According to Nuance Pharma, the Chinese Center for Drug Evaluation has approved the company's IND, allowing for a Phase 3 trial of nebulized ensifentrine, a PDE3/PDE4 inhibitor for the treatment of COPD, in China. The IND also grants approval for a Phase 1 PK study in healthy volunteers that the company plans to conduct in China. Nuance acquired the Chinese rights to … [Read more...] about Nuance Pharma gets the go-ahead for clinical trials of nebulized ensifentrine in China
Medical
NIH announces availability of licensing for IP related to nebulized thrombin inhibitors for the treatment of SARS-CoV-2-induced lung fibrosis
The US National Institutes of Health (NIH) has published a notice in the Federal Register regarding the availability of intellectual property related to the use of inhaled thrombin inhibitors for the treatment of lung fibrosis caused by SARS-CoV-2 infection. The notice says that the technology "is available for licensing to achieve expeditious commercialization of … [Read more...] about NIH announces availability of licensing for IP related to nebulized thrombin inhibitors for the treatment of SARS-CoV-2-induced lung fibrosis
Pneumagen initiates Phase 2 challenge study of Neumifil nasal spray against flu
Pneumagen announced the initiation of a Phase 2 challenge study of its Neumifil multivalent carbohydrate binding module (mCBM) nasal spray, which is the company is developing as a universal treatment for influenza, RSV, and COVID-19. The Phase 2 trial is expected to enroll up to 100 subjects who will receive one of two dose levels of Neumifil or a placebo nasal spray … [Read more...] about Pneumagen initiates Phase 2 challenge study of Neumifil nasal spray against flu
Positive Phase 3 results for Bharat Biotech’s BBV154 intranasal COVID-19 vaccine
According to Bharat Biotech, two recently completed Phase 3 trials of its BBV154 intranasal COVID-19 vaccine demonstrated the safety and tolerability of the recombinant replication-deficient adenovirus vectored vaccine and as well as its ability to elicit an immune response. One of the trials enrolled approximately 3100 subjects who received either two doses of BBV154 … [Read more...] about Positive Phase 3 results for Bharat Biotech’s BBV154 intranasal COVID-19 vaccine
Ceapro expands collaboration with McMaster University on development of inhaled yeast beta glucans
Canadian biotech Ceapro announced the expansion of an existing collaboration with McMaster University for development of inhaled yeast beta glucans for the prevention and treatment of lung fibrosis caused by COVID-19. According to Ceapro, the team has already successfully created inhalable yeast beta glucan particles via PGX and now plans to optimize delivery and … [Read more...] about Ceapro expands collaboration with McMaster University on development of inhaled yeast beta glucans
Aridis says that its AR-701 inhaled mAb cocktail is effective against SARS-CoV-2 in macaques
Aridis Pharmaceuticals said that its AR-701 inhaled monoclonal antibody cocktail effectively reduced viral load in rhesus macaques infected with SARS-CoV-2 and protected against lung disease in those animals over a 5-day period. The company received $1.9 million from the Bill & Melinda Gates Foundation in January 2022 for preclinical development of its inhaled … [Read more...] about Aridis says that its AR-701 inhaled mAb cocktail is effective against SARS-CoV-2 in macaques
Opiant gets addition $2.1 million from BARDA for OPNT003
Opiant Pharmaceuticals said that it has received an additional $2.1 million from the US Biomedical Advanced Research and Development Authority (BARDA) to support regulatory activities related to its OPNT003 intranasal nalmefene for the treatment of opioid overdose. BARDA had already provided an additional $2.2 million for OPNT003 earlier this year, and the total … [Read more...] about Opiant gets addition $2.1 million from BARDA for OPNT003
Verona announces that Phase 3 trial of nebulized ensifentrine for COPD met its primary endpoint
Verona Pharma said that the Phase 3 ENHANCE-2 trial of nebulized ensifentrine for treatment of COPD met its primary endpoint, with an average change from baseline in FEV1 AUC, 0-12 hours post dose, of 94 ml at week 12. In addition, a number of secondary endpoints were met, and for patients who got ensifentrine, the rate of exacerbations was reduced by 42% over 24 … [Read more...] about Verona announces that Phase 3 trial of nebulized ensifentrine for COPD met its primary endpoint
Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients
Renovion announced that the company has gotten the go-ahead from the FDA to initiate a Phase 3 clinical trial of its ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid for the prevention of bronchiolitis obliterans in bilateral lung transplant patients who have recently had a reduction in lung function. ARINA-1, which is delivered via the PARI eFlow nebulizer … [Read more...] about Renovion announces planned Phase 3 trial of ARINA-1 inhaled mucolytic in bilateral lung transplant patients
Krystal Biotech announces Phase 1 trial of KB407 inhaled gene therapy for cystic fibrosis
Krystal Biotech said that the FDA has cleared an IND submitted by the company at the beginning of July 2022 and that it now intends to initiate a Phase 1 trial of its KB407 nebulized re-dosable gene therapy for the treatment of cystic fibrosis sometime before the end of this year. The company had previously announced a Phase 1 study of KB407 taking place in Australia. … [Read more...] about Krystal Biotech announces Phase 1 trial of KB407 inhaled gene therapy for cystic fibrosis