Medical

Codagenix announced that it has initiated a Phase 1 study of its CodaVax-RSV live-attenuated intranasal vaccine candidate in children aged 6 months to 5 years, with the study expected to enroll 18 children aged 2 to 5 years and 33 children aged less than 2 years. The FDA cleared an IND for the study in mid-2022. A previous Phase 1 study evaluated the nasal spray in … [Read more...] about Codagenix initiates pediatric Phase 1 trial of CodaVax-RSV intranasal vaccine for the prevention of RSV

Zambon has announced that the Phase 3 BOSTON-1 and BOSTON-2 trials of liposomal cyclosporine A for inhalation (L-CsA-i) have completed enrollment. The two trials were initiated by Breath Therapeutics in March 2019 prior to that company's acquisition by Zambon. Breath Therapeutics was spun off from PARI Pharma in 2017 to develop L‑CsA‑i, which has received Fast Track … [Read more...] about Zambon announces completion of enrollment in Phase 3 studies of inhaled liposomal cyclosporine A for the treatment of BOS

Arrowhead Pharmaceuticals said that interim data from the ARORAGE-1001 Phase 1/2a trial of its ARO-RAGE inhaled RNAi therapeutic, which it is developing for the treatment of inflammatory lung diseases, demonstrate reductions in soluble receptor for advanced glycation end products (RAGE) as high as 90% in healthy volunteers at the 4th highest dose with no indications … [Read more...] about Arrowhead reports interim data from Phase 1/2a trial of ARO-RAGE inhaled RNAi for lung diseases

Tiziana Life Sciences has announced plans for development of its foralumab intranasal anti-CD3 monoclonal antibody for two additional indications, Type 1 diabetes and Alzheimer's disease. Tiziana said that it is initiating a development program for diabetes and that it plans to submit an IND for clinical development of foralumab in patients with Alzheimer's in the … [Read more...] about Tiziana announces plans for development of intranasal foralumab for diabetes, Alzheimer’s

Vyne Therapeutics said that an inhaled formulation of its VYN201 pan-BET inhibitor significantly reduced lung fibrosis and hydroxyproline levels in a mouse model of idiopathic pulmonary fibrosis (IPF) at doses of 0.5 mg/ml and 1 mg/ml, and functional lung volume and blood oxygen saturation were significantly improved. A topical formulation of VYN201 is currently in … [Read more...] about Vyne announces preclinical data for inhaled VYN201 in mouse model of IPF

Leyden Laboratories has initiated a Phase 1 trial of its intranasal PanFlu CR9114 anti-hemagglutinin stem human antibody in healthy volunteers, the company said. In July 2021, Leyden Labs announced that it had partnered with Nanopharm on development of intranasal formulations for Phase 1 studies. According to Leyden Labs, preclinical studies of CR9114 in animal models … [Read more...] about Leyden Labs initiates Phase 1 trial of PanFlu CR9114 nasal spray

Renovion has initiated a Phase 3 clinical study of its ARINA-1 inhaled glutathione / bicarbonate / ascorbic acid for the treatment of bronchiolitis obliterans syndrome (BOS) following bilateral lung transplant. ARINA-1 recently received Fast Track designation for that indication. Plans for the Phase 3 trial were announced in August 2022. According to the company, the … [Read more...] about Renovion initiates Phase 3 trial of ARINA-1 nebulized mucolytic in patients who have had a bilateral lung transplant

Tonix Pharmaceuticals said that it will reduce enrollment in the recently initiated Phase 2 PREVENTION study of TNX-1900 intranasal potentiated oxytocin in migraine patients from about 300 subjects to about 150 subjects, with a goal of providing topline data by the end of 2023. As part of the company's efforts to "streamline" two of its clinical trials, a Phase 3 … [Read more...] about Tonix will modify Phase 2 study of TNX-1900 intranasal potentiated oxytocin for the treatment of migraine