Marinomed Biotech has announced plans for a Phase 4 trial of Carragelose iota-carrageenan nasal spray in healthcare professionals in contact with COVID-19 patients to study the ability of the nasal spray to reduce symptoms of viral respiratory infections, including SARS-CoV-2. The nasal spray is marketed as "Coldmaris Pro" in Austria, where the study will take … [Read more...] about Marinomed announces planned Phase 4 trial of Carregelose nasal spray for COVID-19
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Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT
Milestone Pharmaceuticals has announced the initiation of the RAPID Phase 3 trial of etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). A previous Phase 3 trial, NODE-301, failed to meet its primary endpoint. In July 2020, Milestone announced that it had reached an agreement with the FDA on the design of the RAPID study … [Read more...] about Milestone initiates new Phase 3 trial of etripamil nasal spray for PSVT
Revelation Biosciences initiates Phase 1 trial of REVTx-99 intranasal PHAD
Revelation Biosciences, which announced in October 2020 that the TGA had approved plans for a Phase 1 study of its REVTx‑99 intranasal phosphorylated hexaacylated disaccharide (PHAD), said that it has now initiated the trial. According to the company, 8 healthy volunteers have already received either REVTx-99 or placebo in the single ascending dose study, which is … [Read more...] about Revelation Biosciences initiates Phase 1 trial of REVTx-99 intranasal PHAD
BlueWillow and Medigen partner on development of intranasal vaccine to prevent COVID-19
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
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