Opelconazole

Decision made after reviewing results of interim analysisLONDON, Jan. 07, 2026 (GLOBE NEWSWIRE) -- Pulmocide Ltd., (“the Company”), a late-stage biopharmaceutical company developing the investigational product, inhaled opelconazole, for patients suffering from serious acute and chronic respiratory diseases, today announced the decision to terminate its Opera-T Phase 3 Study with opelconazole in refractory Invasive Pulmonary Aspergillosis (IPA). This decision was based on an interim analysis for the purpose of a sample size recalculation when approximately 50% of the subjects had been randomized and had sufficient time to complete the Day 84 visit. The analysis showed a numerically lower favorable response rate and a numerically higher mortality rate in the opelconazole arm compared to the control arm. The study enrolled patients who were severely immunocompromised, most of whom had a life threatening underlying hematological malignancy or were recipients of a stem cell or solid organ transplant. Based on data available at the time of the interim analysis, a large majority of patients had also failed at least two prior antifungal regimens for their IPA before enrolling into the study. Causality assessments conducted by investigators by the time of the interim analysis did not attribute any patient death to the blinded study drug. Pulmocide will be conducting a thorough review of the unblinded data from this trial to determine potential next steps for the program and would like to sincerely thank all the patients and investigators for participating in the study. About PulmocidePulmocide 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. For further information, please contact: Pulmocide Contact:Jennifer Giottonini CayerChief Business Officer and Head of Corporate DevelopmentPulmocide Ltdjcayer@pulmocide.com

We met with management teams from several private biotech companies during last week's JPM Healthcare Conference. We highlight some of the more interesting names in this note (in alphabetical order): AltruBio, ARTHEx Biotech, Congruence Therapeutics, Ensho Therapeutics, Evox Therapeutics, Octant Bio, Odyssey Therapeutics, Paratus Sciences, Pulmocide, Sorriso Pharmaceuticals, and Stealth Biotherapeutics. •AltruBio: AltruBio is a company in the I&I space developing a subQ antibody targeting PSGL-1, a unique immune checkpoint target that regulates T-cell homeostasis. Lead asset ALTB-268 is designed to downregulate chronically activated T-cells and restore immune system homeostasis, and the anti-PSGL-1 mechanism could have broader potential across T-cell-mediated diseases. ALTB-268 is currently in development for UC (Ph2a) and Psoriatic Arthritis (Ph2a planned). •ARTHEx Biotech: ARTHEx is a company in the rare neuromuscular space developing a potentially differentiated DM1 therapy. Lead asset ATX-01 is an ASO targeting miR-23b, designed to modulate the important MBNL and DMPK protein targets. ATX-01 is currently in a Ph1/2 trial in DM1, and initial results could be available in 2H25. Additional ATX-01 indications include DM2 (preclinical) and congenital DM1 (preclinical). •Congruence Therapeutics: Congruence is utilizing its proprietary Revenir™ computational discovery platform to identify novel binding sites for small molecule correctors of difficult-to-target genetically-validated, pathogenic proteins. The preclinical pipeline includes programs in Genetic Obesity (MC4R target), GBA Parkinson's (GCase target) and Alpha1-Antitrypsin Deficiency (AAT target). •Ensho Therapeutics: Ensho is a company in the I&I space developing a potential best-in-class oral α4β7 inhibitor for UC/Crohn's that could be a competitor to TAK's Entyvio (anti-α4β7 antibody) and LLY's ORF-057 (oral α4β7 inhibitor, MORF acquisition for $3.2B in 2024). Lead asset NSHO-101 is set to start a Ph2 trial in UC in 1H25 and a Ph2 trial in Crohn's could follow in 2027. •Evox Therapeutics: Evox is developing proprietary exosome therapeutics to treat rare genetic disorders. The preclinical pipeline includes Spinocerebellar Ataxia Type 2 (SCA2) and Amyotrophic Lateral Sclerosis (ALS) programs. •Octant Bio: Octant is leveraging its proprietary Navigator platform to design oral small molecule correctors of difficult-to-target proteins. Preclinical programs include Retinitis Pigmentosa (RHO-adRP), Fabry Disease, and p53 cancers. •Odyssey Therapeutics: Odyssey is a company in the I&I space and is developing a suite of novel small-molecule and protein therapeutics. Lead program OD-07656 is an oral RIPK2 inhibitor in development for UC/Crohn's. The company filed an S-1 on 1/17/25. •Paratus Sciences: Paratus is a preclinical-stage company in the I&I and cardiometabolic space. The company is leveraging its proprietary bat genomics/transcriptomics library to identify novel, human-relevant therapeutic targets. •Pulmocide: Pulmocide is developing nebulized opelconazole for the treatment of refractory invasive fungal infections in the lung. Opelconozole, a novel azole antifungal, has shown positive efficacy and safety results in Ph2 and compassionate use trials across multiple indications. A Ph3 superiority trial vs SoC in invasive pulmonary aspergillosis is ongoing, with data expected in 2026. •Sorriso Pharmaceuticals: Sorrisso is a clinical-stage company in the I&I space, developing novel, oral "vorabodies" designed towards multi-targeting for higher efficacy and lower systemic safety risk. Lead asset SOR102 is a gut-directed dual-targeting TNFα/IL-23 oral antibody in Ph2a development in UC/Crohn's. •Stealth Biotherapeutics: Stealth is a clinical-stage company developing mitochondria-targeted therapies. Lead asset elamipretide is under FDA review for treating the ultra-rare cardioskeletal disease Barth Syndrome (4/29/25 PDUFA). A Ph1 trial for pipeline asset bevemipretide (dry AMD) could start in 1H25. View Full Report with Disclaimers Find More top More News