Medical

Neurelis said that it has initiated the Stellina Phase 1/2a trial of Valtoco diazepam nasal spray in epilepsy patients between the ages of 2 and 5. The news comes almost exactly one year after the company announced plans for the pediatric trial and a future sNDA submission. Valtoco has been approved in the US for the treatment of seizure clusters in patients 6 years … [Read more...] about Neurelis initiates Phase 1/2a study of Valtoco nasal spray in pediatric epilepsy patients

Kinaset Therapeutics said that dosing is underway in a Phase 1b SAD/MAD study of its KN-002 dry powder JAK inhibitor, which it is developing for the treatment of asthma and COPD. The trial is expected to enroll 48 healthy volunteers in the single ascending dose portion of the study and 32 asthma patients in the multiple ascending dose part of the study. The … [Read more...] about Kinaset initiates Phase 1b trial of its KN-002 dry powder JAK inhibitor

VistaGen Therapeutics said that it has initiated the PALISADE-2 Phase 3 clinical trial of its PH94B aloradine nasal spray for the treatment of social anxiety disorder (SAD). The company initiated the PALISADE-1 trial of PH94B for SAD in May 2021. Topline results from that trial are expected in mid-2022, with results from the PALISADE-2 trial expected later that … [Read more...] about VistaGen initiates second Phase 3 study of PH94B nasal spray for the treatment of social anxiety disorder

AstraZeneca has announced that the Phase 3 MANDALA and DENALI trials of PT027 albuterol (salbutamol)/budesonide MDI for the treatment of asthma both met their primary endpoints. The company has been co-developing PT027 with Avillion since 2018. The MANDALA trial, which enrolled 3,132 patients who were using inhaled corticosteroids for moderate to severe asthma, … [Read more...] about Positive results for two Phase 3 studies of AstraZeneca’s PT027 albuterol/budesonide MDI

Zambon has presented results from its Phase 3 PROMIS-I study of CMS colistimethate sodium powder demonstrating that a CMS solution delivered via the Philips I-neb nebulizer significantly reduced exacerbations in patients with non-cystic fibrosis bronchiectasis (NCFB) and chronic P. aeruginosa lung infections. The company received Fast Track and QIDP designations for … [Read more...] about Phase 3 trial of nebulized colistimethate sodium in patients with bronchiectasis and P. aeruginosa infection meets primary endpoint

Nocion Therapeutics has dosed the first 10 subjects in a Phase 2a study of NOC-100, an inhaled formulation of its NTX-1175, a charged sodium channel blocker, the company said. Nocion is developing NTX-1175 for the treatment of chronic and acute cough, including cough resulting from COVID-19. According to the company, a Phase 1 study of inhaled NTX-1175 was completed … [Read more...] about Nocion Therapeutics announces Phase 2a trial of inhaled NTX-1175 charged sodium channel blocker for chronic cough

Receptor Life Sciences (RLS) has published data from a Phase 1 PK trial of its RLS103 dry powder cannabidiol (CBD) in the Journal of Pharmaceutical Sciences demonstrating significantly greater bioavailability for the inhaled CBD than for Epidiolex oral CBD solution. RLS announced completion of its pre-IND meeting with the FDA in January 2021. Receptor licensed … [Read more...] about Positive Phase 1 results for Receptor Life Sciences’ RLS103 CBD DPI

Tiziana Life Sciences has published results from a pilot study of its intranasal Foralumab in mild to moderate COVID-19 demonstrating that nasal administration of the human anti-CD3 monoclonal antibody was well tolerated and significantly reduced lung inflammation in non-hospitalized patients. In 2019, the company announced positive Phase 1 results for the intranasal … [Read more...] about Positive results from pilot study of Tiziana’s intranasal Foralumab in mild to moderate COVID-19

According to ReCode Therapeutics, studies of its nebulized lipid nanoparticle DNAI1 mRNA therapy for the treatment of primary ciliary dyskinesia in non-human primates demonstrated that a single dose of the mRNA could be delivered successfully for good distribution in the lungs. Along with the in vivo studies, tests in human and mouse cell models confirmed that DNAI1 … [Read more...] about Positive preclinical results for ReCode Therapeutics’ inhaled mRNA therapy for primary ciliary dyskinesia