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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 Phase 2 CANAL trial of Haduvio, an investigational therapy for chronic cough in patients with idiopathic pulmonary fibrosis. The trial showed a significant reduction in daytime cough frequency, with a 75.1% decrease compared to 22.6% for placebo (p<0.0001). Secondary endpoints also demonstrated consistent efficacy across patient-reported outcomes. The results were consistent with the interim analysis, and the company plans to initiate the next clinical trial in early 2023, as there are no approved therapies for chronic cough in IPF patients.
Trevi Therapeutics, a clinical-stage biopharmaceutical company, announced that its CEO, Jennifer Good, will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 10:30 AM ET. The presentation will highlight the investigational therapy Haduvio™ (oral nalbuphine ER), aimed at treating prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis. Trevi is focused on the development of Haduvio, which has received Fast Track designation from the FDA.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced a virtual R&D Day scheduled for September 19, 2022, from 10 AM to 12:30 PM ET. The event will feature expert presentations from Dr. Peter Dicpinigaitis and Dr. Brian Kim, focusing on chronic cough and prurigo nodularis. Trevi will provide updates on its investigational therapy Haduvio (oral nalbuphine ER), which aims to address unmet needs in these conditions. Participants can register and access a live webcast of the event.
Trevi Therapeutics, Inc. (TRVI) announced that two late-breaking abstracts have been accepted for oral presentations at upcoming medical conferences. The European Respiratory Society International Congress 2022, held in Barcelona from September 4-6, will feature data from the Phase 2 CANAL trial on the use of Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF). Similarly, the EADV Congress in Milan from September 7-10 will present findings from the Phase 2b/3 PRISM trial on prurigo nodularis. Both trials reported statistically significant efficacy results.
Trevi Therapeutics reported positive results from the Phase 2b/3 PRISM trial of its investigational therapy, Haduvio™, for treating Prurigo Nodularis. The trial achieved its primary endpoint, with 25% of Haduvio patients showing a significant reduction in itch compared to 14% on placebo (p=0.0157). The company completed a $55 million private placement to support further clinical development. For Q2 2022, Trevi's total cash was $78.9 million, with a net loss of $8.1 million, improved from $9.8 million in Q2 2021.
Future data from the Phase 2 CANAL trial on chronic cough is expected later this quarter.
Trevi Therapeutics, Inc. (NASDAQ: TRVI) announced its participation in two key conferences in August 2022. On August 16, CEO Jennifer Good will engage in a fireside chat at the Stifel Biotech Executive Summer Summit. On August 29, CMO Thomas Sciascia and Professor Toby Maher will co-host a workshop at the 6th Annual IPF Summit in Boston, emphasizing chronic cough treatment strategies. Trevi's investigational therapy Haduvio is being developed for prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis, with FDA Fast Track designation for itch treatment.
Trevi Therapeutics (Nasdaq: TRVI) will host a conference call and live audio webcast on August 11, 2022, at 4:30 p.m. ET, to discuss its Q2 2022 financial results and provide a corporate update. The company is developing Haduvio (oral nalbuphine ER) as a treatment for prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis. Haduvio has received FDA Fast Track designation for the treatment of itch. More information can be accessed on the company’s website.
Trevi Therapeutics (Nasdaq: TRVI), a clinical-stage biopharmaceutical company, will participate in The Twelfth London International Cough Symposium on July 13-14, 2022. The event will focus on advancements related to acute and chronic cough, including novel treatments. Trevi is developing Haduvio (oral nalbuphine ER) aimed at treating prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis patients. Haduvio has received Fast Track designation from the FDA for reducing pruritus in affected adults, though its efficacy is yet to be evaluated by regulatory authorities.
Trevi Therapeutics (TRVI) announced positive results from its Phase 2b/3 PRISM trial evaluating Haduvio for treating prurigo nodularis. The trial achieved statistical significance with a 4-point reduction in the Worst Itch – Numerical Rating Scale (WI-NRS) for 25% of Haduvio patients compared to 14% for placebo (p=0.0157). Key secondary endpoints were also met. The drug's safety profile was consistent with prior studies. Topline results will be discussed in a conference call on June 29, 2022, at 8:30 am EDT, highlighting Haduvio's potential in addressing severe itching and enhancing quality of life.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced that its President and CEO, Jennifer Good, will present at the 2022 BIO International Convention on June 13 at 4 PM PT in San Diego, CA. The convention is expected to attract over 15,000 leaders in biotechnology and pharma, focusing on networking and partnership opportunities. Trevi is developing Haduvio™, an investigational therapy for pruritus in prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis, and is currently conducting Phase 2b/3 and Phase 2 clinical trials for these conditions.
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