Pulmocide announces publication of clinical data in two peer-reviewed publications highlighting potential of PC945, a novel inhaled antifungal drug candidate, in lung infections

Pulmocide announces publication of clinical data in two peer-reviewed publications highlighting potential of PC945, a novel inhaled antifungal drug candidate, in lung infections

• Case studies featuring two lung transplant patients in the Journal of Heart and Lung Transplantation show nebulized delivery of PC945 resulted in complete resolution of refractory Aspergillus infection
• Pharmacokinetic and safety profiles from nonclinical studies and clinical trials published in Pharmaceutical Research and Perspectives

London, UK, 11 March 2021 – Pulmocide Ltd., which is developing first-in-class inhaled anti-infectives for targeted treatment of life-threatening lung infections, today announces the publication of two papers in key scientific journals featuring Pulmocide’s lead drug candidate, PC945.

PC945 is the first triazole antifungal specifically designed for delivery to the lung via inhalation and is currently being developed for the treatment of invasive pulmonary Aspergillus disease, a potentially life-threatening complication in immunocompromised patients. 

The first paper, published in the Journal of Heart and Lung Transplantation, outlines case studies of two patients who underwent a lung transplant and subsequently developed serious, life-threatening Aspergillus infection at the anastomotic site (where the patient’s airways join the airway of the donor lung). In both patients the disease had continued to progress despite months of treatment with a series of approved antifungals. The paper, entitled Successful salvage therapy for fungal bronchial anastomotic infection after lung transplantation with an inhaled triazole anti-fungal PC945, describes the rapid and complete resolution of the infection in both patients after nebulized PC945 was commenced.

The full publication is available online and can be viewed here: https://www.jhltonline.org/article/S1053-2498(20)31762-9/fulltext

Dr Lance Berman, Chief Medical Officer of Pulmocide, commented: “Aspergillus infection is a devastating complication of lung transplantation which can lead to increased morbidity and mortality, and often these infections do not respond to current treatment options. Following inhaled delivery of PC945, the two patients highlighted in this paper showed complete resolution of the infection within three months indicating the potential of PC945 as a treatment option for Aspergillus infections.  We look forward to progressing PC945 to Phase 3 later this year.”

The second paper, Safety and nonclinical and clinical pharmacokinetics of PC945, a novel inhaled triazole antifungal agent, published in Pharmaceutical Research and Perspectives, reports data on the pharmacokinetic and safety profiles from nonclinical studies including the low potential for drug-drug interactions, and a Phase 1 clinical trial in healthy subjects and subjects with mild asthma following nebulised delivery of PC945.

The data show that PC945 was well-tolerated, and findings from clinical and nonclinical studies demonstrated that repeat daily doses of inhaled PC945 led to prolonged retention in the lung with minimal systemic exposure, limiting the potential for adverse events and drug interactions commonly seen with systemically delivered azoles. These data suggest that inhaled PC945 could have a much wider therapeutic index than systemic antifungal agents.

Dr Pete Strong, Chief Scientific Officer of Pulmocide, commented: “The Phase 1 study and non-clinical data described in the Pharmaceutical Research and Perspectives publication represents an important step in the characterisation of PC945 in lung tissue and systemic circulation and enables us to proceed into later stage clinical trials with confidence. We are excited to start our Phase 3 program this year and look forward to updating the scientific community on clinical progress in due course.”

The full publication is available online and can be viewed here: https://bpspubs.onlinelibrary.wiley.com/doi/10.1002/prp2.690

A Phase 3 program with PC945 is expected to start this year to assess the drug candidate in the treatment of second-line, invasive pulmonary Aspergillus disease as part of a combined anti-fungal regimen. The program will also evaluate the safety and pharmacokinetics of the drug when used as monotherapy in preventing Aspergillus disease in lung transplant patients.