Medigen Vaccine Biologics and BlueWillow Biologics have partnered for development of S-2P-NE-01, an intranasal vaccine against the SARS-CoV-2 virus, the companies said. According to the announcement, the vaccine will include BlueWillow's NanoVax nasal vaccine adjuvant and Medigen's S-2P spike protein; preclinical studies in mice have shown that the combination … [Read more...] about BlueWillow and Medigen partner on development of intranasal vaccine to prevent COVID-19
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TFF and Felix Biotechnology sign letter of intent for proposed development of inhaled bacteriophage for the treatment of lung infections
TFF Pharmaceuticals and Felix Biotechnology have signed a non-binding letter of intent for a proposed agreement regarding development of an inhaled dry powder bacteriophage for the treatment of lung infections. Felix would need to successfully complete a Series A financing before entering into a definitive agreement, which would provide for Felix to make an upfront … [Read more...] about TFF and Felix Biotechnology sign letter of intent for proposed development of inhaled bacteriophage for the treatment of lung infections
TFF and Augmenta Bioworks partner on inhaled mAbs for COVID-19
TFF Pharmaceuticals and Augmenta Bioworks have announced a an agreement to collaborate on development of inhaled dry powder monoclonal antibodies (mAbs) for the treatment of COVID-19 based on Augmenta’s mAbs and TFF's thin film freezing particle technology. TFF will also have an option on two more Augmenta mAbs, which it could develop for the treatment of other … [Read more...] about TFF and Augmenta Bioworks partner on inhaled mAbs for COVID-19
Sorrento presents positive preclinical data for its intranasal neutralizing antibody against COVID-19
Sorrento Therapeutics said that its intranasal Covi-Drops (STI-2099) neutralizing antibody reduced the effects of SARS-CoV-2 infection in a hamster model, and the company is planning to submit an IND for a clinical trial of Covi-Drops this month. Hamsters receiving the intranasal antibody lost less weight than hamsters in the control group at day 5 post infection, and … [Read more...] about Sorrento presents positive preclinical data for its intranasal neutralizing antibody against COVID-19
Positive Phase 1 trial results for PIMS-E’s epinephrine DPI
PureIMS subsidiary PIMS-E has announced that a Phase 1 clinical trial of its epinephrine DPI demonstrated that the dry powder epinephrine was well tolerated with no serious adverse reactions and produced peak plasma concentrations at levels that should be effective within 5 minutes post inhalation. PIMS-E is developing the epinephrine inhaler for the treatment of … [Read more...] about Positive Phase 1 trial results for PIMS-E’s epinephrine DPI
Ampio initiates Phase 1 trial of inhaled Ampion in COVID-19 patients
Ampio Pharmaceuticals has announced the initiation of a Phase 1 trial of an inhaled formulation of its Ampion anti-inflammatory biologic; the company had announced plans for the trial in September 2020 after having said in March 2020 that it intended to develop nebulized Ampion for the treatment of respiratory distress due to COVID-19. The trial is expected to … [Read more...] about Ampio initiates Phase 1 trial of inhaled Ampion in COVID-19 patients
FDA clears Neuronasal IND for intranasal N-acetylcysteine
According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC for the treatment of mild traumatic brain injury (mTBI, or concussion) and expected a pilot study to begin the next month. The pilot study has … [Read more...] about FDA clears Neuronasal IND for intranasal N-acetylcysteine
Positive Phase 1 and Phase 2a results for clinical trials of Respira’s vardenafil DPI
Respira Therapeutics has announced that the results of Phase 1 and Phase 2a clinical studies of RT234-PAH dry powder vardenafil "support its further development as an as-needed (PRN) treatment that will allow patient-controlled dosing to acutely improve episodic symptoms and exercise capacity in pulmonary arterial hypertension (PAH) patients." The company is … [Read more...] about Positive Phase 1 and Phase 2a results for clinical trials of Respira’s vardenafil DPI
Avalyn announces results of Phase 1/2 study of inhaled pirfenidone in IPF patients
Avalyn Pharma said that idiopathic pulmonary fibrosis (IPF) patients who received the higher dose tested in a Phase 1/2 study of the company's AP01 pirfenidone inhalation solution "had a trend toward stabilization of lung function," while those on the lower dose continued a decline in lung function over 24 weeks. As a result, all of the patients who are continuing in … [Read more...] about Avalyn announces results of Phase 1/2 study of inhaled pirfenidone in IPF patients
Armata Pharmaceuticals announces plans for Phase 1b/2a trial of inhaled phage in CF patients
Armata Pharmaceuticals announced that it plans to initiate clinical development of inhaled AP-PA02, a phage cocktail the company is developing for the treatment of P. aeruginosa infections in cystic fibrosis patients. The SAD portion of the Phase 1b/2a SWARM-P.a. study is expected to begin by the end of 2020. Armata Pharmaceuticals CEO Todd R. … [Read more...] about Armata Pharmaceuticals announces plans for Phase 1b/2a trial of inhaled phage in CF patients