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
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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
Atossa to refocus development of AT-H201 on the treatment of radiation-induced lung injury
Atossa Therapeutics said that it has completed the first three parts of a Phase 1/2a trial, which was announced in July 2021, but it will skip the remaining part. Part D had been expected to enroll hospitalized COVID-19 patients; however, the company said that it will instead shift development of the inhaled heparin / n-acetylcysteine therapy to the treatment of … [Read more...] about Atossa to refocus development of AT-H201 on the treatment of radiation-induced lung injury
ACM Biolabs initiates Phase 1 trial of ACM-001 intranasal COVID-19 vaccine
ACM Biolabs has announced the initiation of a Phase 1 trial of its ACM-001 vaccine candidate against SARS-CoV-2. The SAD study will compare ACM-001 to an intramuscular vaccine as a booster in 80 healthy adults who have already received 3 doses of a COVID-19 vaccine. According to ACM, the intranasal vaccine is based on the company's artificial cell membrane (ACM) … [Read more...] about ACM Biolabs initiates Phase 1 trial of ACM-001 intranasal COVID-19 vaccine
InCarda Therapeutics initiates Phase 3 trial of InRhythm inhaled flecainide for atrial fibrillation
InCarda Therapeutics has announced the initiation of the Phase 3 RESTORE-1 trial of its InRhythm flecainide inhalation solution in patients with new or recurrent atrial fibrillation. According to InCarda, the FDA has agreed that the RESTORE-1 trial alone will be sufficient to support an NDA for the flecainide inhalation solution for use under medical supervision to … [Read more...] about InCarda Therapeutics initiates Phase 3 trial of InRhythm inhaled flecainide for atrial fibrillation
Phase 1b challenge study of Revelation’s REVTx-99b nasal spray fails to meet efficacy endpoints
Revelation Biosciences announced that the Phase 1b CLEAR challenge study of its REVTx-99b intranasal phosphorylated hexaacylated disaccharide (PHAD) in participants with allergies to rye grass pollen showed that the nasal drops were safe and well tolerated but failed to demonstrate any reduction of allergy symptoms or improvement in breathing. The company said that, … [Read more...] about Phase 1b challenge study of Revelation’s REVTx-99b nasal spray fails to meet efficacy endpoints
Phase 3 trial of VistaGen’s PH94B nasal spray for social anxiety disorder fails to meet primary endpoint
VistaGen Therapeutics said that the PALISADE-1 Phase 3 clinical trial of PH94B aloradine nasal spray for the treatment of anxiety in social anxiety disorder failed to meet its primary endpoint. The company announced the initiation of the PALISADE-1 trial in May 2021, and a second Phase 3 trial, PALISADE-2, got underway in September 2021. According to VistaGen, "the … [Read more...] about Phase 3 trial of VistaGen’s PH94B nasal spray for social anxiety disorder fails to meet primary endpoint
Phase 1 trial of Blue Lake’s BLB-201 intranasal vaccine for RSV gets underway
CyanVac subsidiary Blue Lake Biotechnology said that dosing has begun in a Phase 1 clinical trial of the company's BLB-201 intranasal vaccine against respiratory syncytial virus. The open label trial is expected to enroll 15 healthy adults aged 18 to 59 and 15 adults aged 60 to 75 who will each receive a single intranasal dose of BLB-201. The company had announced … [Read more...] about Phase 1 trial of Blue Lake’s BLB-201 intranasal vaccine for RSV gets underway
Impel initiates Phase 2a study of INP105 intranasal olanzapine in autistic adolescents
Impel Pharmaceuticals said that it has initiated a Phase 2a study of its INP105 intranasal olanzapine in adolescents with autism spectrum disorder, with results expected early next year. In January 2019, Impel (then Impel Neuropharma) announced positive Phase 1 results for INP105, which it was developing at the time for the treatment of acute agitation in bipolar I … [Read more...] about Impel initiates Phase 2a study of INP105 intranasal olanzapine in autistic adolescents