Aerovate Therapeutics has initiated a Phase 2b/3 trial of its AV-101 imatinib DPI for the treatment of pulmonary arterial hypertension (PAH), the company said. The IMPAHCT trial is expected to enroll 462 PAH patients; the Phase 2b portion of the trial will evaluate three doses of AV-101 versus placebo to select a dose for the Phase 3 portion. Topline results from the … [Read more...] about Aerovate initiates Phase 2b/3 trial of AV-101 inhaled imatinib for PAH
Medical
ViraVac to develop intranasal COVID-19 vaccine based on Lancaster University technology
Lancaster University has announced that newly launched ViraCorp subsidiary ViraVac will develop a intranasal COVID-19 vaccine based on technology developed at Lancaster by Muhammad Munir, a lecturer in biomedicine. According to the announcement, "The company is set to announce a number of world-leading scientific partner organizations to take the vaccine through … [Read more...] about ViraVac to develop intranasal COVID-19 vaccine based on Lancaster University technology
McMaster University announces Phase 1 trial of two inhaled COVID-19 vaccines
McMaster University announced that Health Canada has cleared a Phase 1 trial of two inhaled adenovirus vector vaccines against SARS-CoV-2, and the study is set to begin shortly. The trial is expected to enroll at least 30 healthy volunteers who have already received two doses of an mRNA vaccine. Each of the participants will receive a single dose of one of the … [Read more...] about McMaster University announces Phase 1 trial of two inhaled COVID-19 vaccines
CF Foundation providing $3.5 million for development of Pulmocide’s inhaled opelconazole
The Cystic Fibrosis Foundation announced that it is providing $3.5 million for a Phase 2 study of Pulmocide Ltd's PC945 inhaled opelconazole for the prevention of pulmonary Aspergillus infections following lung transplantation. The CF Foundation noted that this is the organization's first investment in development of a drug specifically for treatment related to lung … [Read more...] about CF Foundation providing $3.5 million for development of Pulmocide’s inhaled opelconazole
Phase 3 trial of Biohaven’s intranasal zavegepant for migraine meets its primary endpoints
Biohaven Pharmaceutical said that a Phase 3 trial of its intranasal zavegepant (BHV-3500) for the treatment of moderate or severe migraine has met its primary endpoints, demonstrating statistically significant increase in freedom from both pain and most bothersome symptom compared to placebo. This is the second pivotal trial of intranasal zavegepant for migraine; in … [Read more...] about Phase 3 trial of Biohaven’s intranasal zavegepant for migraine meets its primary endpoints
FDA clears IND for Phase 2 study of Tonix’s intranasal oxytocin for the prevention of migraine
According to Tonix Pharmaceuticals, the FDA has cleared the company's IND for a Phase 2 study of TNX-1900 potentiated oxytocin nasal spray for the prevention of migraine headache. Tonix acquired the rights to the intranasal oxytocin for the treatment of migraine from Trigemina in June 2020 and says that it would plan to submit an NDA under the 505(b)(2) pathway. Over … [Read more...] about FDA clears IND for Phase 2 study of Tonix’s intranasal oxytocin for the prevention of migraine
Brigham and Women’s Hospital announces Phase 1 trial of intranasal vaccine for Alzheimer’s
Brigham and Women’s Hospital (BWH) has announced an upcoming clinical trial of an intranasal vaccine for the prevention and treatment of Alzheimer’s disease (AD). The SAD trial is expected to enroll 16 early-staged Alzheimer's patients aged 60-85 who will each get two doses of the vaccine, with the second dose administered one week following the first dose. The … [Read more...] about Brigham and Women’s Hospital announces Phase 1 trial of intranasal vaccine for Alzheimer’s
Phase 1 trial of Pneumagen’s Neumifil nasal spray gets underway
Pneumagen has announced the initiation of a Phase 1 SAD/MAD study of its Neumifil carbohydrate binding module (mCBM) nasal spray, which the company is developing for the prevention and treatment of viral respiratory infections. The company said that it expects topline results to be available in the first half of 2022. At the beginning of 2021, Pneumagen announced … [Read more...] about Phase 1 trial of Pneumagen’s Neumifil nasal spray gets underway
CF Foundation, Innoviva make equity investments in Armata Pharmaceuticals
Armata Pharmaceuticals announced that the Cystic Fibrosis Foundation has purchased $3 million worth of the company's common stock and that Innoviva subsidiary Innoviva Strategic Opportunities, which already held a significant number of shares in Armata, has invested a further $4 million. The funds will be used to support further development of the company's lead … [Read more...] about CF Foundation, Innoviva make equity investments in Armata Pharmaceuticals
Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide
According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF's dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers in the SAD phase and 3 and 6 mg doses twice a day for 5 days in the MAD phase. TFF said that it expects dosing to get underway in November 2021 and … [Read more...] about Health Canada clears Phase 1 trial of TFF’s dry powder niclosamide