Cystic Fibrosis Foundation Therapeutics has given Pulmatrix a grant to test the safety of PUR1900 as a treatment for allergic bronchopulmonary aspergillosis (ABPA) in cystic fibrosis and asthma patients.
The grant will allow Pulmatrix to assess the safety of the anti-fungal drug this fall, paving the way for a Phase 1/1B trial in 2018. In announcing the grant, the company but did not specify the amount.
ABPA is a lung infection caused by a fungus called Aspergillus fumigatus that is present in the air we breathe. Most people can clear the fungus out of their respiratory tracts. But CF and asthma patients with compromised lung function or immune systems are less able to clear out the fungus. This makes them more susceptible to allergic reactions to it and lung infections stemming from it.
Anti-fungal drugs for treating ABPA are available, but they are taken orally. Oral drugs are not very effective against ABPA.
In addition, high doses are needed to get enough of the drugs into the bloodstream and then to the lungs. These high doses can cause serious side effects, including liver toxicity.
In PUR1900, Pulmatrix has combined an anti-fungal drug, called itraconazole, with the company’s inhaled iSPERSE dry powder. The company developed iSPERSE, which stands for inhaled small particles easily respirable and emitted, to improve the treatment of serious pulmonary diseases.
Because iSPERSE is inhaled, a lot of the drug can reach the lungs directly, where it is needed, instead of reaching the lungs through the bloodstream, as in the case of oral drugs.
“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,” Robert Clarke, Pulmatrix’s CEO, said in a press release. “It underscores the potential for PUR1900 to treat this serious condition [ABPA], which is currently a major unmet medical need.”
The U.S. Food and Drug Administration granted PUR1900 orphan drug designation in 2016, and Qualified Infectious Disease Product designation in January 2017 as a treatment for fungal infections in patients with CF. Together, these designations provide up to 12 years of marketing exclusivity for PUR1900 if the therapy is approved.