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.
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About Pulmonary Aspergillosis
The incidence of pulmonary fungal infections has increased substantially over the past two decades; Aspergillus species being the most common of these. Invasive pulmonary aspergillosis is associated with a high mortality and morbidity in immuno‑compromised patients, for example, those undergoing haematological stem cell or solid organ transplantation, (particularly lung transplants) and some patients in critical care. Aspergillus infection also plays an important role in severe asthma and cystic fibrosis and has been correlated with poorer clinical outcome in patients with chronic obstructive pulmonary disease. Chronic lung infections with Aspergillus can leave patients with extensive and permanent lung damage, requiring lifetime antifungal treatment.
PC945 is a novel inhaled triazole antifungal agent which is being developed to treat or prevent pulmonary fungal disease. PC945 has been specifically designed for inhalation. Its characteristics enable high lung absorption and retention, with minimal uptake into the systemic circulation. This ensures the delivery of a high concentration of the drug directly to the site of infection while minimizing the potential for systemic toxicities and drug interactions. The profile of PC945 has been assessed in a range of in vitro and in vivo studies in which it has been demonstrated to have potent antifungal activity against Aspergillus and Candida species and a range of other fungi. Available clinical data thus far indicate that PC945 is well tolerated and that systemic drug concentrations are extremely low.
Pulmocide Ltd (http://pulmocide.com/) is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapies for life-threatening lung infections. Our lead program, PC945, is a novel, inhaled, antifungal agent for the management of pulmonary fungal diseases which has the potential to address multiple indications. In 2021 we anticipate initiating a Phase 3 clinical trial for the treatment of second-line, invasive pulmonary Aspergillus disease as part of a combined antifungal regimen. The company is also considering the potential of PC945 to prevent pulmonary fungal disease in at-risk patients and as a treatment for chronic Aspergillus infections.
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