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Clinical Trials

Foto: Axel Hamprecht

Current Clinical Trials


ClinicalTrials.gov Identifier: NCT03333005
An Open Label, Multicenter Study to determine the Safety and Pharmacokinetics of intravenous and oral APX001 in patients undergoing Chemotherapy for acute Myeloid Leukemia with Neutropenia
Sponsor: Amplyx Pharmaceuticals, San Diego, USA
EU Sponsor Representative: University of Cologne
APX001 is a first-in-class small molecule drug candidate that targets and inhibits the conserved fungal enzyme Gwt1, compromising fungal growth of major fungal pathogens, including Candida and Aspergillus. APX001 has been evaluated extensively in preclinical studies, and has demonstrated broad-spectrum activity against infections caused by common species of Candida and Aspergillus, including species that are intrinsically resistant to antifungal drugs, as well as activity against rare, hard-to-treat moulds including Fusarium, Scedosporium and fungi from the Mucorales order. Patients with compromised immune systems due to chemotherapy or other immune-compromising medical treatments are susceptible to these potentially deadly fungal infections, and there are over 600,000 cases of invasive fungal infections due to Candida, Aspergillus and rare moulds annually worldwide. Amplyx is developing both IV and oral formulations of APX001 to address the need for hospital administration, as well as continued dosage after hospital discharge. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to APX001 and has also designated APX001 as a Qualified Infectious Disease Product (QIDP) for the treatment of multiple fungal infections.
Link ClinicalTrials.gov: clinicaltrials.gov/ct2/show/NCT03333005


ClinicalTrials.gov Identifier: NCT03059992
Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)
Sponsor: Scynexis, USA
EU Sponsor Representative: University of Cologne
SCY-078, prepared by chemical modification of enfumafungin, is the lead clinical candidate identified from this platform technology and is being developed as a new intravenous (IV) and oral agent for the treatment of several fungal infections. SCY-078 is an inhibitor of fungal 1,3 – β -glucan and synthesis and shows antifungal activity against a wide range of clinically important fungi, including those that are resistant to azole drugs such as fluconazole.
Link: www.clinicaltrials.gov/ct2/show/NCT03059992