Pulmocide, a late-stage biopharmaceutical company focused on the development of a novel inhaled azole therapy for patients at risk of developing serious complications associated with aspergillosis, announced a $3.5 million investment from the Cystic Fibrosis Foundation for the development of opelconazole for lung transplant recipients.
People with cystic fibrosis (CF), particularly those who have undergone lung transplants, are highly susceptible to invasive Aspergillus fungal infections in their airways. Opelconazole is a novel azole specifically designed for inhaled use to prevent and treat pulmonary aspergillosis with potentially fewer side effects than standard-of-care azole treatments.
The CF Foundation’s funding will support a multicenter Phase 2 study of Pulmocide’s opelconazole. The study will assess the treatment’s safety and tolerability when used to prevent invasive pulmonary fungal infections in lung transplant recipients.
“The CF Foundation’s support to further the development of opelconazole as a vital option for the prevention or treatment of pulmonary aspergillosis in people living with cystic fibrosis who have received a lung transplant is greatly appreciated,” said Lance Berman, MD, chief medical officer of Pulmocide, in a statement. “In addition to those individuals with CF who have received a lung transplant, we believe that opelconazole may also be useful in treating those with CF who are suffering from chronic pulmonary aspergillosis. We are privileged to be working with an organization that has already made an enormous difference in the lives of people with CF and we hope to be able to help them bring important new treatments to this community.”
The incidence of pulmonary fungal disease has increased substantially over the past two decades with Aspergillus species being the most common pathogen. Invasive Pulmonary Aspergillosis (IPA) is associated with high morbidity and mortality rates in immuno-compromised patients including those undergoing hematological stem cell or solid organ transplantation (particularly lung transplants) and some patients in critical care, including those with COVID-19-associated pulmonary aspergillosis.
Aspergillus infection also plays an important role in severe asthma and cystic fibrosis and has been correlated with poorer clinical outcomes in patients with chronic obstructive pulmonary disease. Chronic lung infections with Aspergillus can leave patients with extensive and permanent lung damage, requiring a lifetime of antifungal treatment
Pulmocide’s opelconazole is a potent novel azole therapy specifically designed for inhaled use to maximize the amount of drug in the lung while providing minimal systemic exposure. This profile is expected to enhance efficacy and reduce the toxicities and drug-drug interactions seen with systemic antifungal therapies, according to the company.
Opelconazole has the potential to be useful in a variety of conditions where Aspergillus has been implicated, including chronic pulmonary aspergillosis, cystic fibrosis, severe asthma, allergic bronchopulmonary aspergillosis, chronic pulmonary obstructive disease, severe flu, and post-COVID-19-associated lung damage.