Atossa Therapeutics announced that a two-week Phase 1 study evaluating the safety of two dose levels of the company's AT-301 nasal spray in healthy volunteers demonstrated that the nasal spray was safe and well tolerated. The company announced in August 2020 that it had received approval for the Phase 1 trial of AT-301, which it is developing as an at-home treatment … [Read more...] about Positive Phase 1 results for Atossa’s AT-301 nasal spray
Medical
Virpax begins pre-clinical studies of intranasal enkephalin to support IND
Virpax Pharmaceuticals said that the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health has begun pre-clinical studies of Virpax's Envelta intranasal enkephalin to support an IND submission. Virpax signed a cooperative research and development agreement with NCATS in August 2020. Envelta is delivered via a single use … [Read more...] about Virpax begins pre-clinical studies of intranasal enkephalin to support IND
Aridis announces planned clinical development of inhaled mAb cocktail for COVID-19
Aridis Pharmaceuticals announced that it is now receiving preclinical support from the NIAID (National Institute of Allergy and Infectious Diseases) and CoVIC (Coronavirus Immunotherapy Consortium) for a nebulized monoclonal antibody cocktail for COVID-19 and that it plans to initiate a Phase 1/2/3 clinical trial in the second half of this year. The company also said … [Read more...] about Aridis announces planned clinical development of inhaled mAb cocktail for COVID-19
Clinical trial of intranasal niclosamide for the prevention of COVID-19 gets underway
According to Union therapeutics, the Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge have begun recruiting kidney patients for a clinical trial of Union's UNI91103 intranasal niclosamide for the prevention of COVID-19 in vulnerable patients. The PROTECT-V (PROphylaxis for vulnerable paTiEnts at risk of COVID-19 infecTion) trial is … [Read more...] about Clinical trial of intranasal niclosamide for the prevention of COVID-19 gets underway
TFF Pharmaceuticals says it has formulated a dry powder mAb against Ebola and vaccine against equine encephalitis
TFF Pharmaceuticals said that in vitro testing has confirmed the efficacy of a monoclonal antibody against Ebolavirus Zaire and a recombinant vesicular stomatitis virus (rVSV) vaccine candidate against Venezuelan equine encephalitis virus formulated using the company's thin film freezing technology. According to TFF, the in vitro studies demonstrated that both the … [Read more...] about TFF Pharmaceuticals says it has formulated a dry powder mAb against Ebola and vaccine against equine encephalitis
Insmed says Phase 1 study of treprostinil palmitil inhalation powder supports once-daily dosing
Insmed Incorporated has announced data from a Phase 1 study of its treprostinil palmitil inhalation powder (TPIP) in healthy volunteers demonstrated that TPIP was generally safe and well tolerated and had a lower Cmax and longer half-life than Tyvaso. The study enrolled 42 subjects and evaluated doses as high as 225 µg for a repeated dose and 675 µg for a single … [Read more...] about Insmed says Phase 1 study of treprostinil palmitil inhalation powder supports once-daily dosing
CEBINA partners with Ursapharm Arzneimittel to develop azelastine nasal spray for the treatment of COVID-19
The Central European Biotech Incubator and Accelerator (CEBINA) has announced a partnership with Ursapharm Arzneimittel to repurpose Ursapharm's Pollival azelastine nasal spray for the treatment of COVID-19. In July 2020, CEBINA announced that it had filed a patent application for the use of azelastine to treat COVID-19 and that it was looking for partners … [Read more...] about CEBINA partners with Ursapharm Arzneimittel to develop azelastine nasal spray for the treatment of COVID-19
FDA clears Altimmune’s IND for AdCOVID intranasal vaccine
According to Altimmune, the FDA has now cleared the company’s IND for a Phase 1 trial of its AdCOVID intranasal vaccine candidate, and enrollment in the trial is expected to begin within a week. Altimmune initially submitted the IND in November 2020, and the FDA placed a clinical hold on the application in December 2020 citing the need for changes to the protocols … [Read more...] about FDA clears Altimmune’s IND for AdCOVID intranasal vaccine
Study finds that inhaled budesonide can reduce severity of and speed recovery from COVID-19
A Phase 2 study of inhaled budesonide for the treatment of COVID-19 found that patients who received 800 mcg twice daily plus standard of care within 7 days after first experiencing symptoms had a 90% reduced risk of urgent medical care or hospital admission compared to patients who did not get inhaled budesonide. The STOIC study enrolled 146 adult patients with early … [Read more...] about Study finds that inhaled budesonide can reduce severity of and speed recovery from COVID-19
NeuroRx initates Phase 2/3 trial of nebulized Zyesami aviptadil for the treatment of COVID-19
NeuroRx announced that it has initiated a Phase 2/3 clinical trial of nebulized Zyesami aviptadil (RLF-100) for the treatment of severe COVID-19. In August 2020, NeuroRx announced that the FDA had cleared an IND for the trial, which is being led by researchers from the University of California Irvine's UCI Health. Principal investigator Richard Lee, Interim Chief … [Read more...] about NeuroRx initates Phase 2/3 trial of nebulized Zyesami aviptadil for the treatment of COVID-19