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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 (TRVI) announced a private placement with a healthcare-focused institutional investor, raising approximately $11.8 million. The agreement involves the sale of 2,373,201 shares of common stock and accompanying warrants, priced at $1.62 per share, as well as pre-funded warrants. The company plans to use the proceeds to advance its investigational therapy, Haduvio™, targeting neurologically mediated conditions such as chronic pruritus and chronic cough. The private placement is expected to close on October 4, 2021.
Trevi Therapeutics (Nasdaq: TRVI) reported Q2 2021 financial results, revealing a net loss of $9.8 million, a significant increase from a net loss of $7.4 million in Q2 2020. As of June 30, 2021, Trevi had $36.4 million in cash, down from $45.0 million at the end of 2020. Approximately 80% of participants have enrolled in the Phase 2b/3 PRISM trial for Haduvio, with top-line data expected in 1H 2022. The company is also progressing in its CANAL trial for chronic cough, and recently expanded its management team.
Trevi Therapeutics (Nasdaq: TRVI) has appointed Lisa Delfini as Chief Financial Officer and Danine Summers as Vice President of Medical Affairs. Delfini, with 30 years of experience, will oversee financial operations and capital activities. Summers, an accomplished Medical Affairs executive, will focus on educating healthcare professionals regarding Haduvio’s data and development. Both appointments are expected to strengthen Trevi's leadership as it advances its Phase 2b/3 PRISM trial and Phase 2 CANAL trial for Haduvio, aimed at treating serious neurologically mediated conditions.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) will host a conference call and audio webcast on August 12, 2021, at 4:30 p.m. ET to discuss its financial results for the quarter ending June 30, 2021 and provide a corporate update. The company is focused on developing Haduvio (nalbuphine ER) for serious neurologically mediated conditions, currently conducting Phase 2b/3 clinical trials for chronic pruritus associated with prurigo nodularis and Phase 2 trials for chronic cough in idiopathic pulmonary fibrosis patients.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced that CEO Jennifer Good will present at the 2021 BIO Digital conference on June 10-11 and June 14-18. Haduvio™ (nalbuphine ER), Trevi's investigational therapy for serious neurologically mediated conditions, is currently undergoing Phase 2b/3 trials for chronic pruritus and Phase 2 trials for chronic cough. The presentation is available to registered attendees from 9am ET June 10 until the conference ends on June 18, with an archived replay accessible for 30 days via Trevi's website.
Trevi Therapeutics (Nasdaq: TRVI) reported its Q1 2021 financial results on May 13, 2021, highlighting key advancements in its clinical trials. The company has enrolled approximately 255 subjects in the PRISM trial for moderate to severe pruritus in prurigo nodularis and received FDA Fast Track designation for this indication. With a cash position of $41.6 million, Trevi expects to fund operations through Q2 2022. The net loss reported for Q1 2021 was $8.4 million, a slight decrease compared to $8.5 million in the same period last year.
Trevi Therapeutics, Inc. (NASDAQ: TRVI) will host a conference call on May 13, 2021, at 4:30 p.m. ET to discuss its Q1 2021 financial results and provide a corporate update. The company is developing Haduvio™ (nalbuphine ER) for serious neurologically mediated conditions, including chronic pruritus associated with prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis patients. Haduvio is currently undergoing Phase 2b/3 clinical trials. An archived replay of the conference call will be available on Trevi's website.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) will participate in the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021, with a presentation at 2:15 p.m. ET. The company focuses on developing Haduvio™ (nalbuphine ER) for serious neurologically mediated conditions. Investors can access a live webcast on the company's website, along with an archived replay available for 30 days post-conference. Trevi is conducting clinical trials for Haduvio targeting chronic pruritus, chronic cough in idiopathic pulmonary fibrosis, and levodopa-induced dyskinesia.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced its Q4 2020 and annual financial results, reporting a net loss of $9.5 million for Q4 and $32.8 million for the year. R&D expenses rose to $22.3 million, driven by clinical trial activities. The company is progressing in its Phase 2b/3 PRISM trial, expecting to complete enrollment of 360 subjects by Q3 2021, with top-line data anticipated in Q4 2021. As of December 31, 2020, Trevi had $45 million in cash, expected to fund operations into Q2 2022.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced a conference call on March 25, 2021, at 4:30 p.m. ET to discuss its corporate update and financial results for the year ended December 31, 2020. The company is focused on developing Haduvio (nalbuphine ER) for serious neurologically mediated conditions. Currently, Trevi is conducting a Phase 2b/3 clinical trial for chronic pruritus and a Phase 2 trial for chronic cough related to idiopathic pulmonary fibrosis. The company is also planning a Phase 2 study for treating levodopa-induced dyskinesia in Parkinson’s patients.
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