Aerovate Therapeutics says that the Phase 2b portion of the Phase 2b/3 IMPAHCT trial of the company's AV-101 inhaled dry powder imatinib in patients with pulmonary arterial hypertension (PAH) failed to meet its primary endpoint of change in pulmonary vascular resistance compared to placebo for any of the doses studied. The IMPAHCT trial was initiated in December … [Read more...] about Phase 2b trial of Aerovate’s AV-101 imatinib DPI in PAH patients fails to meet primary endpoint
Medical
BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
The Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS), announced that it has awarded approximately $40 million to CyanVac and approximately $34 million to CastleVax to support Phase 2b clinical trials of the companies' intranasal COVID-19 vaccine candidates. Each of the Phase 2b trials will … [Read more...] about BARDA awards ~$40 million to CyanVac and ~$34 million to CastleVax for Phase 2b trials of intranasal COVID-19 vaccines
Cessatech initiates Phase 3 pediatric trial of CT001 sufentanil / ketamine nasal spray for acute pain
According to Rigshospitalet spin-out Cessatech, the company has initiated a Phase 3 trial of its CT001 sufentanil / ketamine nasal spray in children seen in the emergency department with moderate to severe pain. In July 2022, Cessatech announced plans for the 0205 trial of CT001 in adult patients following extraction of wisdom teeth, and the company reported results … [Read more...] about Cessatech initiates Phase 3 pediatric trial of CT001 sufentanil / ketamine nasal spray for acute pain
Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI
Celon Pharma has disclosed a deal in which it will invest $20 million over 2 years, and Tang Capital will invest $10 million over that same period, in a new US-based company called Novohale Therapeutics that will initiate Phase 3 development of Celon's Falkieri esketamine DPI for the treatment of bipolar depression. Celon's marketed products include the Salmex … [Read more...] about Celon Pharma announces creation of Novohale Therapeutics in partnership with Tang Capital, Phase 3 development of Falkieri esketamine DPI
Cleveland Clinic to perform additional preclinical testing of dry powder universal flu vaccine candidates formulated with TFF technology
TFF Pharmaceuticals announced the Cleveland Clinic Florida will perform additional preclinical studies of 3 dry powder hemagglutinin antigen/adjuvent vaccine candidates produced under a 2023 SBIR grant to TFF for preclinical development of a dry powder pan-influenza vaccine formulation for inhaled and/or nasal delivery. The vaccine developed in Ted Ross's lab at the … [Read more...] about Cleveland Clinic to perform additional preclinical testing of dry powder universal flu vaccine candidates formulated with TFF technology
Inimmune announces results from Phase 1b trial of INI-2004 intranasal TLR4 agonist
According to Inimmune, a Phase 1b trial of its INI-2004 TLR4 agonist in people with allergic rhinitis demonstrated dose dependent reduction of nasal congestion compared to placebo in a ragweed challenge test, with a reduction of 53% for the highest dose. The company also said that all doses were well tolerated, with no difference in adverse events between the INI-2004 … [Read more...] about Inimmune announces results from Phase 1b trial of INI-2004 intranasal TLR4 agonist
EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
EVŌQ Bio said that it had positive feedback from the FDA following a pre-IND meeting about EVQ-218 inhaled non-ionic silver nanoparticle, which the company is developing for the treatment of pulmonary bacterial infections in cystic fibrosis patients with funding from the Cystic Fibrosis Foundation. According to parent company EVŌQ Nano's web site, an IND submission … [Read more...] about EVŌQ Bio says it had pre-IND meeting with the FDA for its EVQ-218 inhaled non-ionic silver nanoparticle
Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
DPI developers Iconovo have announced plans to develop inhaled GLP-1 receptor agonists for the treatment of obesity and, potentially, related metabolic diseases. The company says that it plans to conduct preclinical proof-of-concept studies itself and then will look to out-license the inhalers. As part of its efforts in this area, the company said that it had filed "a … [Read more...] about Iconovo announces plans for development of inhaled GLP-1 products for the treatment of obesity
Bespak and DevPro developing HFO-1234ze albuterol MDI
CDMO Bespak and DevPro Biopharma have revealed their partnership on development of DevPro's DP007 albuterol MDI, which is formulated with Honeywell's Solstice Air HFO-1234ze(E) propellant. According to the companies, DP007 is expected to provide a lower global warming potential alternative to Ventolin HFA MDI. Bespak and DevPro say that they plan to initiate clinical … [Read more...] about Bespak and DevPro developing HFO-1234ze albuterol MDI
Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned
Gossamer Bio and Chiesi Farmaceutici have partnered to develop and commercialize Gossamer's seralutinib inhalation powder for the treatment of pulmonary hypertension, the companies announced. Chiesi, which will get 50% of US commercial profit and ex-US rights to seralutinib, will pay Gossamer $160 million for development reimbursement; up to $146 million in regulatory … [Read more...] about Chiesi and Gossamer Bio partner on development of seralutinib DPI for pulmonary hypertension; Phase 3 trial planned