Schrödinger announced the discontinuation of the clinical development program for SGR-2921, its CDC7 inhibitor, which was being evaluated in a Phase 1 dose-escalation study in patients with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.
Despite early evidence of monotherapy activity observed in the Phase 1 study, based on the profile observed to date, including two emergent events where SGR-2921 was considered to have contributed to two deaths in patients with AML, Schrödinger believes the path to development as a combination therapy would be difficult to pursue. The Phase 1 study was supported by preclinical data which had demonstrated that CDC7 inhibition resulted in monotherapy and combination anti-leukemic responses in patient-derived AML models, suggesting that SGR-2921 could ultimately be used in combination with standard of care agents.
“Patient safety is our first priority, and in light of two treatment-related deaths in the Phase 1 dose-escalation study, we have made the decision to discontinue further development of SGR-2921. While disappointing given the early clinical activity observed, we believe this is the right decision for patients,” stated Margaret Dugan, M.D., chief medical officer at Schrödinger. “We had hoped to advance this investigational agent for acute myeloid leukemia as relapse rates are high, the disease progresses rapidly and there are limited therapies available. We are very grateful to the investigators, patients and families who have participated in this clinical study.”
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