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Pulmatrix Presents PUR3100 Phase 1 Data at the 65th Annual Meeting of the American Headache Society
LEXINGTON, Mass., June 15, 2023 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled
About this update from Pulmatrix, Inc.
[{"type":"text","content":"LEXINGTON, Mass., June 15, 2023 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE™ technology, today announced it will present data at the American Headache Society 65th Annual Meeting, being held from June 15th through 18th both virtually and in-person at the J.W. Marriott in Austin, Texas.\n\n \n \n \n \n \n \n\n \nThe poster showcases data from the Phase 1 study of PUR3100, an orally inhaled dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine in 26 subjects, ages 18-49 years. \nInformation on the poster session is as follows:\nTitle: \"A Phase 1 Study to Assess Safety, Tolerability, and Pharmacokinetics of PUR3100, Novel Dry Powder Formulation of DHE for Oral Inhalation, in Healthy Adults\"Poster number: P-05Poster available for viewing: from Thursday, June 15th, 4:00 pm (Central Time)Attended poster session: Friday, June 16th, 12:35 – 1:50 pm (Central Time)\nView the poster here on the Pulmatrix website.\nThe Phase 1 trial was a randomized, double-dummy, double-blinded design to assesses the safety, tolerability, and pharmacokinetics (PK) of three dose groups of inhaled PUR3100 with intravenous (IV) placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo. PUR3100 was generally well tolerated with fewer TEAEs in PUR3100-treated groups than in the IV DHE-treated group.\nThe pharmacokinetic results showed a Tmax at the first time point (5 min) for all PUR3100 doses. All three doses achieved 'therapeutic' exposure levels (>1000 pg/mL). Cmax was within the desired exposure window, with similar Tmax and dose normalized AUC relative to IV DHE.\nDr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix, commented, \"Based on these data showing rapid systemic exposure in the therapeutic range and the improved side effect profile compared to IV dosing, we believe that PUR3100 has the potential to meet the significant unmet needs of the approximately 40 million patients in the U.S. with acute episodic migraine. Based on these Phase 1 results, we are eager to advance PUR3100 into Phase 2 testing and plan to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration...