Pulmocide Announces Presentation at 43rd Annual J.P. Morgan Healthcare Conference

LONDON, Jan. 10, 2025 (GLOBE NEWSWIRE) — Pulmocide Ltd., (“the Company”), a late-stage biopharmaceutical company developing inhaled opelconazole for patients suffering from serious acute and chronic respiratory diseases, today announced that Dan Burgess, Chief Executive Officer, will present a corporate update at the 43^rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025 from 5:00 p.m. – 5:25 p.m. PT in the Mission Bay Ballroom at The Westin in San Francisco.

About Opelconazole
Pulmocide’s investigational product, opelconazole, is currently in a Phase 3 clinical trial (NCT05238116) in patients with Invasive Pulmonary Aspergillosis (IPA) who are not responding to antifungal therapy (OPERA-T study).¹ Opelconazole is also, being supplied within the United Kingdom to patients with serious or life-threatening pulmonary aspergillosis in accordance with the MHRA’s Guidance Note 14 (the Specials program).² Although drawing definitive conclusions regarding efficacy and safety from this program is limited by the open-label, non-randomized, uncontrolled nature of the program, observations suggest that in this program, inhaled opelconazole was generally well tolerated and effective in treating these patients.^{3, 4, 5} These clinical observations were noted in patients who had failed, or were intolerant of, prior antifungal therapy and were the rationale for initiation of the Phase 3 program.

Pulmocide recently completed a Phase 2 safety and tolerability clinical trial (OPERA-S study) in lung transplant patients receiving inhaled opelconazole monotherapy as prophylaxis against pulmonary aspergillosis. Results from this study further support opelconazole’s potential to be used as prophylaxis in immunocompromised patients at risk of developing pulmonary aspergillosis, most commonly patients with an underlying hematological malignancy or recipients of a stem cell or solid organ transplant.

Opelconazole is a potent novel investigational azole therapy specifically designed for inhaled use to maximize the amount of drug in the lung while providing minimal systemic exposure. This profile is anticipated to enhance efficacy with a low risk of adding to the toxicities and drug-drug interactions seen with systemic antifungal therapies. Opelconazole has Orphan Drug (US and EU), Fast Track, and Qualified Infectious Disease Product (QIDP) designations.

Opelconazole has the potential to be useful in a variety of additional conditions where Aspergillus has been implicated, including chronic pulmonary aspergillosis, patients with severe asthma complicated by allergic bronchopulmonary aspergillosis (ABPA), and severe flu or COVID-19 complicated by invasive aspergillosis.

About Pulmonary Aspergillosis
The incidence of pulmonary fungal disease has increased substantially over the past two decades with Aspergillus species being the most common pathogen.⁶ Invasive pulmonary aspergillosis is associated with high morbidity and mortality rates in immunocompromised 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 or influenza-associated pulmonary aspergillosis.⁶ 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.⁶ Chronic lung infections with Aspergillus can leave patients with extensive and permanent lung damage, requiring a lifetime of antifungal treatment.⁶

About Pulmocide
Pulmocide Ltd (www.pulmocide.com) is 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, such as immunocompromised patients and those with severe pulmonary diseases. The company is currently focused on acute and chronic treatments for pulmonary aspergillosis and its lead Phase 3 product opelconazole is being developed initially for the treatment of invasive pulmonary aspergillosis.

References:

1. https://www.clinicaltrials.gov/study/NCT05238116?term=opelconazole&rank=2
2. MHRA. (2014). The supply of unlicensed medicinal products (“specials”). Retrieved from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/373505/ The_supply_of_unlicensed_medicinal_products__specials_.pdf
3. Murray, A., Cass, L., Ito, K., et al. (2020). PC945, a Novel Inhaled Antifungal Agent, for the Treatment of Respiratory Fungal Infections. J Fungi (Basel), 6(4). https://doi.org/10.3390/jof6040373
4. Pagani, N., Armstrong-James, D., & Reed, A. (2020). Successful salvage therapy for fungal bronchial anastomotic infection after -lung transplantation with an inhaled triazole anti-fungal PC945. J Heart Lung Transplant, 39(12), 1505-1506. https://doi.org/10.1016/j.healun.2020.09.015
5. Singh, S., Moore, L. S. P., Mughal, N., et al. (2023). Novel inhaled antifungal for pseudomembranous Aspergillus tracheobronchitis complicating connective tissue disease. Thorax, 78(1), 110-111. https://doi.org/10.1136/thorax-2021-218375
6. Kousha, M., Tadi, R., Soubani, A. O. (2011). Pulmonary aspergillosis: a clinical review. European Respiratory Review, 20 (121), 156-174. https://doi.org/10.1183/09059180.00001011

For further information, please contact:

Pulmocide Contact:
Jennifer Giottonini Cayer
Chief Business Officer and Head of Corporate Development
Pulmocide Ltd
jcayer@pulmocide.com

Media Contact:
Michael Tattory
LifeSci Communications
mtattory@lifescicomms.com