Virpax Pharmaceuticals said that it is encouraged by the FDA response to its IND for MMS019 "high-density molecular masking spray" which the company is developing as an anti-viral barrier. According to Virpax, the company now intends to begin clinical development with the goal of submitting an NDA for MMS019 to the FDA's Office of Non-Prescription Drugs. The company … [Read more...] about Virpax says it intends to submit NDA for its MMS019 nasal spray as an OTC anti-viral barrier
Medical
Positive results from pilot study of Tiziana’s intranasal Foralumab in mild to moderate COVID-19
Tiziana Life Sciences has published results from a pilot study of its intranasal Foralumab in mild to moderate COVID-19 demonstrating that nasal administration of the human anti-CD3 monoclonal antibody was well tolerated and significantly reduced lung inflammation in non-hospitalized patients. In 2019, the company announced positive Phase 1 results for the intranasal … [Read more...] about Positive results from pilot study of Tiziana’s intranasal Foralumab in mild to moderate COVID-19
Positive preclinical results for ReCode Therapeutics’ inhaled mRNA therapy for primary ciliary dyskinesia
According to ReCode Therapeutics, studies of its nebulized lipid nanoparticle DNAI1 mRNA therapy for the treatment of primary ciliary dyskinesia in non-human primates demonstrated that a single dose of the mRNA could be delivered successfully for good distribution in the lungs. Along with the in vivo studies, tests in human and mouse cell models confirmed that DNAI1 … [Read more...] about Positive preclinical results for ReCode Therapeutics’ inhaled mRNA therapy for primary ciliary dyskinesia
Insmed launches Arikayce in Japan, advances TPIP into Phase 2 trials
According to an Insmed update, the company launched recently launched Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in Japan. The Japanese Ministry of Health, Labour and Welfare approved Arikayce for that indication in March 2021. The company also … [Read more...] about Insmed launches Arikayce in Japan, advances TPIP into Phase 2 trials
Satsuma initiates new Phase 3 trial of STS101 intranasal DHE powder for migraine
Satsuma Pharmaceuticals has initiated the SUMMIT Phase 3 trial of its STS101 dihydroergotamine (DHE) nasal powder for the treatment of migraine, the company said. A previous Phase 3 trial of STS101 called EMERGE failed to meet its primary endpoints. Topline data from the SUMMIT trial are expected in the second half of 2022. The SUMMIT trial is expected to enroll … [Read more...] about Satsuma initiates new Phase 3 trial of STS101 intranasal DHE powder for migraine
In vitro tests show Augmenta/TFF dry powder mAb neutralizes SARS-C0V-2 Delta variant
Augmenta Bioworks and TFF Pharmaceuticals have announced that in vitro testing of their AUG-3387 dry powder monoclonal antibody has demonstrated that the mAb neutralizes the SARS-CoV-2 Delta variant, the highly transmissible strain that is currently dominant in numerous countries. In vitro tests had already demonstrated that the mAb could be effective against other … [Read more...] about In vitro tests show Augmenta/TFF dry powder mAb neutralizes SARS-C0V-2 Delta variant
Positive results for Phase 1 trial of CanSinoBio inhaled COVID-19 vaccine
Results from a Phase 1 trial of an inhaled version of CanSino Biologic's Ad5-nCoV vaccine against COVID-19 have been published online in The Lancet Infectious Diseases. The study enrolled 130 healthy volunteers who got either intramuscular Ad5-nCoV, two doses of aerosolized vaccine, or IM vaccine with an aerosolized booster and found that the nebulized vaccine was … [Read more...] about Positive results for Phase 1 trial of CanSinoBio inhaled COVID-19 vaccine
Inhaled dry powder tamibarotene effective against respiratory viruses in preclinical studies
Preclinical studies by researchers from the LKS Faculty of Medicine at The University of Hong Kong have demonstrated that a dry powder formulation of tamibarotene delivered to the lungs of hamster and mice has broad activity against respiratory viruses, including SARS-CoV-2, MERS-CoV, and influenza A H1N1. Results from the studies were published in Advanced … [Read more...] about Inhaled dry powder tamibarotene effective against respiratory viruses in preclinical studies
Sorrento initiates Phase 2 trial of its intranasal neutralizing antibody against COVID-19
Sorrento Therapeutics has initiated a Phase 2 trial of its CoviDrops intranasal neutralizing antibody in COVID-19 patients in the UK, the company said. The trial is expected to enroll 350 COVID-19 patients who have mild symptoms or are asymptomatic who will get either 10 mg or 20 mg of CoviDrops via nasal instillation or placebo. Treatment and assessment will take … [Read more...] about Sorrento initiates Phase 2 trial of its intranasal neutralizing antibody against COVID-19
Celltrion, Inhalon partner on inhaled regdanvimab for COVID-19
Inhalon Biopharma has announced that it is partnered with Celltrion to develop a nebulized formulation of regdanvimab, a monoclonal antibody for the treatment of COVID-19, which will be known as IN-006. In May 2021, Inhalon announced that it had been awarded a US Army contract worth $7 million for development of IN-006. The company says that a Phase 1 study of IN-006 … [Read more...] about Celltrion, Inhalon partner on inhaled regdanvimab for COVID-19