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PULM: MHRA Authorizes CTA; Patient Screening Commences!

By Anita Dushyanth, PhD


Pulmatrix (NASDAQ:PULM) management filed a Clinical Trial Application (CTA) in 2H 2017 in the EU to support a Phase 1/1b trial in healthy volunteers and asthmatics, which is anticipated to commence in 1H 2018.  The goal of the trial is to establish the safety and tolerability of PUR1900, an inhaled dry-powder formulation of itraconazole.  The study will recruit healthy volunteers and a target patient population to gain a better understanding of the single and repeat dose pharmacology of itraconazole when delivered to the lung.  Earlier this week the firm announced that they received authorization of the CTA from U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) to initiate the first clinical trial for PUR1900 – which we view as a major milestone for Pulmatrix.  

Phase 1/1b is a critical milestone establishing PUR1900 safety, tolerability and PK profile versus ABPA-Asthma oral antifungal standard of care (Sporanox).  The clinical plan for Phase 1/1b PUR1900 is a three-part study comprised of single ascending dose (SAD), multiple ascending dose (MAD) as well as single dose comparing inhaled versus oral dose of the drug.  The studies will be conducted in parallel.

The SAD study will recruit healthy volunteers who will be administered escalating doses of PUR1900 (dose: 5mg, 10mg and 25mg) to assess safety and tolerability along with 96h PK profile.  The MAD trial will also recruit healthy volunteers to study the PK profile as well as safety and tolerability over a 14-day dosing period (10mg and 20mg).  Part 3 of the Phase 1/1b trial is a crossover study designed to determine the PK, safety and tolerability of single dose of 20mg of PUR1900 (inhaled route) as compared to 200mg of Sporanox (oral route) in patients with mild to moderate stable asthma.  The study is designed to include up to 42 volunteers in the SAD/MAD evaluation and 16 asthmatic patients in the crossover study. 
The firm is now actively screening subjects and anticipates dosing to commence in early February.  Pulmatrix anticipates data read-out in mid-2018 and plans to use the Phase 1/1b data to support initiation of a Phase 2 program in patients with ABPA, which is expected to initiate in 2H 2018. 


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