Medical

Vistagen has announced the initiation of the Phase 3 PALISADE-3 public speaking trial of fasedienol (PH94B) nasal spray in people with social anxiety disorder. In August 2023, the company announced that the Phase 3 PALISADE-2 trial had met its primary endpoint although that study was closed early and enrolled only about 2/3 of the expected number of subjects. The … [Read more...] about Vistagen initiates Phase 3 PALISADE-3 trial of fasedienol nasal spray in people with social anxiety disorder

Beckley Psytech says that more than half of people with moderate-to-severe treatment resistant depression who received a single 10mg dose of BPL-003 intranasal synthetic dry powder 5-MeO-DMT (mebufotenin) in a Phase 2a trial experienced a reduction in depressive symptoms and almost half remained in remission at day 85 post dose. The Phase 2a study, which was initiated … [Read more...] about Beckley announces data from Phase 2a trial of BPL-003 intranasal dry powder synthetic 5-MeO-DMT in people with treatment resistant depression.

Intravacc has announced that a Phase 1 study of Avacc 10 intranasal vaccine as a booster against SARS-CoV-2 induced a mucosal response in subjects who received the higher of two doses tested, and the vaccine was well tolerated. The company announced in November 2022 that it was initiating the Phase 1 study of Avacc 10. According to Intravacc, the study enrolled 36 … [Read more...] about Intravacc announces data from Phase 1 study of Avacc 10 intranasal SARS-CoV-2 vaccine as a booster

Blue Lake Biotechnology has announced initial results from a Phase 1/2a clinical trial of its BLB201 intranasal vaccine against severe respiratory syncytial virus disease in children aged 8 months to 59 months with or without prior RSV infection. The company has previously announced results from a Phase 1 trial BLB201 in adults aged 18-59 and 60-75. In 2022, the FDA … [Read more...] about Blue Lake announces preliminary data from Phase 1/2a trial of BLB201 intranasal RSV vaccine in young children

Inhalon Biopharma announced that a Phase 1b study that evaluated the company's IN-006 nebulized regdanvimab in healthy volunteers demonstrated successful delivery of the inhaled antibodies throughout the respiratory tract, achieving uniform distribution and significantly higher concentrations than for intravenous regdanvimab. The study was funded by the United States … [Read more...] about Inhalon reports data from Phase 1b trial of IN-006 inhaled regdanvimab

TFF Pharmaceuticals says that it will prioritize development of TFF TAC inhaled dry powder tacrolimus for the prevention of lung transplant rejection after receiving positive data from an ongoing Phase 2 trial. The company will now de-prioritize development of TFF VORI inhaled dry powder voriconazole for the treatment of invasive pulmonary aspergillosis. According … [Read more...] about TFF says it will prioritize development of its tacrolimus DPI

Inhalon Biopharma has announced the publication of two articles that present data from preclinical studies of the company's inhaled "muco-trapping" technologies. The first, published in the journal Advanced Science, describes a study of nebulized delivery of Inhalon's Mota-MT antibody to the lungs of nonatal lambs infected with RSV. The second article, published … [Read more...] about Inhalon publishes data from preclinical studies of its inhaled muco-trapping therapies in RSV and SARS-CoV-2 models

AstraZeneca today announced the initiation of the Phase 3 ATHLOS and THARROS trials evaluating the effects of Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI on cardiopulmonary parameters and outcomes (including death) in COPD patients. Breztri was approved by the FDA for the treatment of COPD in July 2020. In August 2023, the agency issued a … [Read more...] about AstraZeneca initiates 2 Phase 3 trials investigating the effects of Breztri Aerosphere MDI on cardiopulmonary factors and outcomes in COPD patients