Pulmocide announces the initiation of a double-blind, placebo-controlled study to evaluate the effects of PC945 on fungal burden in a moderate-severe asthma population with Aspergillus fumigatus infection. PC945 will be administered by inhaled administration for 28 days and study outcome will be measured using mycological and clinical endpoints.
PC945 is a novel triazole antifungal agent which has been developed as an inhaled treatment for pulmonary infections caused by Aspergillus fumigatus. The profile of PC945 has been assessed in a range of in vitro and in vivo studies where it has been demonstrated to have potent anti-fungal activity against A. fumigatus, Candida albicans and a range of other fungi*. PC945 has been designed to deliver prolonged retention in lung tissue, making once daily dosing feasible.PC945 exhibits excellent safety and tolerability in phase 1. Following inhaled delivery, local concentrations of PC945 in the lung are high, with extremely low systemic concentrations.
About Aspergillus infection in patients with asthma
Aspergillus is frequently identified in the airways of patients with asthma. In patients with severe asthma, inhaled conidia of A. fumigatus germinate into hyphae with release of antigens which activate the innate and adaptive immune responses leading to sensitization in the airways. Sensitization to Aspergillus has been linked to airflow obstruction, exacerbations, hospital admissions and requirement for high doses of corticosteroids.
Due to the significant toxicity of currently available antifungal agents, the long-term risk of treating Aspergillus with oral therapies may outweigh the potential benefits. Treatment with potent inhaled PC945 is intended to avert systemic toxicities whilst maintaining high local concentrations in the bronchial airways.