Pulmatrix Inc【PULM】株式ニュース

Pulmatrix Announces FDA Acceptance of IND Application for PUR3100 to Treat Acute Migraine
https://finance.yahoo.com/news/pulmatrix-announces-fda-acceptance-ind-130500671.html

Pulmatrix received a study may proceed letter for a Phase 2 Study to Evaluate PUR3100, an orally inhaled dry powder formulation of dihydroergotamine ("DHE") in the treatment of acute migraine
BEDFORD, Mass., Sept. 19, 2023 /PRNewswire/ -- Pulmatrix, Inc. ("Pulmatrix" or the "Company") (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system diseases, today announced the U.S. Food and Drug Administration ("FDA") has accepted the PUR3100 investigational new drug ("IND") application and the Company has received a study may proceed letter for a Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Event Study to Evaluate the Safety, Tolerability, and Efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) in the Acute Treatment of Migraine. The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE via oral inhalation using a dry powder inhaler.

Dr. Margaret Wasilewski, Chief Medical Officer of Pulmatrix noted, "We are pleased with the PUR3100 IND acceptance and receipt of the study may proceed letter for the Phase 2, proof of concept study. We are looking forward to building on the positive safety and pharmacokinetic data established in our phase 1 study."
Ted Raad, Chief Executive Officer of Pulmatrix, commented, "We believe that PUR3100 has the potential to be differentiated from other approved acute migraine therapies currently available on the market, given the convenience of self-administration and the potential for rapid pain relief and improved DHE tolerability. The completed Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability of PUR3100 compared to IV DHE. We are currently pursuing options to advance PUR3100 into a Phase 2 clinical trial to investigate PUR3100 efficacy, safety, tolerability in treating acute migraine subjects."

About PUR3100
PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine. The Phase 1 PUR3100 trial results were presented at the 65th Annual Meeting of the American Headache society in June 2023. Over 38 million patients suffer from migraine in the United States and there is currently no orally inhaled DHE treatment option for patients.

About iSPERSE™ Technology
Our innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE is a proprietary technology that allows a broad range of drugs to be formulated as small, dense, and dispersible particles for highly efficient drug delivery and deep penetration into the lungs. iSPERSE can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.
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.

Pulmatrix is a company that develops innovative inhaled therapies for various diseases using its patented iSPERSE™ technology.

iSPERSE™ stands for intelligent Spray-dried Powders with Engineered Respiratory Syncytial Virus (RSV) Properties, and it is a platform that allows the delivery of small or large molecules to the lungs in a dry powder form.

Pulmatrix claims that iSPERSE™ has several advantages over conventional inhalation technologies, such as higher efficiency, lower dose, better safety, and broader applicability.

Pulmatrix has two products in clinical development:

PUR3100 and PUR1800.

PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE), a drug that is used to treat acute migraine.

Pulmatrix has completed a Phase 1 study of PUR3100 and plans to start a Phase 2 study in mid-2023.

PUR1800 is an orally inhaled formulation of itraconazole, an antifungal drug that is used to treat allergic bronchopulmonary aspergillosis (ABPA), a rare lung disease.

Pulmatrix has initiated a Phase 2b study of PUR1800 and expects to report results in mid-2024.

Pulmatrix is also exploring other applications of its iSPERSE™ technology, such as delivering drugs for central nervous system disorders, infectious diseases, and cancer.

Pulmatrix has partnered with several academic and industry collaborators to advance its research and development.

Pulmatrix announced the submission of an IND application to the FDA for PUR3100 in July 2023 and received a study may proceed letter for a Phase 2 trial in September 2023.

The Phase 2 trial is a multicenter, randomized, double-blind, placebo-controlled, single event study to evaluate the safety, tolerability, and efficacy of PUR3100 in patients with acute migraine.

PUR1800 is an orally inhaled dry powder formulation of itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA), a rare inflammatory lung disease.

August 18th 8-K
Revenues increased $0.5 million to $1.8 million for the three months ended June 30, 2023 compared to $1.3 million for the three months ended June 30, 2022. The increase is related to the Company’s revenues recognized in accordance with the Cipla Agreement for PUR1900 during the period.
Pulmatrix’s total cash and cash equivalents balance as of June 30, 2023 was $25.8 million. The Company anticipates that its cash position, based on operational efficiencies and prioritization of spending, is sufficient to fund its operations into the first quarter of 2025.
https://ih.advfn.com/stock-market/NASDAQ/pulmatrix-PULM/stock-news/91783950/form-8-k-current-report