Medical

Ampio Pharmaceuticals has announced the initiation of the AP-019 Phase 2 clinical trial of inhaled Ampion for the treatment of respiratory distress in patients with COVID-19. The company said that it has also received the okay from the FDA to add at least one trial site in India which currently has a high incidence of COVID-19; the initial location was in the US. … [Read more...] about Ampio initiates Phase 2 trial of inhaled Ampion in COVID-19 patients

Aerami Therapeutics said that it has initiated dosing in a Phase 1 clinical trial of its AER-901 inhaled imatinib for the treatment of pulmonary arterial hypertension (PAH). According to the study description on clinicaltrials.gov, the SAD/MAD trial is expected to enroll 78 healthy volunteers and is expected to evaluate doses of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg in … [Read more...] about Aerami initiates Phase 1 trial of AER-901 inhaled imatinib for PAH

Nasus Pharma said that a Phase 1 PK study of its FMXIN002 intranasal dry powder epinephrine demonstrated that FMXIN002 could produce a maximum plasma level comparable to that of epinephrine delivered via EpiPen and reached that level significantly faster than the injection. The open-label SAD study enrolled 12 volunteers and compared 1.6 and 3.2 mg doses of FMXIN002 … [Read more...] about Positive results from Phase 1 trial of Nasus Pharma’s intranasal dry powder epinephrine

Theravance Biopharma said that a Phase 2 study of its inhaled nezulcitinib (TD-0903) pan-JAK inhibitor in hospitalized COVID-19 patients failed to meet its primary endpoint of respiratory failure free days at Day 28. The study did demonstrate some improvement in all-cause mortality, and in patients with C-reactive protein levels below 150 mg/L, nezulcitinib … [Read more...] about Phase 2 study of Theravance’s nezulcitinib inhaled pan-JAK inhibitor for COVID-19 fails to meet primary endpoint

Oyster Point Pharma has announced the initiation of the OLYMPIA Phase 2 clinical trial of its OC-01 varenicline nasal spray for the treatment of neurotrophic keratopathy. The company's NDA for OC-01 for the treatment of dry eye disease is currently under review by the FDA. The OLYMPIA study is expected to enroll approximately 100 patients with Stage 1 neurotrophic … [Read more...] about Oyster Point initiates Phase 2 trial of OC-01 varenicline nasal spray for neurotrophic keratopathy

Noveome Biotherapeutics said that a Phase 1 safety study of its intranasal ST266 secretome in glaucoma suspect patients demonstrated no serious adverse events at doses up to 400 µL per day over 28 days. The open label study evaluated single doses of 200 µL daily for 14 days, two doses of 200 µL daily for 14 days, and two doses of 200 µL daily for 28 days. Noveome … [Read more...] about Noveome announces Phase 1 results from study of intranasal ST266 in patients at risk of glaucoma