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.
The 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.
Information on the poster session is as follows:
Title: "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-05
Poster 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)
View the poster here on the Pulmatrix website.
The 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.
The 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.
Dr. 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 in mid-2023. The Phase 2 study would assess the safety and effectiveness of two dose levels of PUR3100. Pulmatrix is exploring partnership opportunities as a potential path forward for the Ph2 study."
About the American Headache Society ("AHS") and the 65th Annual Scientific Meeting
AHS has dedicated over 60 years to leading and serving the headache community. The American Headache Society Annual Scientific Meeting is designed for physicians, psychologists, scientists, researchers, physician assistants, nurse practitioners, and other health professionals involved in the care of patients with head, neck, and orofacial pain.
The American Headache Society's Annual Scientific Meeting continues to be the premiere venue for the dissemination of the latest and most up-to-date research and scientific advances underlying the practice of Headache Medicine.
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases and central nervous system ("CNS") disorders using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for lung diseases, such as allergic bronchopulmonary aspergillosis ("ABPA"), Chronic Obstructive Pulmonary Disease ("COPD") and CNS disorders such as acute migraine. Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
For more on our inhaled product candidates please visit: https://www.pulmatrix.com/pipeline.html.
Forward-Looking Statements
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are based on the beliefs of management as well as assumptions made by, and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company's ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; the ability to secure and enforce legal rights related to the Company's products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Investor Contact:
Timothy McCarthy, CFA
917-679-9282
tim@lifesciadvisors.com
SOURCE Pulmatrix, Inc.
