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

Efficacy and safety of nalbuphine extended-release in refractory chronic cough: results from the phase 2a RIVER trial (BTS WM 2025) - P2 | "The most common (≥10%) TEAEs were constipation, somnolence, nausea, dizziness, headache, and fatigue. Download figure Open in new tab Download powerpoint Abstract P113 Figure 1 Relative Change from Baseline at Day 21 (108 mg BID) Conclusions The significant reduction in 24-h cough frequency supports further investigation of NAL ER for RCC."

Clinical • P2a data • Chronic Cough • Constipation • Cough • Gastroenterology • Gastrointestinal Disorder • Renal Cell Carcinoma • Respiratory Diseases • STAT2

…Recent Business Highlights: Chronic Cough in IPF (PRNewswire) - "The Company is preparing to request an End-of-Phase 2 meeting in the fourth quarter of 2025 and to initiate its Phase 3 program in the first half of 2026. The safety review committee for the Phase 1 respiratory function and safety study in patients with IPF, which is referred to as TIDAL, met to review data for the sentinel cohort of patients and concluded there were no safety signals and gave approval to complete enrollment. The study is expected to be completed in the fourth quarter of 2025 and available data will be included in the End-of-Phase 2 meeting package."

DSMB • FDA event • New P3 trial • Trial completion • Chronic Cough • Idiopathic Pulmonary Fibrosis

…Recent Business Highlights:…Refractory Chronic Cough (PRNewswire) - "Following the positive Phase 2a RIVER trial results earlier this year, the Company is planning to initiate a Phase 2b RCC study in the first half of 2026."

New P2b trial • Chronic Cough

Hydrogen bonding exacerbates viscoelasticity of amino acid- and betaine surfactant self-assemblies. (PubMed, J Colloid Interface Sci) - "The formation of wormlike micelles of sodium N-lauroyl l-serinate (NaLSer) and laurylamidopropyl betaine (LAPB) are quantified by the characteristic scattering of elongated objects in small-angle neutron scattering, and by the distinct shear-thinning and viscoelasticity measured through rheometry. In stark contrast, the absence of hydrogen bonding groups inhibits elongation, only able to form inviscid, spheroidal micelles for mixtures of sodium N-lauroyl l-alaninate (NaLAla) and lauryl betaine (LB). It is evident that hydrogen bonding stimulates uni-axial growth of micelles, enhancing viscosity and control over flow properties for applications in personal care, active delivery and rheological modification."

Journal

A RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL-GROUP PHASE 2B TRIAL OF NALBUPHINE EXTENDED-RELEASE FOR CHRONIC COUGH IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (CHEST 2025) - P2 | "In a population with IPF and CC, treatment with NAL ER significantly reduced objective cough frequency and improved outcomes directly reported by patients. CLINICAL IMPLICATIONS: As cough is a major contributor to impaired quality of life in patients with IPF, this study is important because it shows that effective reduction of cough frequency and severity by use of NAL ER significantly improved patients' quality of life."

Clinical • Late-breaking abstract • P2b data • Chronic Cough • Constipation • Cough • Gastroenterology • Gastrointestinal Disorder • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

PATIENT-REPORTED OUTCOMES FROM A PHASE 2A TRIAL OF EXTENDED-RELEASE NALBUPHINE FOR PATIENTS WITH REFRACTORY CHRONIC COUGH (CHEST 2025) - P2 | "NAL ER treatment improved PRO measures in patients with RCC, including patient perception of cough severity and cough frequency. CLINICAL IMPLICATIONS: No therapies have been approved in the United States for patients with RCC. NAL ER treatment demonstrated significant improvement in objective and PRO measures, warranting further development of NAL ER for patients with RCC."

Clinical • Late-breaking abstract • P2a data • Patient reported outcomes • Chronic Cough • Cough • Renal Cell Carcinoma • Respiratory Diseases

A Study of the Pharmacokinetic Interaction Between Pirfenidone, Nintedanib, and Nalbuphine Extended Release (NAL ER) in Healthy Participants (clinicaltrials.gov) - P1 | N=132 | Completed | Sponsor: Trevi Therapeutics | Recruiting ➔ Completed

Trial completion

Trevi Therapeutics, Inc…announced the acceptance of two abstracts for presentation at the CHEST 2025 Annual Meeting, to be held from October 19 to 22 in Chicago, Illinois. (Trevi Therapeutics) - "The key safety and efficacy results from the Phase 2b CORAL dose-ranging trial of nalbuphine ER for the treatment of chronic cough in patients with IPF was accepted for oral presentation. Additionally, patient-reported outcome results from the Phase 2a RIVER proof-of-concept trial of nalbuphine ER for the treatment of patients with RCC will be featured as a poster presentation."

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

Late Breaking Abstract - Efficacy and safety of nalbuphine extended-release in refractory chronic cough: results from the phase 2a RIVER trial (ERS 2025) - P2 | "The significant reduction in 24-h cough frequency supports further investigation of NAL ER for RCC."

Clinical • Late-breaking abstract • P2a data • Chronic Cough • Constipation • Cough • Fatigue • Gastroenterology • Gastrointestinal Disorder • Renal Cell Carcinoma • Respiratory Diseases

Late Breaking Abstract - Responder analysis of nalbuphine extended-release in refractory chronic cough: results from the RIVER phase 2a trial (ERS 2025) - P2 | "These results support further investigation of NAL ER for the treatment of RCC."

Late-breaking abstract • P2a data • Chronic Cough • Cough • Renal Cell Carcinoma • Respiratory Diseases

Trevi Therapeutics Announces Two Posters from the Phase 2a RIVER Trial Data Will be Featured at the European Respiratory Society (ERS) Congress 2025 (PRNewswire)

P2a data • Chronic Cough

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

Stability and physical compatibility of parenteral nalbuphine hydrochloride during continuous infusion in pediatrics. (PubMed, PLoS One) - "Nalbuphine hydrochloride in NS was found to be compatible with several drugs, but was incompatible with furosemide and amphotericin B. Nalbuphine hydrochloride can be administered in pediatric practice using a syringe pump for 24 h. However, drug-drug incompatibilities need to be considered when it is administered through a multiport manifold or Y-site connection."

Journal • Pediatrics

Pseudomonas aeruginosa in dental unit waterlines: an emerging threat of virulence genes in healthcare-associated infections. (PubMed, BMC Oral Health) - "These findings highlight that DUWLs act as reservoirs for P. aeruginosa strains harboring multiple virulence genes associated with biofilm formation. Targeted strategies are urgently needed to disrupt both bacterial growth and gene expression, which could help reduce antibiotic resistance and improve infection control in dental care."

Journal • Infectious Disease

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

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