Medical

Israel-based SpliSense said that it has initiated a Phase 1/2 trial of its SPL84 inhaled anti sense oligonucleotide for the treatment of cystic fibrosis associated with the 3849+10 kb C-to-T mutation. SPL84 has been granted Orphan Drug designation from both the EMA and the FDA. The company said that the SAD portion of the trial will evaluate SPL84 in healthy … [Read more...] about SpliSense initiates Phase 1/2 trial of SPL84 inhaled antisense oligonucleotide for CF

Verona Pharma announced that the Phase 3 ENHANCE-1 trial of nebulized ensifentrine for the treatment of COPD met its primary endpoint, demonstrating an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 87 ml at week 12, as well as consistent improvement for all subgroups. Patients receiving ensifentrine also had a 36% lower rate of moderate to severe … [Read more...] about Verona announces positive results from ENHANCE-1 Phase 3 trial of nebulized ensifentrine

Gossamer Bio has announced that the TORREY Phase 2 study of its GB002 seralutinib DPI for the treatment of pulmonary arterial hypertension (PAH) met its primary endpoint, demonstrating a statistically significant change in pulmonary vascular resistance (PVR) at Week 24. According to Gossamer, "Seralutinib is a tyrosine kinase inhibitor targeting PDGFRα/β, CSF1R, and … [Read more...] about Phase 2 study of Gossamer Bio’s Seralutinib DPI for PAH meets primary endpoint

Intravacc announced that it has initiated a Phase 1 trial of Avacc 10 intranasal SARS-CoV-2 subunit vaccine, which the company is developing as a booster. Avacc 10 is based on the same outer membrane vesicles (OMV) technology as the company's intranasal vaccines against gonorrhea and betacoronavirus vaccines. Intravacc had announced in June 2020 that it would develop … [Read more...] about Intravacc initiates Phase 1 trial of Avacc 10 intranasal vaccine as a COVID-19 booster

Aerovate Therapeutics has published data from a Phase 1 study of its AV-101 dry powder imatinib showing that the inhaled formulation resulted in significantly lower systemic exposure compared to oral imatinib. The company announced the initiation of the IMPAHCT trial Phase 2b/3 of AV-101 in patients with pulmonary arterial hypertension (PAH) in December 2021. The … [Read more...] about Aerovate Therapeutics publishes data from Phase 1 trial of AV-101 imatinib DPI

Beckley Psytech has announced that a Phase 1 SAD study of its BPL-003 intranasal dry powder synthetic 5-Methoxy-N, N-Dimethyltryptamine (5-MeO-DMT) found that the PK profile was dose proportional and consciousness altering effects of the drug were short-lived. The study enrolled 44 patients aged 25-55 who received single doses of BPL-003 up to 12 mg or placebo. The … [Read more...] about Beckley Psytech reports results from Phase 1 study of BPL-003 intranasal dry powder 5-MeO-DMT