dihydroergotamine (PUR3100) / Pulmatrix - LARVOL DELTA

Pulmatrix Announces Peer-Reviewed Publication of Clinical Results for its Orally Inhaled DHE for Acute Migraine (PUR3100) (PRNewswire) - P1 | N=26 | NCT05351086 | Sponsor: Pulmatrix Inc. | "Pulmatrix, Inc...announced publication...in the peer-reviewed publication Headache: The Journal of Head and Face Pain....All doses of PUR3100 were generally well tolerated with a lower incidence of nausea (21% vs. 86%), vomiting (0% vs. 29%), and headache (16% vs. 57%) compared to IV DHE. The PK profile of PUR3100 versus IV DHE was characterized by a similar mean time to Cmax (5 vs. 5.5 min), with reduced AUC0–2h (1120–4320 vs. 6340), and a lower Cmax (3620–14,400 vs. 45,000). All doses of PUR3100 were associated with mean Cmax above the minimum level required to achieve efficacy (1000 pg/mL)."

P1 data • CNS Disorders • Migraine • Pain

Safety, tolerability, and pharmacokinetics of a single orally inhaled dose of PUR3100, a dry powder formulation of dihydroergotamine versus intravenous dihydroergotamine: A Phase 1 randomized, double-blind study in healthy adults. (PubMed, Headache) - "Inhaled PUR3100 is associated with rapid systemic PK within the therapeutic window and an improved safety profile relative to intravenous DHE."

Clinical • Journal • P1 data • PK/PD data • CNS Disorders • Migraine • Pain

Pulmatrix Announces FDA Acceptance of IND Application for PUR3100 to Treat Acute Migraine (PRNewswire) - "Pulmatrix, Inc...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."

IND • New P2 trial • CNS Disorders • Migraine • Pain

Pulmatrix Announces Second Quarter 2023 Financial Results and Provides Corporate Update (PRNewswire) - "PUR1900; PUR1900 is currently in a Phase 2 trial for the treatment of ABPA in patients with asthma....Pulmatrix anticipates topline data from this study in the third quarter of 2024....Research and development expenses decreased approximately $0.2 million to $4.2 million for the three months ended June 30, 2023 compared to $4.3 million for the three months ended June 30, 2022. The decrease was primarily due to decreased spend of $0.8 million in costs related to the Company's PUR3100 program and $0.1 million in costs related to the Company's PUR1800 program, partially offset by increases in spending of $0.5 million in costs related to the Company's PUR1900 program and $0.2 million of employment and operating costs."

Commercial • Allergic Bronchopulmonary Aspergillosis • Asthma • CNS Disorders • Infectious Disease • Migraine • Pain • Pulmonary Disease • Respiratory Diseases

Pulmatrix Announces Submission of IND Application to FDA to Initiate a Phase 2 Trial of Investigational Drug PUR3100 to Treat Acute Migraine (PRNewswire) - "Pulmatrix, Inc...announced the submission of an investigational new drug ('IND') application to the United States Food and Drug Administration ('FDA') for PUR3100, an orally inhaled dry powder formulation of dihydroergotamine ('DHE'), under development to treat acute migraine. The PUR3100 formulation uses Pulmatrix's novel, proprietary dry powder delivery technology, iSPERSE™ to deliver DHE directly into the lungs using a dry-powder inhaler. Pulmatrix's IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be investigated in patients with acute migraine."

IND • CNS Disorders • Migraine

A Phase 1 Study to Assess Safety, Tolerability, and Pharmacokinetics of PUR3100, a Novel Dry Powder Formulation of Dihydroergotamine for Oral Inhalation, in Healthy Adults. (AHS 2023) - "Overall, inhaled PUR3100 was safe and well tolerated, achieved a rapid Tmax at < 5 minutes. The Cmax and AUC of PUR3100 was linear and generally dose-proportional. The systemic exposure for all doses of PUR3100 resulted in a lower Cmax than IV DHE and in fewer treatment related TEAEs."

Clinical • P1 data • PK/PD data • CNS Disorders • Migraine • Pain

Pulmatrix Presents PUR3100 Phase 1 Data at the 65th Annual Meeting of the American Headache Society (PRNewswire) - P1 | N=26 | NCT05351086 | Sponsor: Pulmatrix Inc | "Pulmatrix, Inc...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. 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...' 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'."

IND • P1 data • CNS Disorders • Migraine • Pain

Pulmatrix to Host Key Opinion Leader Webinar “PUR3100 for the Treatment of Acute Migraine: Unlocking the Potential of DHE Treatment“ (PRNewswire) - “Pulmatrix, Inc…announced it will host a virtual key opinion leader (KOL) event…featuring Stewart J. Tepper, MD, from the Geisel School of Medicine at Dartmouth College. Dr. Tepper will discuss the current treatment landscape for migraine patients along with the mechanism of action and clinical profile of dihydroergotamine (DHE). Dr. Margaret Wasilewski MD, Chief Medical Officer at Pulmatrix, will follow with an update on the recently completed Phase 1 data with PUR3100, the company's orally inhaled DHE, delivered using Pulmatrix's iSPERSE™ technology, along with future clinical plans. The webinar will take place on Friday, February 3, 2023 at 10:00 AM ET.”

Clinical • P1 data • CNS Disorders • Migraine • Pain

Pulmatrix Announces Positive Top Line Results from a Phase 1 Study with PUR3100, a Novel Orally Inhaled Dihydroergotamine (DHE), for Acute Migraine (PRNewswire) - P1 | N=26 | NCT05351086 | Sponsor: Pulmatrix Inc. | "Pulmatrix...today announced successful completion of a Phase 1 trial evaluating safety and pharmacokinetics of PUR3100 in healthy volunteers. PUR3100 uses the Company's iSPERSE™ formulation technology to create an orally inhaled dry powder formulation of dihydroergotamine (DHE) for the treatment of acute migraine....PUR3100 was well-tolerated and there was a lower incidence of nausea in PUR3100 dose groups compared to IV DHE....Pulmatrix plans to present the data at an appropriate upcoming scientific conference. Dose selection is underway for the Phase 2 study and an FDA meeting will be requested this month....'We are excited to see how this pharmacokinetic differentiation potentially translates into clinical efficacy in the Ph2 proof-of-concept study that we intend to review with the FDA in the first half of 2023.'"

FDA event • P1 data • Trial completion • CNS Disorders • Migraine • Pain

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults (clinicaltrials.gov) - P1 | N=26 | Completed | Sponsor: Pulmatrix Inc. | Recruiting ➔ Completed

Trial completion

Pulmatrix Announces Third Quarter 2022 Financial Results and Provides Corporate Update (Pulmatrix Press Release) - "Phase 1 study database lock to occur in November with top-line data anticipated to be released in early Q1 2023."

P1 data • CNS Disorders • Migraine

Pulmatrix Announces Patient Dosing Completed for its Novel Inhaled Therapy PUR3100 for Acute Migraine (PRNewswire) - "Pulmatrix, Inc...announced that all subjects have completed dosing in a Phase 1 trial evaluating PUR3100, a novel orally inhaled formulation of dihydroergotamine (DHE) in healthy volunteers. Phase 1 data from this study is expected in Q4 2022."

Trial status • CNS Disorders • Migraine

Pulmatrix Announces Second Quarter 2022 Financial Results and Provides Corporate Update (PRNewswire) - "Pulmatrix, Inc...announced second quarter financial results for 2022 and provided a corporate update related to its development programs....PUR3100: On July 12, 2022, Pulmatrix announced the dosing of the first five subjects in a Phase 1 trial. To date, the trial has enrolled 23 of 24 patients and top-line data is anticipated in Q4 2022."

Enrollment status • P1 data • CNS Disorders • Migraine • Pain

Pulmatrix Announces First Subject Dosed in Phase 1 Study of PUR3100 for Acute Migraine (PRNewswire) - "Pulmatrix, Inc...announced the dosing of the first five subjects in a Phase 1 trial evaluating PUR3100, a novel pulmonary inhaled formulation of dihydroergotamine (DHE). PUR3100 is formulated using Pulmatrix's iSPERSE drug delivery technology and is being developed for the treatment of acute migraine. The Phase 1 study design is a double-dummy, double-blinded trial to assess the safety, tolerability, and pharmacokinetics of 3 doses of single doses of inhaled PUR3100 with IV placebo, as compared to IV DHE (DHE mesylate injection) with inhaled placebo. Twenty-four healthy volunteers are to be randomized to one of the four dose groups consisting of six subjects each."

Trial status • CNS Disorders • Migraine • Pain

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Pulmatrix Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Pulmatrix Inc.

New P1 trial

Pulmatrix Announces Year-End and Q4 Financial 2021 Results and Provides Corporate Update (PRNewswire) - "The Phase 1 study is intended to assess not only safety, tolerability, and pharmacokinetics of PUR3100 in humans, but also provide preliminary comparative bioavailability data to support the use of the 505(b)(2) pathway for marketing authorization. The Company anticipates initiating patient dosing for the Phase 1 study in Australia in Q3 2022, with top-line data anticipated in Q4 2022. A Phase 2 study to determine efficacy will be conducted in migraine patients evaluating two doses that were selected based on the Phase 1 study results. This study is projected to commence dosing in Q2 2023 with data by year-end 2023."

New P1 trial • New P2 trial • P1 data • P2 data • CNS Disorders • Migraine • Pain

Pulmatrix Reports Second Quarter 2021 Financial Results and Provides Business Update (PRNewswire) - 'PUR3100: 14-day toxicology results for PUR3100, Pulmatrix's dry powder iSPERSE formulation of dihydroergotamine (DHE) for pulmonary delivery to treat acute migraine are expected in Q3 2021. IND filing planned in Q4 2021, with a Phase 1/ Phase 2 clinical study start date anticipated in Q1 2022. Data from this proof-of-concept study are expected in Q4 2022."

Clinical data • IND • New P1/2 trial • P1/2 data • CNS Disorders • Migraine • Pain

Pulmatrix Hosting Key Opinion Webinar on PUR3100 (Orally Inhaled DHE) Therapy for the Treatment of Acute Migraine (PRNewswire) - "Pulmatrix...today announced that it will host a key opinion leader (KOL) webinar on PUR3100, Pulmatrix's orally inhaled dihydroergotamine (DHE) therapy for the treatment of acute migraine, on Friday, April 23, 2021 at 10:00am Eastern Time...PUR3100 is currently in pre-clinical investigation as an orally inhaled migraine therapy with Phase 1 and Phase 2 data anticipated in 2022."

P1 data • P2 data • Preclinical • CNS Disorders • Migraine

Pulmatrix Provides a Pipeline and Business Update (PRNewswire) - "PUR3100 plans to advance into IND enabling toxicology studies with anticipated Ph1/Ph2 clinical study start in Q1 2022...Completed a registered direct offering with gross proceeds of $40 million extending the Company's cash runway to fully fund data readouts across its development pipeline including...PUR3100 Phase 1 / Phase 2..."

Financing • IND • New P1/2 trial • CNS Disorders • Migraine • Pain