Medical

Vistagen has announced the initiation of a Phase 2 repeat dose study of fasedienol nasal spray, which the company is developing for the treatment of social anxiety disorder. The Phase 3 PALISADE-3 and PALISADE-4 trials of fasendiol for that indication are ongoing. According to Vistagen, the design of the Phase 2 repeat dose trial is basically the same as the … [Read more...] about Vistagen initiates Phase 2 repeat dose study of fasendiol nasal spray

Orexo has announced topline results from its OX640-002 PK/PD study of OX640 intranasal dry powder epinephrine in people with allergic rhinitis. According to the company, the study, which was initiated in October 2024, demonstrated that absorption of OX640 occurred significantly faster in subjects with allergic rhinitis symptoms than in those without rhinitis symptoms. … [Read more...] about Orexo says study demonstrated that OX640 intranasal dry powder epinephrine is absorbed faster in subjects with allergic rhinitis

Aer Therapeutics has announced the initiation of the AER-01-002 Phase 2a proof-of-concept study of nebulized fexlamose (formerly AER-01) in COPD patients with high mucus plug scores. The trial is expected to enroll 100 patients with moderate-to-severe COPD who will receive daily fexlamose for 28 days. Aer said that it expects to have top-line data available in January … [Read more...] about Aer Therapeutics initiates Phase 2a trial of inhaled fexlamose (AER-01) in COPD patients

Qnovia (formerly Respira Technologies) has announced the initiation of a Phase 1 PK study of its QN-01 inhaled nicotine, which is delivered via the company's RespiRx vibrating mesh inhaler. In October 2024, Qnovia announced that the FDA had cleared an IND for the trial, which is expected to enroll 24 healthy adults who are current cigarette smokers. Results from … [Read more...] about Qnovia initiates Phase 1 trial of QN-01 RespiRx inhaled nicotine

Arcturus Therapeutics announced that it initiated 2 studies in December 2024, one of which is a Phase 2 MAD trial of ARCT-032 inhaled mRNA therapy in cystic fibrosis patients. The company announced in September 2024 that the FDA had cleared its IND for the study, which is expected to enroll 12 adults with CF who do not benefit from CFTR modulators and will evaluate 3 … [Read more...] about Arcturus announces the initiation of a Phase 2 trial of ARCT-032 inhaled mRNA therapy for cystic fibrosis. 

CyanVac has announced the initiation of a Phase 2b clinical study of CVXGA intranasal COVID-19 vaccine shortly after the company announced results from its Phase 2a trial. The Phase 2b trial, which is expected to enroll 10,000 participants, is funded by the Biomedical Advanced Research and Development Authority (BARDA) and will be conducted by the BARDA clinical … [Read more...] about CyanVac initiates Phase 2b trial of CVXGA intranasal COVID-19 vaccine

Tiziana Life Sciences announced that a Phase 2a clinical of intranasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS) has been expanded to include additional trial sites at Yale, Johns Hopkins, Cornell, Thomas Jefferson University, SUNY Buffalo, and UMass. The trial was initiated at the end of 2023 at Brigham and Women's … [Read more...] about Tiziana announces expansion of Phase 2 trial of intranasal foralumab for SPMS

Blue Lake Biotechnology and CyanVac reported that a Phase 2a clinical trial of their CVXGA intranasal vaccine against SARS-CoV-2 demonstrated that participants who received CVXGA had a 78% lower risk of symptomatic infection one month post vaccination compared to those who got a placebo. The study enrolled 227 participants. In addition, the companies said that no … [Read more...] about Blue Lake and CyanVac report data from Phase 2a trial of CVXGA intranasal COVID-19 vaccine