fosmanogepix (APX001) / Basilea, Pfizer - LARVOL DELTA

A Study of Fosmanogepix in Healthy Adult Chinese Subjects (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: Basilea Pharmaceutica

New P1 trial

A Novel Clinical Presentation: First Documented Case of Candida Auris Empyema Thoracis (ATS 2025) - "He was found to have pneumonia due to Pseudomonas, and was treated with parenteral cefepime...He was treated with meropenem, vancomycin, anidulafungin, and liposomal amphotericin B. The pleural C. auris strain was susceptible to anidulafungin (MIC = 0.25 ug/ml)...We await the results of ongoing clinical trials with newly developed phase 2 clinical trial antifungal agents such as fosmanogepix, ibrexafungerp, and T-2307, a novel arylamidine, for advances in anti-C. auris treatment options."

Clinical • Acute Kidney Injury • Diabetes • Diabetic Nephropathy • Infectious Disease • Metabolic Disorders • Pneumonia • Renal Disease • Respiratory Diseases • Septic Shock

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections. (clinicaltrials.gov) - P3 | N=219 | Not yet recruiting | Sponsor: Basilea Pharmaceutica

New P3 trial • Infectious Disease

Fosmanogepix for the Treatment of Invasive Mold Diseases Caused by Aspergillus Species and Rare Molds: A Phase 2, Open-Label Study (AEGIS). (PubMed, Clin Infect Dis) - P2 | "Safety profile was acceptable in high-risk patients with limited treatment options, supporting development of FMGX for treating IMDs caused by Aspergillus and rare molds."

Journal • P2 data • Infectious Disease

CASE SERIES OF INVASIVE FUSARIOSIS IN HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS WITH HIGHLY FAVORABLE OUTCOMES IN SETTING OF TREATMENT WITH FOSMANOGEPIX: A SINGLE-CENTER EXPERIENCE (EBMT 2025) - "Risk factors for fungal infection: 3 received PTCY, 1 – prednisone for engraftment syndrome (AP-Isavuconazole), 1 - acute graft versus host disease (GVHD) requiring high-dose steroids and basiliximab (AP-Posaconazole), and in 2 low dose steroids along with calcineurin inhibitor and mycophenolate mofetil (AP-Micafungin)...Initial antifungal regimen included upfront liposomal amphotericin B (L-AMB). Combination of voriconazole used in 2, micafungin in 1 and LAMB monotherapy in 1... This cohort of highly immunocompromised HCT patients with IF developing in first 100 days post-HCT treated with fosmanogepix monotherapy had favorable clinical outcomes with no deaths at 6 or 12 weeks post IF diagnosis."

Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Otorhinolaryngology • Pain • Respiratory Diseases • Sinusitis • Transplantation

CASE SERIES OF INVASIVE FUSARIOSIS IN HEMATOPOIETIC CELL TRANSPLANT RECIPIENTS WITH HIGHLY FAVORABLE OUTCOMES IN SETTING OF TREATMENT WITH FOSMANOGEPIX: A SINGLE-CENTER EXPERIENCE (EBMT 2025) - "Risk factors for fungal infection: 3 received PTCY, 1 – prednisone for engraftment syndrome (AP-Isavuconazole), 1 - acute graft versus host disease (GVHD) requiring high-dose steroids and basiliximab (AP-Posaconazole), and in 2 low dose steroids along with calcineurin inhibitor and mycophenolate mofetil (AP-Micafungin)...Initial antifungal regimen included upfront liposomal amphotericin B (L-AMB). Combination of voriconazole used in 2, micafungin in 1 and LAMB monotherapy in 1... This cohort of highly immunocompromised HCT patients with IF developing in first 100 days post-HCT treated with fosmanogepix monotherapy had favorable clinical outcomes with no deaths at 6 or 12 weeks post IF diagnosis."

Clinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Myelodysplastic Syndrome • Neutropenia • Oncology • Otorhinolaryngology • Pain • Respiratory Diseases • Sinusitis • Transplantation

Fosmanogepix expanded access case series in patients with mucormycosis (ESCMID Global 2025) - No abstract available

Clinical • Infectious Disease

Fosmanogepix - a novel clinical phase 3 stage antifungal agent (ESCMID Global 2025) - "Organized by BASILEA"

Clinical • P3 data

IPT13 - Fosmanogepix - a novel clinical phase 3 stage antifungal agent (ESCMID Global 2025) - "In 2023, the CDC recommended fosmanogepix as treatment option in an outbreak of Fusarium meningitis. The FDA granted Fast Track, Orphan Drug, and QIDP designations."

Clinical • P3 data • Candidiasis • CNS Disorders • Infectious Disease

Fosmanogepix expanded access in patients with Fusarium infections (ESCMID Global 2025) - No abstract available

Clinical • Infectious Disease

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Basilea Pharmaceutica | Trial primary completion date: Feb 2025 ➔ May 2025

Trial primary completion date • Hepatology

Antifungal pipeline: New tools for the treatment of mycoses. (PubMed, Rev Iberoam Micol) - "New antifungal agents, such as ibrexafungerp, rezafungin, oteseconazole, and miltefosine, offer novel mechanisms of action along with reduced toxicity...This review provides a comprehensive overview of these new agents and their mechanisms, and explores the challenges and roles of antifungal drugs in LMICs, where the burden of fungal infections is high. Continued research and development are essential to address the rising incidence and resistance of fungal infections globally."

Journal • Dermatology • Infectious Disease

Basilea reports strong 2024 full-year results with significant increase in revenue, profit and operating cash flow (GlobeNewswire) - "For the full year (FY) 2024, Basilea recognized total revenue of CHF 208.5m (FY 2023: CHF 157.6m). This included royalty income of CHF 96.7m (FY 2023: CHF 78.9m) from Cresemba, which increased by 22.6% year-on-year, and product revenue of CHF 57.8m (FY 2023: CHF 37.9m), which increased by 52.5% year-on-year...Other revenue amounted to CHF 13.7m (FY 2023: CHF 7.4m). This included CHF 10.2m BARDA reimbursements (FY 2023: CHF 4.2m) for remaining activities related to the phase 3 program for ceftobiprole and under the Other Transaction Agreement (OTA) executed in September 2024. In 2024, Basilea invested CHF 77.1m (FY 2023: CHF 77.9m) in research and development, mainly for the phase 3 program with fosmanogepix, the preclinical profiling of BAL2062 and tonabacase, the acquisition and preclinical activities for the LptA inhibitor program, the remainder of the phase 3 ceftobiprole program and for research work on compounds in the Company’s early-stage portfolio."

Commercial • Infectious Disease • Pneumonia

Basilea reports strong 2024 full-year results with significant increase in revenue, profit and operating cash flow (GlobeNewswire) - "In 2025, we will focus on further advancing our portfolio, first by starting the second phase 3 study with our potential next lead product, fosmanogepix, in mold infections. In addition, we are continuing the preclinical work with the antifungal BAL2062 and the LptA inhibitor antibiotic, BAL2420, in preparation for the subsequent clinical studies, planned to start in 2026. For the early-stage asset tonabacase, we have completed our pre-clinical profiling and taken the decision not to pursue further development."

Discontinued • New P3 trial • Candidiasis • Infectious Disease

An update on newer antifungals. (PubMed, Expert Rev Anti Infect Ther) - "New antifungal agents hold promising future for difficult-to-treat fungal infections, providing for improved bioavailability, pharmacokinetic properties, adverse events and drug interactions, as well as, spectrum of activity. However, further data is needed before incorporating these agents in everyday clinical practice for the management of invasive fungal infections."

Journal • Review • Candidiasis • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Basilea provides portfolio update and outlook (GlobeNewswire) - "In September, we commenced a phase 3 study with fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, i.e. severe invasive yeast infections. A second phase 3 study, in invasive mold infections, is expected to start in the coming months."

New P3 trial • Trial status • Infectious Disease

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Basilea Pharmaceutica | Trial completion date: Dec 2024 ➔ Mar 2025

Trial completion date • Hepatology

A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis. (clinicaltrials.gov) - P3 | N=450 | Recruiting | Sponsor: Basilea Pharmaceutica | Not yet recruiting ➔ Recruiting

Enrollment open • Candidiasis

New pharmacotherapeutic strategies for drug-resistant candida infections: a review. (PubMed, Expert Opin Pharmacother) - "This review with discuss the various Candida species, especially the non-albicans species, some of the important mechanisms of resistance, and newer in vitro and clinical studies describing the recent and novel antifungal options such as rezafungin, ibrexafungerp, and oteseconazole, along with a novel antifungal, fosmanogepix. The newer and novel antifungals discussed here will add valuable tools to our antifungal armamentarium to be able to appropriately and adequately treat and manage these difficult infections. Each of the antifungals has unique and novel properties that will expand the arsenal useful to treat these fungal infections in the years to come."

Journal • Review • Candidiasis • Infectious Disease

Fosmanogepix, Basilea Pharmaceutica International Ltd, Allschwil (Switzerland) (IDWeek 2024) - No abstract available

Human Immunodeficiency Virus • Infectious Disease

Usage of Antifungal Agents in Pediatric Patients Versus Adults: Knowledge and Gaps. (PubMed, Mycopathologia) - "The oral formulations of ibrexafungerp, fosmanogepix and olorofim along with the extended dosing intervals of rezafungin show promising features for effective antifungal treatment in pediatrics. Despite the promising potential of novel antifungal drugs, their performance in heavily immunosuppressed patients remains unstudied. Until then, dedicated antifungal stewardship programs for high-risk patients are essential to optimize therapeutic outcomes, improve patient care, and limit the emergence of resistance."

Journal • Review • Infectious Disease • Pediatrics

Two cases of fungemia due to Lomentospora prolificans in haematological patients with different outcome. (PubMed, Diagn Microbiol Infect Dis) - "The current treatment is still based on a combination of conventional antifungal drugs, although in much cases this strategy is not sufficient. The introduction of new promising antifungal agents such as fosmanogepix® and olorofim® may open new perspectives in the treatment of invasive infections caused by L. prolificans, as in our patient."

Journal • Hematological Disorders • Hematological Malignancies • Infectious Disease • Neutropenia • Oncology

Reassessment of the role of combination antifungal therapy in the current era. (PubMed, Curr Opin Infect Dis) - "There is a need to investigate the use of combination antifungal agents. This includes delineating the indication of these combined antifungal therapies and determining how to use them most appropriately in the clinical setting."

Journal • CNS Disorders • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Update on diagnosis and treatment of fungal meningitis: lessons from recent outbreaks. (PubMed, Curr Opin Infect Dis) - "Fungal meningitis outbreaks due to filamentous fungi are usually associated with direct epidural inoculation. They result in severe presentations and high mortality. Early diagnosis should be suspected, BD-Glucan CSF testing screening is recommended. Aggressive antifungal treatment based on antifungal susceptibility testing should be administered as early as possible. The advent of molecular diagnostic methods and new antifungal drugs may allow for timely diagnosis and treatment, increasing the chances of survival."

Journal • Anesthesia • CNS Disorders • Infectious Disease

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function. (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Basilea Pharmaceutica | Active, not recruiting ➔ Recruiting | N=18 ➔ 24

Enrollment change • Enrollment open • Hepatology