Haduvio (nalbuphine ER) / Trevi Therap, Endo - LARVOL DELTA

Relative Bioavailability of Single-Dose Oral Administration of Two SHR7280 Formulations (Dry Suspension and Tablets) in Healthy Chinese Volunteers. (PubMed, Clin Drug Investig) - P1 | "The bioavailability of SHR7280 tablets was found to be comparable to that of dry suspension. The safety profile of two formulations was favorable. No serious adverse events or adverse drug reactions were reported."

Journal • Oncology • Ovarian Cancer • Solid Tumor

Effectiveness of a Web-Based Virtual Simulation to Train Nursing Students in Suicide Risk Assessment: Randomized Controlled Investigation. (PubMed, JMIR Serious Games) - "The VS group exhibited significantly higher confidence (3 points of increase after TAU vs 10.6 points of increase after VS, B=7.2; SE 2.5; t111.5=2.8; P=.006) and a marginally enhanced ability to respond appropriately to suicidal thoughts (1.6 points of improvement after TAU vs 6.4 points of improvement after VS, B=-4.5; SE 2.5; t119.5=-1.8; P=.08) compared with the control group...The use of VS demonstrated promising results in enhancing nursing students' confidence in detecting suicide risk and their skills in counseling individuals experiencing a suicide crisis, suggesting its incorporation into routine teaching methods. Further research is needed to explore its long-term benefits for students and its impact on patient outcomes."

Journal • CNS Disorders • Depression • Psychiatry • Suicidal Ideation

A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Trevi Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open

Late Breaking Abstract - Efficacy and safety of nalbuphine extended-release in refractory chronic cough: results from the phase 2a RIVER trial (ERS 2025) - No abstract available

Clinical • Late-breaking abstract • P2a data • Chronic Cough • Cough • Respiratory Diseases

Late Breaking Abstract - Responder analysis of nalbuphine extended-release in refractory chronic cough: results from the RIVER phase 2a trial (ERS 2025) - No abstract available

Late-breaking abstract • P2a data • Chronic Cough • Cough • Respiratory Diseases

Potent Acridone Antimalarial against All Three Life Stages of Plasmodium. (PubMed, Res Sq) - "Attributes of lead candidate T111 include potent in vitro activity against cultured parasites, ex vivo activity against clinical isolates, oral single dose cure in an asexual blood stage rodent model, inhibition of sexual blood stage parasites, activity against relapsing parasites in non-human primate liver cells, prevention of parasite development in mosquitoes, and synergy in combination with tafenoquine against blood and liver stage parasites. Safety profiles, including toxicology evaluations in rats, showed a favorable therapeutic index. Overall, T111 emerges as a promising candidate for treatment and prevention of malaria."

Journal • Infectious Disease • Malaria

CORAL: Cough Reduction in IPF With Nalbuphine ER (clinicaltrials.gov) - P2 | N=165 | Completed | Sponsor: Trevi Therapeutics | Recruiting ➔ Completed

Trial completion • Cough • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

NAL ER IPF Respiratory Function and Safety Study (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: Trevi Therapeutics

New P1 trial • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PRISM Study-Pruritus Relief Through Itch Scratch Modulation (clinicaltrials.gov) - P2/3 | N=353 | Completed | Sponsor: Trevi Therapeutics | Phase classification: P2b ➔ P2/3

Phase classification • Dermatology • Immunology • Prurigo Nodularis • Pruritus

A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants (clinicaltrials.gov) - P1 | N=115 | Not yet recruiting | Sponsor: Trevi Therapeutics

New P1 trial

Trevi Therapeutics Announces Positive Topline Results from the Phase 2b CORAL Trial of Haduvio in Patients with Idiopathic Pulmonary Fibrosis Chronic Cough (Yahoo Finance) - P2b | N=160 | CORAL (NCT05964335) | Sponsor: Trevi Therapeutics | "Trevi Therapeutics, Inc...is pleased to announce today positive topline results from its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF (N=165). The primary endpoint in the CORAL trial was achieved, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at Week 6. The 108 mg BID, 54 mg BID and 27 mg BID dose groups achieved reductions from Baseline of 60.2% (p<0.0001), 53.4% (p<0.0001), and 47.9% (p<0.01), respectively, compared to a placebo reduction from Baseline of 16.9%1. Statistically significant improvements were observed across secondary endpoints at Week 6 in the 108 mg BID and 54 mg BID dose groups....Trevi plans to request an End-of-Phase 2 meeting with the FDA later this year and is planning to initiate the Phase 3 program in the first half of 2026."

FDA event • New P3 trial • P2b data • Chronic Cough • Idiopathic Pulmonary Fibrosis

Trevi Therapeutics to Host Conference Call and Webcast on June 2nd to Share Topline Results from the Phase 2b CORAL Trial of Haduvio in Patients with Idiopathic Pulmonary Fibrosis Chronic Cough (PRNewswire) - "Trevi Therapeutics...announced a conference call and live webcast taking place tomorrow, Monday, June 2nd, 2025, at 8:30 a.m. ET, to share topline results from the Phase 2b CORAL trial of Haduvio in patients with IPF chronic cough."

P2b data • Chronic Cough • Idiopathic Pulmonary Fibrosis

Identifying antimalarials that disrupt malaria parasite transmission when fed to the mosquito. (PubMed, Int J Parasitol) - "Azithromycin, an antibiotic targeting apicoplast protein synthesis, significantly lowered sporozoite infectivity in mice. T111, a next generation compound targeting the parasite electron transport chain, reduced sporozoite numbers in P. berghei at equivalent concentrations to the gold standard electron transport chain inhibitor, atovaquone...Our findings suggest that several antimalarials can be used to target mosquito-stage parasites via sugar baits and limit malaria transmission. Importantly, mosquito feeding of antimalarials could vastly increase the range of potentially useful parasiticidal compounds to include those failing to meet the exacting standards required for human antimalarial drugs, potentially improving malaria control for minimal cost."

Journal • Infectious Disease • Malaria

Trevi Therapeutics Reports First Quarter 2025 Financial Results and Provides Business Updates (PRNewswire) - "Completed enrollment and last patient last visit in the Phase 2b CORAL trial in IPF patients with chronic cough; topline results continue to be expected in the second quarter of 2025."

P2b data • Trial status • Chronic Cough • Idiopathic Pulmonary Fibrosis

Development of Next-Generation Antimalarial Acridones with Radical Cure Potential. (PubMed, J Med Chem) - "Building from our previous lead compound T111 (1) possessing activity against both Plasmodium falciparum asexual blood-stage (ABS) and Plasmodium berghei liver-stage (LS) parasites, next-generation antimalarial acridones were systematically designed and synthesized...Notably, newer generation acridones substantially mitigated cross-resistance with atovaquone...Furthermore, compound 28 demonstrated a low risk of both genotoxicity and cardiotoxicity and was highly effective against ART-resistant parasites. This study demonstrated the first and robust antirelapse LS activity from a novel acridone family."

Journal • Cardiovascular • CNS Disorders • Infectious Disease • Psychiatry • Schizophrenia

Trevi Therapeutics Reports Fourth Quarter and Year End 2024 Financial Results and Provides Business Updates (PRNewswire) - "Completed enrollment in the Phase 2b CORAL trial in IPF patients with chronic cough in February 2025, with topline data expected in the second quarter of 2025....Ended 2024 with $107.6 million in cash, cash equivalents and marketable securities, with expected cash runway into the second half of 2026....R&D expenses: R&D expenses for the year ended December 31, 2024, were $39.4 million compared to $23.7 million in 2023. The increase was primarily due to increased clinical development expenses for the Phase 2b CORAL trial, the Phase 2a RIVER trial, the HAP study, and the Phase 1b TIDAL study, as well as an increase in personnel-related expenses and stock-based compensation expense. These increases were partially offset by decreased clinical development expenses for our Phase 2b/3 PRISM trial."

Commercial • P2b data • Chronic Cough • Idiopathic Pulmonary Fibrosis

Refractory Chronic Cough Improvement Via NAL ER (RIVER) (clinicaltrials.gov) - P2 | N=66 | Completed | Sponsor: Trevi Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Trevi Therapeutics Announces Positive Topline Results from the Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough (PRNewswire) - P2a | N=60 | RIVER (NCT05962151) | Sponsor: Trevi Therapeutics. | "Trevi Therapeutics, Inc....is pleased to announce today positive topline results from its Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66). Haduvio met the primary endpoint with a statistically-significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis (p<0.0001)....A statistically-significant reduction in 24-hour cough frequency, as measured by an objective cough monitor, was seen as early as Day 7 (27 mg BID) for patients on Haduvio (p<0.0001)."

P2a data • Chronic Cough

Trevi Therapeutics to Host Conference Call and Webcast on March 10th to Share Topline Results from the Phase 2a RIVER Trial of Haduvio in Patients with Refractory Chronic Cough (PRNewswire) - "Trevi Therapeutics...announced a conference call and live webcast taking place tomorrow, Monday, March 10th, 2025, at 8:30 a.m. ET, to share topline results from the Phase 2a RIVER trial of Haduvio in patients with refractory chronic cough."

P2a data • Chronic Cough

Trevi Therapeutics Completes Enrollment for Phase 2b CORAL Trial of Haduvio in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough (PRNewswire) - "Trevi Therapeutics...announced that it has completed enrollment in its Phase 2b CORAL trial of Haduvio for the treatment of chronic cough in patients with IPF. Topline results continue to be expected in the first half of 2025."

Enrollment closed • P2b data • Chronic Cough • Idiopathic Pulmonary Fibrosis

Trevi Therapeutics Announces Company Updates Ahead of 14th Annual LifeSci Partners Corporate Access Event Held During the J.P. Morgan Healthcare Conference (PRNewswire) - "Last patient completed the Phase 2a RIVER trial in refractory chronic cough (RCC) in early January and topline results continue to be expected in the first quarter of 2025; Approximately 80% of enrollment complete in the Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough and topline results continue to be expected in the first half of 2025..."

P2a data • P2b data • Trial status • Chronic Cough • Idiopathic Pulmonary Fibrosis

Compromising the immunogenicity of diphtheria toxin-based immunotoxins through epitope engineering: An in silico approach. (PubMed, J Pharmacol Toxicol Methods) - "Pseudomonas exotoxin A and diphtheria toxin (DT) have been abundantly used in immunotoxins, with the latter applied as the toxin moiety of the FDA-approved drug Denileukin diftitox (ONTAK®)...By subtracting conserved and ligand-binding residues, K33, T111, and E112 were identified as common epitopes across all platforms...Finally, a 3D model of the mutant was generated and verified. The model was then docked with its native ligand NADH, and the complex's molecular behavior was simulated using molecular dynamics."

Journal • Infectious Disease

CHEST 2024 Key Takeaways: Innovations in IPF and PAH: Episode 4 Evaluating Cough Relief With Oral Nalbuphine in Patients With IPF (AJMC) - "Steven Nathan, MD, discusses the abstract 'Analysis of Relief-of-Cough in Patients With Idiopathic Pulmonary Fibrosis Treated With Oral Nalbuphine Extended Release,' which aimed to assess the effectiveness of oral nalbuphine extended release in providing relief from chronic cough in patients with IPF; the study used a clinical trial design to evaluate cough severity, with results showing that nalbuphine significantly reduced cough frequency and intensity, offering a potential new treatment option for managing this common and debilitating symptom of IPF."

Video • Idiopathic Pulmonary Fibrosis

Trevi Therapeutics Announces Positive Outcome from Sample Size Re-estimation Resulting in No Change to the Current Sample Size for the Phase 2b CORAL Trial in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough (PRNewswire) - "Trevi Therapeutics, Inc...today announced the positive outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in IPF patients with chronic cough, which requires no change to the current sample size for the trial (N=160). The trial has reached 75% of the targeted enrollment, and topline results from the full trial continue to be expected in the first half of 2025...Based on the SSRE analysis, it was recommended that the CORAL trial should continue as planned to maintain the pre-specified conditional power of 80% or greater. The other two potential pre-specified outcomes of the SSRE analysis were an increase in the sample size or futility."

Enrollment status • P2b data • Chronic Cough • Idiopathic Pulmonary Fibrosis

PO Pain Management with Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery (clinicaltrials.gov) - P4 | N=76 | Completed | Sponsor: Tri-Service General Hospital | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jun 2024

Surgery • Trial completion • Trial completion date • Anesthesia • Orthopedics • Pain