SynDevRx, Inc. today announced the opening of the Amelia-1 study and data from the first patient treated in its Phase 1b/2 clinical study testing the novel MetAP2 inhibitor evexomostat (aka SDX-7320) in combination with the PI3K inhibitor alpelisib (Piqray^®) and the estrogen receptor degrader (SERD) drug fulvestrant (Faslodex®) in breast cancer patients with metastatic disease and the PIK3CA gene mutation (NCT05455619 – Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a PIK3CA Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor).

Amelia™-1 Study is testing if evexomostat can improve patients’ safety and clinical response to a PI3K inhibitor plus an estrogen receptor degrader. Evexomostat, a novel MetAP2 inhibitor, controlled PI3K-induced hyperglycemia in the first study patient, consistent with pre-clinical data. Further, ctDNA data shows no evidence of residual PIK3CA mutation in blood after 6 weeks of treatment.