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
Medical
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
Meissa says preliminary data from Phase 1 trial of its intranasal COVID-19 vaccine look promising
Meissa Vaccines has announced that interim data from a Phase 1 study of its MV-014-212 intranasal recombinant live attenuated COVID-19 vaccine demonstrate that a single dose produced a good nasal IgA response with no reported safety issues. In July 2020, the company said that the Phase 1 trial had begun dosing subjects. According to the new announcement, the interim … [Read more...] about Meissa says preliminary data from Phase 1 trial of its intranasal COVID-19 vaccine look promising
Beckley Psytech initiates Phase 1 trial of intranasal 5-MeO-DMT
Beckley Psytech said that it has initiated dosing in a Phase 1 trial of its intranasal 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT), a psychedelic compound found in the secretions of certain toads. The company is developing the intranasal formulation for the treatment of treatment resistant depression (TRD). The single ascending dose study is expected to enroll up … [Read more...] about Beckley Psytech initiates Phase 1 trial of intranasal 5-MeO-DMT
Synairgen gets recommendation to advance its inhaled interferon for mild to moderate COVID-19 into Phase 3
According to Synairgen, the external data safety monitoring board (DSMB) for the ACTIV-2 study of the company's SNG001 nebulized interferon beta in mild to moderate COVID-19 patients has recommended that the company advance SNG001 into Phase 3. Synairgen said that it has not yet received any data from the ACTIV-2 trial. A Phase 3 trial of SNG001 in hospitalized … [Read more...] about Synairgen gets recommendation to advance its inhaled interferon for mild to moderate COVID-19 into Phase 3