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Pulmatrix Seeks Divestment Of Clinical Assets And iSPERSE Inhalation Technology Amid Advancements In Migraine, COPD, And Antifungal Treatments

Benzinga Newsdesk 1 year ago

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Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ TechnologyiSPERSE™ TechnologyiSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed

Pulmatrix Currently Seeking Divestment of Clinical Assets and Proprietary iSPERSE™ Technology

iSPERSE™ Technology

  • iSPERSE™ particles are engineered with a small, dense and dispersible profile to exceed the performance of traditional dry powder particles as the iSPERSE™ particles have the dispersibility advantages of porous engineered particles. Pulmatrix believes this results in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases.
  • As of June 30, 2025, Pulmatrix's patent portfolio related to iSPERSE™ included approximately 146 granted patents, 18 of which are granted U.S. patents, and approximately 54 additional pending patent applications in the U.S. and other jurisdictions.

PUR3100

  • PUR3100 is an orally inhaled dihydroergotamine ("DHE") engineered with Pulmatrix's iSPERSE™ dry powder inhalation technology for the treatment of acute migraine.
  • In 2023, Pulmatrix announced the Food and Drug Administration's acceptance of an Investigational New Drug ("IND") application for PUR3100 and receipt of a "study may proceed" letter to proceed with a Phase 2 study, positioning PUR3100 as a Phase 2-ready asset. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine.
  • The Phase 2 IND builds on the Phase 1 trial results of PUR3100, which were published in 2024 in a peer-reviewed publication, Headache: The Journal of Head and Face Pain.
  • The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting compared to observations of nausea and vomiting in the intravenously ("IV") administered DHE dose group.

PUR1800

  • PUR1800 is a Narrow Spectrum Kinase Inhibitor ("NSKI"), engineered with our iSPERSE™ technology, for the treatment of acute exacerbations in chronic obstructive pulmonary disease ("AECOPD"). In 2023, Pulmatrix presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating PUR1800 was safe and well tolerated with no observed safety signals. The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases.

PUR1900

  • PUR1900 is the Company's inhaled iSPERSE™ formulation of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need.
  • The Company completed all Phase 2b wind down activities in the third quarter of 2024. With the study wind down complete, Pulmatrix bears no further financial responsibility for the development of PUR1900.
  • The Company's partner Cipla has continued clinical development outside the United States and has advised us that they have completed their Phase 2 study in India and have been approved by India's Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial.
  • Should Cipla successfully market PUR1900 outside the United States, Pulmatrix will receive 2% royalties on any potential future net sales by Cipla outside the United States. Within the United States, the Company and Cipla will seek to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need.

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