Trevi Therapeutics Inc
NASDAQ:TRVI
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.
Strong Clinical Data: Trevi reported positive data from both the CORAL and RIVER trials for chronic cough, generating significant interest among pulmonologists.
Financial Position: The company raised $115 million in June, ending Q3 with $195 million in cash and investments, which provides runway into 2028.
Phase III Preparations: Trevi is preparing to initiate Phase III trials in IPF chronic cough and a Phase IIb trial in refractory chronic cough in the first half of next year.
Regulatory Progress: Drug-drug interaction and respiratory safety studies showed no adverse signals, clearing a path for Phase III designs; end of Phase II meeting with the FDA expected in Q4.
Expanded Market Opportunity: Planning to include non-IPF interstitial lung diseases, which could more than double the potential patient pool.
Operational Efficiency: R&D expenses decreased due to completed trials, while G&A increased as the company prepares for SOX 404(b) compliance.
Orphan Drug Status: Trevi intends to seek orphan drug designation for Haduvio in IPF cough after the upcoming regulatory meeting.
