Trevi Therapeutics

First Ascent Biomedical Secures Florida Grant to Expand AI-Driven Cancer Treatment Platform

3 months ago

• First Ascent Biomedical's xDRIVE Drug Prediction Platform, showing 83% improvement in treatment outcomes, receives funding from Florida Cancer Innovation Fund to expand personalized cancer care access. • The AI-powered platform combines DNA/RNA sequencing, drug sensitivity testing, and machine learning to identify optimal treatments for cancer recurrence, with notable success in pediatric oncology. • The grant will support expanding treatment access to rural and minority communities in Florida, while advancing FDA Breakthrough Device Designation and insurance coverage approvals.

Medable Secures CNIL Approval for Digital Clinical Trial Solutions in European Union

3 months ago

• Medable Inc. has received CNIL approval to operate its eConsent and eCOA solutions in eight countries outside the EU, marking a significant expansion of digital clinical trial capabilities. • The company partnered with French pharmaceutical giant Servier to achieve this regulatory milestone, demonstrating platform validation and enhanced security measures through a rigorous six-month process. • Medable's digital platform has shown impressive results across 300+ trials globally, including 90% eCOA adherence and potential ROI of up to $39 million for Phase III trials.

Stifel Raises Price Target on Trevi Therapeutics as Haduvio Shows Promise for Chronic Cough Treatment

3 months ago

• Stifel investment bank has increased its price target for Trevi Therapeutics (TRVI) from $8 to $12, maintaining a Buy rating as the company approaches key trial data readout. • Haduvio, Trevi's mixed opioid drug, has demonstrated effectiveness in treating idiopathic pulmonary fibrosis-related chronic cough (IPF-CC), a condition resistant to other treatments. • The company's Phase 2b study for Haduvio in IPF-CC patients continues on track, with topline data expected in the first half of 2025.

Trevi Therapeutics' Haduvio Shows Promise for IPF-Related Cough Treatment, Receives Buy Rating

4 months ago

• Leerink Partners analyst maintains a Buy rating for Trevi Therapeutics with a $7.00 price target, citing Haduvio's potential in treating idiopathic pulmonary fibrosis (IPF) cough. • The upcoming Phase 2a RIVER study for refractory chronic cough (RCC) is anticipated to deliver positive results, potentially strengthening the company's market position. • IPF cough indication presents a clear commercial pathway with possible orphan drug designation, while expansion into RCC market faces competitive challenges requiring strong efficacy data.

Viking Therapeutics Initiates Phase 2 Trial of Oral VK2735 for Obesity

4 months ago

• Viking Therapeutics has commenced a Phase 2 clinical trial for oral VK2735, a dual GLP-1/GIP agonist, to treat obesity. • The VENTURE-Oral Dosing Trial will evaluate the safety, tolerability, pharmacokinetics, and weight loss efficacy over 13 weeks in approximately 280 adults. • Prior Phase 1 data showed promising weight reductions up to 8.2% and encouraging tolerability with the oral tablet formulation of VK2735. • Viking plans to initiate Phase 3 development for the subcutaneous formulation of VK2735 in the first half of 2025, following positive Phase 2 results.

Promising Clinical Results and Market Potential Drive Buy Rating for Oculis Holding

5 months ago

Oculis Holding (OCS) has been given a Buy rating by Stifel Nicolaus analyst Annabel Samimy, due to the promising clinical results of its drug OCS-05 in treating acute optic neuritis (AON). The drug showed significant improvements in anatomical and functional outcomes, with a positive safety profile and potential to reduce relapses in CNS inflammatory conditions. The FDA's clearance for its IND application supports its advancement into regulatory trials.

Boehringer Ingelheim's Nerandomilast Shows Promise in Phase III Trials for Pulmonary Fibrosis

5 months ago

• Boehringer Ingelheim's nerandomilast met its primary endpoint in the Phase III FIBRONEER-ILD trial, improving lung function in patients with progressive pulmonary fibrosis. • The company plans to submit a New Drug Application (NDA) to the FDA and other health authorities for nerandomilast in progressive pulmonary fibrosis. • Nerandomilast, an oral PDE4B inhibitor, has also shown positive results in a separate Phase III trial for idiopathic pulmonary fibrosis (IPF), with an NDA already submitted. • The FIBRONEER-ILD trial included 1,178 patients across 40 countries, evaluating two doses of nerandomilast against placebo over 52 weeks.

Trevi Therapeutics' Haduvio Phase 2b Trial for IPF-Related Chronic Cough Nears Completion

5 months ago

• Trevi Therapeutics' Phase 2b CORAL trial evaluating Haduvio for chronic cough in IPF patients has reached 75% enrollment, indicating strong progress. • The trial, involving 160 patients across 10 countries, is assessing the efficacy of three Haduvio doses versus placebo over six weeks. • Top-line data from the CORAL trial is anticipated in the first half of 2025, offering hope for a potential first-in-class treatment. • A prior Phase 2a trial demonstrated Haduvio's significant reduction in cough frequency in IPF patients, supporting further investigation.

Trevi Therapeutics' Oral Nalbuphine Demonstrates Reduced Abuse Potential in Clinical Study

6 months ago

• Trevi Therapeutics' oral nalbuphine showed statistically significant lower "Drug Liking" compared to IV butorphanol in a human abuse potential (HAP) study. • The study assessed three doses of oral nalbuphine (81mg, 162mg, 486mg) against IV butorphanol and placebo in recreational drug users. • Secondary endpoints were consistent with the primary endpoint, with no serious adverse events reported during the study. • These results support nalbuphine's potential as a non-scheduled option for chronic cough without the abuse risks of traditional opioids.

Roflumilast Cream Shows High Efficacy in Treating Atopic Dermatitis in Adults and Children

6 months ago

• Roflumilast cream 0.15% demonstrated significantly higher efficacy than the vehicle in achieving a validated IGA-AD score of 0/1 in patients with atopic dermatitis. • The study found that over 95% of patients treated with roflumilast cream reported no signs of application site irritation, highlighting its tolerability. • Roflumilast significantly improved EASI 75 scores compared to the vehicle, indicating a substantial reduction in eczema severity among treated patients. • This once-daily, nonsteroidal cream addresses key unmet needs in atopic dermatitis treatment, potentially improving patient adherence and outcomes.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Trevi Therapeutics Announces Clinical Trial Progress for Haduvio in Chronic Cough

8 months ago

• Trevi Therapeutics' Phase 2b CORAL trial for chronic cough in IPF reaches 50% enrollment; sample size re-estimation results are expected in December 2024. • Dosing is complete in the Human Abuse Potential (HAP) study for Haduvio, with topline results also anticipated in December 2024. • The Phase 2a RIVER trial for refractory chronic cough has reached its planned sample size, with topline results expected in Q1 2025.