Medical

Mundipharma has announced enrollment of the first patient in the Phase 3b METEORA trial of Penthrox inhaled methoxyflurane in patients with limb trauma who have been rescued by helicopter from hostile terrain and are suffering from moderate-to-severe pain. The study is expected to enroll 200 adult patients rescued by Italian helicopter emergency medical services, … [Read more...] about Mundipharma initiates Phase 3 trial of Penthrox in trauma patients rescued from hostile environments

Breath Therapeutics has announced the initiation of Phase 3 studies of its L‑CsA‑i inhaled liposomal cyclosporine A for the treatment of bronchiolitis obliterans. Breath Therapeutics licensed L-CsA-i from PARI in 2017, and the drug is delivered via PARI's eFlow nebulizer. The 48-week BOSTON-1 and BOSTON-2 studies are each expected to enroll 110 lung transplant … [Read more...] about Breath Therapeutics initiates Phase 3 trials of nebulized liposomal cyclosporine A for bronchiolitis obliterans

Liquidia Technologies has announced that the Phase 3 INSPIRE study of its LIQ861 DPI in pulmonary arterial hypertension (“PAH”) patients met its primary endpoint. In January 2019, the company announced encouraging preliminary results from the study. According to Liquidia, the 2-month study, which enrolled 109 patients, demonstrated that doses of up to 150 mcg of … [Read more...] about Phase 3 trial of Liquidia’s inhaled treprostinil meets primary endpoint

Verona Pharma said that it plans to initiate the second phase of a two-part Phase 2 trial of its RPL554 ensifentrine DPI in COPD patients after the first part of the study demonstrated that the DPI produced significant improvement in FEV1. The company announced initiation of the study in December 2018. The Phase 2 study enrolled 37 moderate-to-severe COPD patients … [Read more...] about Verona announces positive interim data from Phase 2 study ensifentrine DPI

Satsuma Pharmaceuticals, which was spun out from SNBL in 2017 specifically for the purpose of developing STS 101 intranasal dihydroergotamine (DHE) for the treatment of migraine, said that a Phase 1 clinical trial demonstrated that STS101 was well tolerated, with none of the typical side effects of injected DHE such as nausea and vomiting. STS101 was rapidly absorbed … [Read more...] about Satsuma announces Phase 1 results, plans for Phase 3 trial of its intranasal DHE for the treatment of migraine

FluGen has announced that preliminary data from a Phase 2 trial show that its intranasal M2SR manufactured with a strain of influenza that was used in vaccines during the 2008-2010 influenza seasons protected against a live H3N2 influenza virus from the 2014-15 flu season. Demonstrating protection against the highly mismatched virus is a "major step toward … [Read more...] about Phase 2 trial of FluGen intranasal flu vaccine demonstrates protection against highly mismatched virus