduvio functions as a kappa-opioid receptor agonist and a mu-opioid receptor antagonist. This dual action is central to its potential to provide symptomatic relief in conditions characterized by chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), as well as in dermatologic disorders such as prurigo nodularis.
Scientific and Clinical Rationale
The core of Trevi's approach lies in addressing a significant unmet medical need. In diseases like IPF and RCC, chronic cough is not only debilitating but also correlates with a decline in patients' overall quality of life. Haduvio’s design specifically targets the cough reflex arc through both central and peripheral pathways. By modulating opioid receptors, its mechanism aims to reduce cough frequency and severity without the inherent risks associated with conventional opioid therapies. The investigational therapy is grounded in robust clinical research, with various ongoing trials designed to ascertain its efficacy, safety, and optimal dosing across multiple patient subgroups.
Clinical Development and Research Programs
Trevi Therapeutics is rigorously evaluating Haduvio in numerous clinical settings. The company has instituted several trials, including randomized controlled studies, to evaluate the therapy's impact on 24-hour cough frequency and associated patient-reported outcomes. Key studies include Phase 2a and Phase 2b trials that measure objective cough metrics and patient quality of life indicators. These trials are meticulously designed with endpoints that evaluate both clinical efficacy and potential safety considerations, such as the abuse potential of nalbuphine. Through its comprehensive clinical program, Trevi is focused on gathering robust data that can support regulatory submissions and ultimately provide an alternative treatment where no approved therapies currently exist.
Market Position and Unmet Needs
Chronic cough in IPF and RCC represents a significant area of concern due to the absence of approved treatments in many regions. Trevi Therapeutics positions itself within this niche by offering a therapy that directly targets the underlying physiological mechanisms of cough hypersensitivity. With millions of potential patients and a high prevalence of chronic cough in affected populations, the company addresses the dual challenges of efficacy and patient tolerability using an innovative formulation. This strategic focus on a high unmet need segment bolsters its potential market significance and underscores its commitment to advancing medical science in a challenging therapeutic area.
Operational Excellence and Strategic Considerations
Trevi Therapeutics exhibits a robust operational framework, integrating advanced clinical trial methodologies and state-of-the-art pharmaceutical research. The company's structured approach to trial design, endpoint assessment, and safety evaluation reinforces its authority in the biopharmaceutical domain. Its strategy reflects a nuanced understanding of both the clinical and commercial landscapes, ensuring that scientific precision is coupled with a patient-centric focus. By emphasizing rigorous research, clear strategic milestones, and targeted clinical endpoints, Trevi demonstrates a balanced and expert approach to innovation in therapeutic development.
Conclusion
In summary, Trevi Therapeutics is a forward-thinking clinical-stage biopharmaceutical enterprise poised to redefine treatment standards for chronic cough and pruritic conditions. Through the development of Haduvio™, the company leverages sophisticated pharmacological mechanisms to address significant clinical challenges and empower patients with limited treatment options. Its commitment to comprehensive research, detailed clinical evaluation, and operational excellence cements its role as a critical player in the evolving landscape of respiratory and dermatologic therapeutics.
Trevi Therapeutics (NASDAQ: TRVI) announced positive results from its planned sample size re-estimation (SSRE) for the Phase 2b CORAL trial, confirming no changes needed to the current sample size of 160 patients. The trial, testing Haduvio™ for chronic cough in idiopathic pulmonary fibrosis (IPF) patients, has reached 75% enrollment, with topline results expected in H1 2025.
The SSRE analysis, conducted on the highest dose (108mg twice daily) after 80 patients completed treatment, supported maintaining the pre-specified conditional power of 80% or greater. The CORAL trial is evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) against placebo in IPF patients with chronic cough, with the primary endpoint measuring relative change in 24-hour cough frequency.
Trevi Therapeutics (NASDAQ: TRVI) announced positive results from their human abuse potential (HAP) study of oral nalbuphine. The study demonstrated statistically significant lower 'Drug Liking' for clinical doses (81mg and 162mg) compared to 6mg IV butorphanol. The primary endpoint measured peak effect for 'Drug Liking' on a 100-point visual analog scale.
Key findings showed mean Emax 'Drug Liking' scores of 71.2 and 74.5 for 81mg and 162mg oral nalbuphine respectively, compared to 82.3 for butorphanol (p<0.0001 and p=0.0008). Secondary endpoints were consistent with primary findings. The supratherapeutic dose (486mg) showed numerically lower but not statistically significant results. No serious adverse events were reported.
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.
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