Medical

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

US-based startup Pocket Naloxone said that a human factors study of its NaxSwab OTC naloxone nasal swab demonstrated that the swab could be used effectively in a simulated emergency by a wide range of people, including adolescents. The company said that 41 of 45 lay people and 15 of 15 healthcare professionals who participated in the study were able to successfully … [Read more...] about Pocket Naloxone announces results of human factors study of its NaxSwab OTC naloxone nasal swab

Nuance Pharma has initiated the ENHANCE - China Phase 3 study of nebulized ensifentrine in mainland China, the company said. Nuance obtained the rights to develop and market ensifentrine in China, Macau, Taiwan, and Hong Kong from Verona Pharma in 2021 and in August 2022, the company said that the Chinese Center for Drug Evaluation had approved its IND for Phase 1 and … [Read more...] about Nuance Pharma initiates Phase 3 trial of nebulized ensifentrine for COPD in China

Tiziana Life Sciences says that after receiving feedback from the FDA following a Type C meeting, the company plans to move forward with a Phase 2 trial of intranasal foralumab, a human anti-CD3 mAb, in patients with non-active secondary progressive multiple sclerosis. In September 2019, Tiziana announced results from its Phase 1 trial of intranasal foralumab. Since … [Read more...] about Tiziana announces plans for Phase 2 trial of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis 

Avalyn Pharma has published data from its Phase 1b ATLAS study evaluating the safety of AP01 nebulized pirfenidone in patients with idiopathic pulmonary fibrosis over 72 weeks. In the article, the authors report that treatment-related adverse events were mild-to-moderate and less frequent than side effects associated with oral pirfenidone. They also reported that … [Read more...] about Avalyn reports data from Phase 1b study of AP01 inhaled pirfenidone in IPF patients

Vistagen said that a Phase 3 open label safety study of fasedienol (PH94B, aloradine) nasal spray for the treatment of social anxiety disorder (SAD) found that up to 4 daily doses of 3.2 µg was well-tolerated, with no new safety findings. The company said that on the secondary endpoint of change from baseline on the Liebowitz Social Anxiety Scale (LSAS), "Analysis of … [Read more...] about Vistagen announces results from Phase 3 safety trial of fasedienol (PH94B) nasal spray for social anxiety

Firebrick Pharma announced that it is re-starting a Phase 3 clinical trial of Nasodine povidone-iodine nasal spray as the 2023 common cold season begins in the Southern Hemisphere. According to the company, the trial, which is taking place in Australia and South Africa, was paused for the summer after having fulfilled half of its recruitment goal during the 2022 cold … [Read more...] about Firebrick Pharma restarts Phase 3 trial of Nasodine nasal spray for the common cold

Aridis Pharmaceuticals has announced that a Phase 2a study of the company's AR-501 nebulized gallium in cystic fibrosis patients with P. aeruginosa lung infections met its primary and secondary endpoints, with all 3 dose levels tested being well tolerated. According to Aridis, uptake of AR-501 in the respiratory track was up to 10 times higher than previously reported … [Read more...] about Phase 2a study of Aridis’s AR-501 inhaled gallium in CF patients meets primary and secondary endpoints