Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that it has received an award from Cystic Fibrosis Foundation Therapeutics(CFFT), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, to support the development of its lead inhaled anti-fungal product candidate PUR1900 for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with cystic fibrosis and asthma.
"This award will help fund the non-clinical safety studies needed for the Phase 1/1B clinical trial that we plan to begin in 2018," explained Pulmatrix CEO Dr. Robert Clarke. "It underscores the potential for PUR1900 to treat this serious condition, which is currently a major unmet medical need."
ABPA is caused by the spore-forming mold Aspergillus fumigatus. People breathe in Aspergillusspores all the time. Usually, the spores get stuck in the moist linings of the airways and are expelled in mucus, or are tackled and neutralized by the immune system. But in cystic fibrosis patients or others with compromised lung function or immune systems, the mold can lead to serious infections—and allergic reactions that manifest as ABPA.
Fighting these lung infections and the allergic reactions has been difficult. Oral anti-fungal drugs exist, but getting enough drug through the bloodstream to the lungs requires high doses that cause severe side effects—and still have low efficacy.
Pulmatrix has addressed this problem by combining an anti-fungal drug, itraconazole, with the company's innovative and proprietary iSPERSETM dry powder. The powder is designed to "fly" easily into the lungs when inhaled, delivering the high amounts of the drug directly to the lungs where it is needed.
The inhaled drug delivery approach is expected to reduce the risk of serious side effects and drug-drug interactions, while increasing the levels of the drug in the lung compared to oral dosing. In fact, preclinical trials with PUR1900 show that it achieves much higher concentrations of the drug in the lung, and much lower levels in the blood, compared to giving the drug orally.
The new award from CFFT will help fund on-going non-clinical safety studies of PUR1900. The company plans to follow those studies with a Phase 1/1B clinical study in healthy volunteers and asthmatic patients to compare PUR1900 with oral itraconazole dosing in early 2018.
PUR1900 has already received an Orphan Drug designation and a Qualified Infectious Disease Product(QIDP) designation from the FDA for the treatment of fungal infections in patients with cystic fibrosis. These two designations together provide up to 12 years of market exclusivity for PUR1900 if approved for cystic fibrosis patients.
For more information on cystic fibrosis, go to www.cff.org.
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF) and severe asthma, and PUR1800, a narrow spectrum kinase inhibitor for patients with COPD. In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for COPD. Pulmatrix's product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.