Mylan has agreed to co-develop the Pulmatrix clinical-stage drug candidate PUR0200, a once-daily treatment under study for chronic obstructive pulmonary disease (COPD), outside the U.S. The value of the partnership was not disclosed.
PUR0200 is a branded generic bronchodilator that is the first small molecule formulation from Pulmatrix’ iSPERSE™ inhaled dry powder delivery platform. Dispensed through a capsule-based dry powder inhaler (DPI), PUR0200 contains a long-acting muscarinic agent (LAMA).
Because nearly all of the dose reaches the site of action in the lung and is not swallowed or otherwise lost, PUR0200 can achieve the same effect as the unspecified reference product at 20% of the dose administered, according to Pulmatrix. The reference product is a bronchodilator that uses iSPERSE.
Current clinical development of PUR0200 is focused on pharmacokinetic (PK) bioequivalence in Europe, Pulmatrix and Mylan said.
A European PK bioequivalence clinical study to advance development of PUR0200 is to be launched during the second half of this year, Pulmatrix also said today, with a PK profile of PUR0200 versus the reference product from the clinical study set to be reported during the first half of 2016.
A U.S. development program is being planned, Pulmatrix stated on its website.
Under their agreement, Pulmatrix will lead the development work and pharmacokinetic clinical study with Mylan offering collaborative support. Mylan has retained an option for PUR0200 outside the U.S. based on successful completion of the clinical study.
“This collaboration demonstrates our continued commitment to building our global respiratory pipeline, a key strategic growth driver for the company,” Mylan President Rajiv Malik said in a headline.
Added Pulmatrix CEO Robert W. Clarke, Ph.D.: “At the current stage of development of PUR0200 and goals of the program, Mylan is the ideal partner to bring this product forward for COPD patients.”
The partnership was one of several announcements today by Pulmatrix, which also said it raised $10 million through a private placement; disclosed the lead candidate in its pipeline focused on rare pulmonary diseases; and completed its previously-announced merger with Ruthigen as of Monday—with the company renaming taking the Pulmatrix name and set to start trading shares today on NASDAQ.
“Following the financing and merger, we have $27 million in cash, which we expect will fund our business into 2017, beyond multiple data readouts from ongoing and planned clinical studies, as well as other corporate milestones,” Dr. Clarke said.
Participants in the private placement included pre-merger investors in Pulmatrix such as funds affiliated with 5AM Ventures, ARCH Venture Partners and Polaris Partners, as well as funds affiliated with Altitude Life Science Ventures.
Pulmatrix also revealed lead candidate PUR1900, a preclinical compound that the company said was the first inhaled anti-infective to treat fungal infections associated with cystic fibrosis (CF).
PUR1900 is an iSPERSE formulation incorporating an anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects. According to the company, nearly 50% of CF patients experience pulmonary fungal infections that can cause chronic bronchitis or allergic reactions, resulting in inflammation and poor long term outcomes.
Rounding out Pulmatrix’ announced pipeline is PUR1500, an iSPERSE formulation incorporating a kinase inhibitor with established anti-angiogenesis activity for idiopathic pulmonary fibrosis (IPF). That compound is in its formulation feasibility phase, Pulmatrix said.