Pulmatrix Announces Peer-Reviewed Publication of Clinical Results for its Orally Inhaled DHE for Acute Migraine (PUR3100)
Pulmatrix announced the publication of clinical results for its orally inhaled DHE (PUR3100) for acute migraine in the peer-reviewed journal Headache: The Journal of Head and Face Pain. The Phase 1 study showed that PUR3100 has rapid systemic pharmacokinetics (PK) similar to intravenous (IV) DHE, with a mean time to maximum concentration (Tmax) of 5 minutes and a mean concentration (Cmax) in the therapeutic window for all doses tested.
Compared to IV DHE, PUR3100 demonstrated improved safety and tolerability, with lower incidences of nausea, vomiting, and headache. Pulmatrix received FDA acceptance for an Investigational New Drug (IND) application for a Phase 2 study, and the company is exploring options to advance PUR3100 into Phase 2 trials.
- Publication in a peer-reviewed journal enhances credibility.
- PUR3100 demonstrated rapid systemic PK with a Tmax of 5 minutes.
- Improved safety and tolerability compared to IV DHE.
- Lower incidences of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%).
- FDA acceptance of IND application for Phase 2 study.
- Potential to address unmet needs for acute migraine sufferers.
- Reduced AUC0–2h (1120–4320 vs. 6340) indicates less exposure over time compared to IV DHE.
- Lower Cmax (3620–14,400 vs. 45,000) compared to IV DHE may be less effective for some patients.
- Pulmatrix needs to secure financing or a partnership to proceed to Phase 2 clinical trials, indicating financial dependency.
Insights
The publication of clinical trial results for Pulmatrix's PUR3100 offers valuable insights into its potential efficacy and safety for treating acute migraines. The data shows that PUR3100, an orally inhaled version of dihydroergotamine (DHE), achieves rapid systemic pharmacokinetics comparable to the intravenous form, which indicates its potential for quick relief. This is significant because it provides a non-invasive option for migraine sufferers, reducing the need for hospital visits and intravenous administration.
Furthermore, the reported safety and tolerability improvements with PUR3100 are noteworthy. Lower incidences of nausea, vomiting and headaches compared to IV DHE could translate into better patient compliance and overall experience. The successful completion of Phase 1 and the FDA's acceptance of the IND application position the drug favorably for further clinical trials.
For stakeholders, this marks a promising advancement in migraine treatment, tapping into a market with significant unmet needs. The next steps would involve securing financing or partnerships to move into Phase 2 trials, which will be pivotal in validating these initial findings and potentially bringing the product closer to commercialization.
From a financial perspective, Pulmatrix's progress with PUR3100 could have substantial implications for the company's valuation and investor sentiment. The successful Phase 1 data and the readiness for Phase 2 trials reduce some of the risks associated with early-stage biopharma investments. If Phase 2 trials confirm the initial results, it could open up significant revenue streams in the migraine treatment market, which is substantial and growing.
However, it's essential to consider the financial risks associated with clinical trials. Securing financing or a partnership is crucial. Failure to do so could delay the product's development, impacting the company's financial health and stock price. Investors should also be aware of the competitive landscape and regulatory hurdles that could affect market entry and adoption.
In the short term, this announcement is likely to boost investor confidence and potentially lead to a positive stock price reaction. Long-term success will depend on continued positive trial results and strategic partnerships or financing to support the drug's development and commercialization.
Orally Inhaled PUR3100 is associated with rapid systemic PK within the therapeutic window and a mean time to Cmax matching intravenously (IV) administered DHE.
Self-administered PUR3100 showed improved safety and tolerability relative to IV DHE.
Pulmatrix previously received FDA's acceptance of an IND application and a "study may proceed" letter for a Phase 2 study, positioning PUR3100 as Phase 2-ready.
Ted Raad, Chief Executive Officer of Pulmatrix, commented, "In this trial, PUR3100 demonstrated the potential for rapid pain relief and improved DHE tolerability versus IV DHE. With a Tmax of 5 minutes and a Cmax in the therapeutic window for all doses tested, we believe that PUR3100 has the potential to address an unmet need for acute migraine sufferers and we are pursuing different options to advance PUR3100 into a Phase 2 clinical trial to further investigate its promising profile in treating acute migraine."
The completed Phase 1 study demonstrated optimal pharmacokinetics and improved tolerability of PUR3100 compared to IV DHE. The Phase 1 trial was a randomized, double-dummy, double-blinded design to assesses the safety, tolerability, and pharmacokinetics (PK) of three dose groups treated with inhaled PUR3100 with intravenous (IV) placebo, compared to a single dose of IV DHE (DHE mesylate injection) with inhaled placebo in healthy volunteers. All doses of PUR3100 were generally well tolerated with a lower incidence of nausea (
Please use this link to the early view on the journal, Headache: https://doi.org/10.1111/head.14731
Pulmatrix is currently looking at opportunities to finance or partner PUR 3100 to initiate a potential Phase 2 clinical study.
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
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 Headache
Headache: The Journal of Head and Face Pain is a peer-reviewed medical journal covering all aspects of head and face pain. It is the official journal of the American Headache Society. It was established in 1961 and is published ten times per year.
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system ("CNS"), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ technology. The Company's proprietary product pipeline includes treatments for CNS disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease ("COPD") and allergic bronchopulmonary aspergillosis ("ABPA"). 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 the Company's 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, the Company's ability to conduct its business and raise capital in the future when needed; 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.
FAQ
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