Trevi Therapeutics Inc
NASDAQ:TRVI
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Trevi Therapeutics Inc
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization Haduvio to treat serious neurologically mediated conditions. The company is headquartered in New Haven, Connecticut and currently employs 24 full-time employees. The company went IPO on 2019-05-07. The firm is engaged in developing Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The company is also developing Haduvio in levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. The company is conducting a Phase 2b/3 clinical trial of Haduvio in patients with severe pruritus associated with prurigo nodularis. The company is also conducting a Phase 2 clinical trial of Haduvio for chronic cough in patients with IPF. The company has also commenced a Phase 1b clinical trial in patients with chronic liver disease to evaluate the safety, pharmacokinetics of Haduvio in this population. The Company’s nalbuphine ER development programs are Chronic Pruritus, Pruritus in Chronic Liver Disease and Uremic Pruritus Programs.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization Haduvio to treat serious neurologically mediated conditions. The company is headquartered in New Haven, Connecticut and currently employs 24 full-time employees. The company went IPO on 2019-05-07. The firm is engaged in developing Haduvio for the treatment of chronic pruritus associated with prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The company is also developing Haduvio in levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease. The company is conducting a Phase 2b/3 clinical trial of Haduvio in patients with severe pruritus associated with prurigo nodularis. The company is also conducting a Phase 2 clinical trial of Haduvio for chronic cough in patients with IPF. The company has also commenced a Phase 1b clinical trial in patients with chronic liver disease to evaluate the safety, pharmacokinetics of Haduvio in this population. The Company’s nalbuphine ER development programs are Chronic Pruritus, Pruritus in Chronic Liver Disease and Uremic Pruritus Programs.
Program update: Trevi received constructive end-of-Phase II feedback from the FDA for IPF-related chronic cough and will run two pivotal Phase III trials in parallel (a global 52-week trial with a 24-week primary efficacy readout and a smaller global 12-week trial).
Timelines: First Phase III to be initiated in Q2 this year; second Phase III expected to start in H2.
Scope/size: The 24-week/52-week trial is planned for ~300 patients; the 12-week confirmatory trial ~130 patients.
Additional programs: Trevi plans an adaptive Phase IIb -> pivotal approach for non-IPF ILD chronic cough (meeting planned with FDA in Q3) and a Phase IIb 3-dose plus placebo RCC trial starting in Q2 with a sample-size reestimation readout when 50% of patients complete.
Cash runway: Ended 2025 with approximately $188 million, which management says funds operations into 2028 and covers top-line data for the listed trials.
Market opportunity: U.S. IPF population cited at ~150,000 with ~2/3 having uncontrolled chronic cough; non-IPF ILD ~228,000 with 50%–60% uncontrolled cough.
Safety / scheduling: Management reiterated confidence that the drug will remain unscheduled; the FDA requested standard label-enabling studies (DDIs, hepatic/renal impairment, food effect, etc.).
