Medical

Engage Therapeutics said that the Phase 2b StATES (Staccato Alprazolam Terminates Epileptic Seizures) trial of Staccato inhaled alprazolam in epilepsy patients has met its primary endpoint, terminating seizure activity within two minutes of dosing with no recurrence in 50 of 76 patients. Engage had announced the initiation of the study in April … [Read more...] about Engage Therapeutics reports positive results from Phase 2 study of Staccato alprazolam for epileptic seizures

Otitopic announced that it has held discussions with the FDA regarding a pivotal PK/PD study of its Asprihale aspirin dry powder inhaler and now expects to initiate the study in the fourth quarter of 2020. Results are expected by the end of 2021, the company said. Otitopic is developing Asprihale for the treatment of myocardial infarction and has indicated that it … [Read more...] about Otitopic announces planned PK/PD study of its Asprihale aspirin DPI

United Therapeutics has announced that the Phase 3 INCREASE study of Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) met its primary endpoint, demonstrating statistically significant improvement in six-minute walk distance (6MWD).  All secondary endpoints for the study were also … [Read more...] about Phase 3 trial of Tyvaso inhaled treprostinil in patients with PH-ILD meets primary endpoint

Breath Therapeutics, which was acquired by Zambon in July 2019, said that it has initiated two new trials of its liposomal cyclosporine A for inhalation (L-CsA-i) for the treatment of bronchiolitis obliterans syndrome (BOS). BOSTON-3 is open-label extension study of the Phase 3 BOSTON-1 and BOSTON-2 studies of L-CsA-i for the treatment of BOS after a lung transplant … [Read more...] about Breath Therapeutics initiates additional studies of inhaled liposomal cyclosporine A for bronchiolitis obliterans

Seurat Therapeutics has published data from studies of its intranasal IGF-1 in rat models for the treatment of migraine in the journal Brain Research. The studies were conducted at the University of Chicago, which has licensed patents for the use of nasal IGF-1 to treat migraines to Seurat. According to the article, the formulation demonstrated the potential of … [Read more...] about Seurat reports data from preclinical studies of intranasal IGF-1

Pulmotect has announced that preclinical testing in mouse models has demonstated that a single dose of its PUL-042 inhaled immunostimulant, which is made up of Toll-like receptor ligands, could protect against infection by SARS-associated coronavirus and by MERS-associated coronavirus. Post-infection, PUL-042 also reduced the amount of virus in the lungs for both of … [Read more...] about Pulmotect says that preclinical testing of its PUL-042 inhaled immune stimulant shows potential against coronavirus infections

Verona Pharma said that a Phase 2b dose-ranging study of its RPL554 nebulized ensifentrine as an add on to tiotropium for the treatment of COPD met its primary endpoint at all doses tested. The company had announced initiation of the study in May 2019. The 4 week study, which enrolled 416 moderate-to-severe COPD patients, compared 0.375 mg, 0.75 mg, 1.5 mg, and … [Read more...] about Positive results for Phase 2b trial of nebulized ensifentrine as add-on to tiotropium

According to Oyster Point Pharma, the Phase 2 MYSTIC study of its OC-01 varenicline nasal spray for the treatment of dry eye disease met its primary endpoint, demonstrating significant improvement in tear production at Day 84 compared to control as measured by Schirmer's score. Both doses tested met that endpoint, with a 1.2 mg/ml dose achieving an 11.0 mm mean change … [Read more...] about Phase 2 study of Oyster Point’s OC-01 nasal spray for dry eye disease meets primary endpoint