Medical

Researchers from the University of Texas at Austin and Chungnam National University have published in vitro and in vivo data demonstrating that a dry powder formulation of niclosamide that includes human lysozyme (hLYS) as a carrier exhibits potent activity against both the MERS-CoV and SARS-CoV-2 viruses. The article is available as a preprint on BioRxiv and is … [Read more...] about Studies show spray dried niclosamide/hLYS formulation has strong activity against SARS-CoV-2

Ena Respiratory (formerly Innavac) said that its INNA-051 pegylated TLR2/6 agonist nasal spray reduced replication of the SARS-CoV-2 virus in a ferret model by up to 96% in a study conducted by researchers at Public Health England. The company also announced that it has raised AU$11.7 million in Series A financing for a clinical trial that could begin by early 2021 … [Read more...] about Preclinical testing demonstrates that Ena Respiratory’s intranasal antiviral reduces replication of SARS-CoV-2

TFF Pharmaceuticals is drawing attention to in vitro data published by researchers at the University of Texas Austin which found that thin film freezing "produces high potency remdesivir dry powder formulations for inhalation suitable to treat patients with COVID-19 on an outpatient basis and earlier in the disease course where effective antiviral therapy can reduce … [Read more...] about UT Austin study concludes that TFF dry powder remdesivir is suitable as an inhaled therapy for COVID-19

Neurelis has announced plans to conduct a clinical trial of Valtoco diazepam nasal spray in children with epilepsy aged 2-5 and said that the company intends to file an sNDA to expand the use of Valtoco to include this population sometime in 2021. The FDA approved Valtoco for the treatment of seizure clusters in patients 6 years old and older in January 2020 and … [Read more...] about Neurelis announces clinical trial of Valtoco in epilepsy patients aged 2-5

Ampio Pharmaceuticals said that the FDA has cleared its IND for clinical trials of an inhaled formulation of its Ampion anti-inflammatory biologic in patients with COVID-19. The company had announced its plans to develop Ampion for the treatment of COVID-19 in March 2020. According to Ampio, preclinical toxicology studies demonstrated that Ampion would be safe for … [Read more...] about Ampio announces planned Phase 1 trial of inhaled Ampion in COVID-19 patients

TFF Pharmaceuticals has announced that it will advance its voriconazole inhalation powder into Phase 2 development for the treatment of invasive pulmonary aspergillosis following completion of a Phase 1 trial that demonstrated plasma levels that should be sufficient for effective treatment. Topline safety results from the trial were reported in June 2020, and in July, … [Read more...] about TFF to advance its dry powder voriconazole to Phase 2 after successful Phase 1 trial

Satsuma Pharmaceuticals said that the Phase 3 EMERGE trial of its STS101 dihydroergotamine nasal powder for the treatment of migraine failed to demonstrate statistically significant improvement in either pain relief or the patient's most bothersome symptom compared to placebo for either of the doses tested at two hours post dosing. The company had announced the … [Read more...] about Phase 3 trial of Satsuma’s DHE nasal powder for migraine fails to meet primary endpoints