Synairgen has announced that the Phase 2 ACTIV-2 trial of SNG001 inhaled interferon-beta-1a in non-hospitalized COVID-19 patients failed to show a statistically significant reduction in hospitalization, viral load, safety, or resolution of symptoms compared to placebo, but the study did demonstrate a relative reduction of 86% in hospitalization. Over the course of the … [Read more...] about Synairgen announces top-line data from Phase 2 ACTIV-2 trial of SNG001 nebulized interferon-beta-1a for mild-to-moderate COVID-19
Medical
Odyssey Health says Phase 1 results for PRV-002 intranasal therapy for concussion support advancing the nasal powder to Phase 2
Odyssey Health announced that it has completed its Phase 1 study of PRV-002, a novel intranasal synthetic neurosteroid powder formulation that the company is developing for the treatment of concussion, and said that the results support advancing PRV-002 into Phase 2 trials. Odyssey acquired PRV-002 from Prevacus in January 2021. The company recently announced that the … [Read more...] about Odyssey Health says Phase 1 results for PRV-002 intranasal therapy for concussion support advancing the nasal powder to Phase 2
Wake Forest University School of Medicine gets Alzheimer’s Association grant for Phase 2 trial of intranasal insulin
According to Atrium Health Wake Forest Baptist, Wake Forest University School of Medicine has received a two-year $795,000 grant from the Alzheimer’s Association to support a Phase 2 trial of empagliflozin and intranasal insulin for Alzheimer's disease. The trial will be led by Wake Forest professor Suzanne Craft, who is director of the Alzheimer's Disease Research … [Read more...] about Wake Forest University School of Medicine gets Alzheimer’s Association grant for Phase 2 trial of intranasal insulin
United Therapeutics stops Phase 3 PERFECT trial of Tyvaso inhalation solution in PH-COPD patients
On a form 8-k filed with the US Securities and Exchange Commission (SEC), United Therapeutics reported the following: "On September 20, 2022, United Therapeutics Corporation (the Company) announced the termination of the PERFECT clinical study evaluating Tyvaso (treprostinil) Inhalation Solution for the treatment of pulmonary hypertension associated with chronic … [Read more...] about United Therapeutics stops Phase 3 PERFECT trial of Tyvaso inhalation solution in PH-COPD patients
Synairgen to present data showing its SNG001 nebulized interferon-beta-1a may reduce the risk of long COVID symptoms
Synairgen announced that it will present data from the Phase 3 SPRINTER trial of its SNG001 nebulized interferon-beta-1a in hospitalized COVID-19 patients at an upcoming meeting showing that treatment with SNG001 reduced symptoms of long COVID at 60 and 90 days post treatment compared to placebo. According to the data provided, patients treated with SNG001 had a 28.3% … [Read more...] about Synairgen to present data showing its SNG001 nebulized interferon-beta-1a may reduce the risk of long COVID symptoms
Satsuma announces data from the Phase 3 ASCEND trial of STS101 DHE migraine using second generation nasal delivery device
Satsuma Pharmaceuticals announced that data from a portion of the Phase 3 ASCEND trial of the company's STS101 dihydroergotamine (DHE) nasal powder where STS101 was delivered via a second generation device for the treatment of migraine did not reveal any significant safety concerns. Satsuma also said that efficacy was improved when subjects used the new device … [Read more...] about Satsuma announces data from the Phase 3 ASCEND trial of STS101 DHE migraine using second generation nasal delivery device
Startup Moat Biotechnology announces funding round, positive interim Phase 1 results for its intranasal COVID-19 vaccine
Startup Moat Biotechnology announced the initiation of a funding round led by Cortado Ventures that aims to raise up to $20 million for continued development of the company's intranasal vaccine against COVID-19. According to the announcement, Tetherex Pharmaceuticals has spun out MoatBio in order to develop single-cycle adenovirus vaccines based on SC-AdVax … [Read more...] about Startup Moat Biotechnology announces funding round, positive interim Phase 1 results for its intranasal COVID-19 vaccine
ALS Association to fund preclinical study of intranasal foralumab
According to Tiziana Life Sciences, The ALS Association will award a Lawrence & Isabel Barnett Drug Development Program Grant to the Ann Romney Center for Neurologic Diseases at the Brigham and Women’s Hospital (BWH) for a preclinical study of Tiziana's intranasal foralumab anti-CD3 monoclonal antibody. The company said that researchers at BWH will evaluate the … [Read more...] about ALS Association to fund preclinical study of intranasal foralumab
Bryn Pharma says results from a pivotal study of Utuly epinephrine nasal spray are encouraging
Bryn Pharma said that it has completed a pivotal study of its Utuly (BRYN-NDS1C) epinephrine nasal spray comparing PK/PD profiles of Utuly to a 0.3 mg dose of epinephrine delivered by autoinjector. According to the company's web site, Bryn is pursuing the 505(b)(2) NDA pathway with Mylan's EpiPen as the reference listed drug. In 2020, Bryn announced that it had raised … [Read more...] about Bryn Pharma says results from a pivotal study of Utuly epinephrine nasal spray are encouraging
Vistagen to continue Phase 3 PALISADE-2 trial of PH94B nasal spray
Vistagen Therapeutics has announced that it will restart the Phase 3 PALISADE-2 trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder (SAD), which the company had paused after the PALISADE-1 trial failed to meet its primary endpoint. According to Vistagen, an independent interim analysis of unblinded data from 140 subjects from … [Read more...] about Vistagen to continue Phase 3 PALISADE-2 trial of PH94B nasal spray