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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 participation in several investor events in May 2023. The events include the Aegis Virtual Conference from May 2-4, where senior management will present on May 3, and the American Thoracic Society's Respiratory Innovation Summit from May 19-20, with a presentation on May 20. Additionally, Trevi will be featured at the Yale Innovation Summit from May 31 to June 1. The focus of Trevi Therapeutics is on Haduvio™, an investigational therapy for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and other conditions. Haduvio aims to provide a novel treatment through an oral formulation of nalbuphine. Trevi's leadership, including President and CEO Jennifer Good, will address investors at these key events.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced participation in the 22nd Annual Needham Virtual Healthcare Conference on April 17, 2023, at 11:00 a.m. ET. Key executives, including Jennifer Good (CEO), Lisa Delfini (CFO), and David Clark (CMO), will engage in a fireside chat. They will also hold investor meetings during the conference. Trevi is developing the investigational therapy Haduvio™ (oral nalbuphine ER) for chronic cough related to idiopathic pulmonary fibrosis and prurigo nodularis. A live webcast will be available on the company's website, with an archived replay accessible for 30 days post-event. Haduvio is a mixed receptor agonist and antagonist, targeting cough mediation. Safety and efficacy evaluations are pending regulatory review.
Trevi Therapeutics (TRVI) announced its fourth quarter and full-year 2022 financial results, reporting a net loss of $5.5 million for Q4, down from $8.5 million in Q4 2021. Total operating expenses decreased to $6.7 million, driven by lower R&D costs of $4.3 million. As of December 31, 2022, Trevi had $120.5 million in cash and marketable securities, which supports operations into 2026. The company plans multiple trial initiations for its investigational therapy Haduvio in chronic cough and prurigo nodularis in 2023, with FDA discussions ongoing. The full data from the Phase 2b/3 PRISM trial is expected in Q2 2023.
Trevi Therapeutics (Nasdaq: TRVI) announced a conference call scheduled for March 16, 2023, at 4:30 p.m. ET to discuss its fourth quarter and full-year financial results for 2022. The company, focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough associated with idiopathic pulmonary fibrosis (IPF) and prurigo nodularis, encourages participation via phone or webcast. Haduvio is a mixed μ-opioid receptor antagonist and κ-opioid receptor agonist, with safety and efficacy not yet evaluated by regulatory authorities. More information can be accessed from their official website.
Trevi Therapeutics, Inc. (NASDAQ: TRVI) announced a key milestone on March 7, 2023, as the USPTO granted a notice of allowance for the patent covering its investigational therapy Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). This patent is expected to be Orange Book-listable with an expiration in 2039, enhancing Trevi's intellectual property portfolio. Currently, there are no approved treatments for chronic cough in IPF, affecting approximately 140,000 patients in the U.S. Haduvio is a mixed opioid receptor therapy that aims to address this significant health issue.
Trevi Therapeutics (NASDAQ: TRVI) announced its participation in several upcoming conferences in March 2023. The events include the Frazier/Fenwick Winter Investor Event from March 7-10, the Oppenheimer 33rd Annual Healthcare Conference on March 13-15 with a corporate presentation on March 13 at 4:00 p.m. ET, and BIO-Europe Spring on March 20-22 (in-person) and March 28-30 (virtual). Trevi is focused on Haduvio™ (oral nalbuphine ER) for chronic cough treatment in adults with idiopathic pulmonary fibrosis and prurigo nodularis, reporting positive results from its Phase 2 CANAL trial.
Trevi Therapeutics (Nasdaq: TRVI) will present at the Emerging Growth Conference on February 22, 2023, at 10:50 a.m. ET. The presentation will focus on its investigational therapy Haduvio™ (oral nalbuphine ER) targeting chronic cough in adults with idiopathic pulmonary fibrosis (IPF) and prurigo nodularis. Senior leadership, including Jennifer Good, David Clark, and Farrell Simon, will engage in a Q&A session following the presentation. Interested parties can register for the event and access the live webcast on Trevi’s website, with an archived replay available post-event.
Trevi Therapeutics plans to present its investigational therapy Haduvio™ at two major investor conferences in February 2023. The BIO CEO & Investor Conference will take place from February 6-9, with Trevi’s presentation scheduled for February 7 at 10:45 a.m. ET. The SVB Securities Global Biopharma Conference follows from February 13-16, where a presentation is set for February 14 at 11:20 a.m. ET. Trevi Therapeutics, trading under the symbol TRVI, is developing Haduvio for chronic cough and prurigo nodularis, having reported promising Phase 2 trial results for chronic cough in patients with idiopathic pulmonary fibrosis.
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