Schrödinger has announced the discontinuation of the clinical development programme for SGR-2921, its CDC7 inhibitor, which was being evaluated in a Phase I dose-escalation study in patients with relapsed/refractory acute myeloid leukaemia or high-risk myelodysplastic syndromes.
Despite early evidence of monotherapy activity observed in the Phase I 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 I study was supported by preclinical data that had demonstrated that CDC7 inhibition resulted in monotherapy and combination anti-leukaemic 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 I dose-escalation study, we have decided to discontinue further development of SGR-2921."
"Although disappointing given the early clinical activity observed, we believe this is the right decision for patients,” stated Margaret Dugan, MD, Chief Medical Officer at Schrödinger.
“We had hoped to advance this investigational agent for acute myeloid leukaemia, 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.”