Press Releases

Lexington, MA, May 5, 2014 – Pulmatrix today announced the successful completion and positive results of the second part of a two-part Phase 1B clinical study in chronic obstructive pulmonary disease (COPD) patients with their lead clinical candidate, PUR0200.  PUR0200 is a bronchodilator therapy for COPD and is the first small molecule formulation from the company's novel iSPERSE™ inhaled dry powder technology.  The Phase 1B clinical trial compared the pharmacokinetic/pharmacodynamic profile of single doses of PUR0200 to an active comparator or placebo in patients with moderate to severe COPD.

The company is presenting data on the iSPERSE dry powder delivery platform at the 2014 Respiratory Drug Delivery (RDD) Conference on May 5 in Fajardo, Puerto Rico.  The poster presentation will highlight additional aspects of iSPERSE in the enablement of high drug load delivery in formulations with long term stability.

Robert Clarke, PhD, Chief Executive Officer of Pulmatrix added, “The PUR0200 clinical data mark a major step in the advancement of PUR0200 and highlight the exceptional lung delivery advantages iSPERSE offers over existing products.  These data significantly advance our PUR0200 development program and support our efforts to identify additional development candidates for the company.”

In the Phase 1B study, lung function and pharmacokinetics were assessed after administration of placebo, a lactose blend active comparator, or three doses of PUR0200 using a cross-over study design. The results demonstrate the effectiveness and efficiency in targeted lung delivery of the iSPERSE dry powder technology over traditional lactose blend formulations and the potential to enable delivery of new classes of compounds not feasible with lactose technologies:

• Because of iSPERSE’s delivery capabilities, nominal doses of PUR0200 were 50 to 80% lower than the nominal dose of the active comparator lactose blend formulation.
• All doses of PUR0200 resulted in statistically significant increases in lung function compared to placebo, as measured by peak and trough FEV1 increases from baseline.
• The lung function improvement following all PUR0200 doses was similar or numerically greater than the active comparator arm. 
• Plasma levels of PUR0200 increased dose proportionally and were comparable to the active comparator arm at the lowest nominal doses tested.
• This study identified doses of PUR0200 slated for additional clinical testing planned for the second half of 2014.

David Hava, PhD, Chief Scientific Officer of Pulmatrix, commented, “The completion of our Phase 1B clinical trial with PUR0200 significantly expands our understanding of the PUR0200 formulation and sets a clear path for future development.  The ability to match the pharmacodynamic and pharmacokinetic profile of the active comparator at significantly lower nominal doses highlights the potential of PUR0200 to bring meaningful benefit to patients. These data demonstrate the first clinical evidence of iSPERSE’s advantages over conventional lactose blend products.  We are encouraged by the continued performance of PUR0200 and the iSPERSE platform and look forward to further advancing this program in 2014.”

PUR0200 was designed using the Pulmatrix proprietary iSPERSE platform, an engineered particle technology that facilitates flow rate independent, high efficiency drug delivery to the lungs.

The Phase 1B study was conducted by Quotient Clinical in Nottingham, England, in conjunction with Professor Dave Singh at the Medicines Evaluation Unit in Manchester, England.  Thirty- eight moderate to severe COPD patients were enrolled and treated during this Phase IB study.

About COPD

Chronic obstructive pulmonary disease (COPD) is a major cause of death and disability throughout the world. The World Health Organization (WHO) figures estimated that 210 million people are living with COPD. According to WHO more than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. WHO predicts that COPD will become the third leading cause of death worldwide by 2030.

As COPD progresses, lung function declines and physical activity may become severely limited, adversely affecting the quality of patients’ lives. Early diagnosis and intervention with appropriate treatment following an exacerbation is important to help patients recover more rapidly and improve their quality of life.

About Pulmatrix

Pulmatrix, Inc. is a clinical stage biotechnology company developing and commercializing a novel inhaled dry powder drug platform to create a new generation of inhaled therapeutics. The platform, called iSPERSE™ (inhaled small particles easily respirable and emitted), enables drugs to be delivered in inhaled dry powders with unique properties for high drug loading and highly efficient dispersibility and delivery to the airways. iSPERSE can create dry powder formulations with virtually any drug substance, including small molecules, biologics and multi‐drug combinations.
 

The Company is pursuing both proprietary and partnered applications for iSPERSE.  For additional information about Pulmatrix, please visit www.pulmatrix.com.
 
iSPERSE™ is a trademark of Pulmatrix, Inc.
 
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The Yates Network
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