OSM-0205 / Osmol Therap - LARVOL DELTA

FDA Notifies Osmol Therapeutics that the First-in-Human Phase 1 Clinical Trial of OSM-0205 for the Prevention of Chemotherapy-induced Peripheral Neuropathy (CIPN) May Proceed (Businesswire) - "Osmol Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) notified the company that the first-in-human clinical trial of OSM-0205 in healthy subjects for the prevention of CIPN may proceed. Osmol filed the Investigational New Drug application (IND) with the FDA for OSM-0205 in August 2023....'This first-in-human Phase 1 clinical trial in healthy subjects will determine the safety, tolerability, and pharmacokinetics of single ascending doses of OSM-0205 intravenous infusion to select a dose to evaluate in Phase 2 clinical studies in breast cancer patients.'"

IND • New P1 trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Osmol Therapeutics Provides Corporate Update at BIOTECH SHOWCASE 2023 (Businesswire) - "Osmol Therapeutics, today announced that it is presenting at BIOTECH SHOWCASE 2023, a leading investor conference focused on driving advances in therapeutic development taking place in San Francisco from January 9-11, 2023....There is an urgent need for a therapy to prevent CIPN and we expect to begin a Phase 1 clinical trial of OSM-0205 in the first half of 2023.'"

New P1 trial • CNS Disorders • Pain • Peripheral Neuropathic Pain

Osmol Therapeutics Announces Closing of Series A-1 Funding to Advance the Clinical Development of the First Therapy to Prevent Chemotherapy-Induced Neuropathy (Businesswire) - "Funding will support development of OSM-0205 through IND filing....Osmol Therapeutics...today announced that it has closed the first $5.2 million tranche of a $7.5 million Series A-1 financing led by Koax Investment Partners, a fund formed by the founders of Biohaven Pharmaceuticals....The remaining capital being raised for the Series A-1 will fund our Phase 1 bioavailability trial in the first half of 2023 and support the initiation of a Phase 2 proof-of-concept clinical study in mid-2023."

Financing • New P2 trial • CNS Disorders • Pain • Peripheral Neuropathic Pain