Salarius blood cancer study on partial hold in wake of serious adverse event
11 Jul 2024
Shares of Salarius Pharmaceuticals plunged by as much as 26% on Thursday following the company's disclosure of a partial clinical hold imposed by the FDA on its lead drug candidate seclidemstat (SP-2577), an oral LSD1 inhibitor in early testing for both haematological and solid tumours.
In a US regulatory filing Thursday, the company said researchers at MD Anderson Cancer Center (MDACC)Cancer Center (MDACC) notified them of a "serious and unexpected Grade 4 adverse event" in a patient participating in MDACC's sponsored trial. The study is evaluating seclidemstat in combination with azacitidine for adult patients with myelodysplastic syndromes (MDS) and chronic myelomonocytic leukaemia (CMML).
No new patients may be enrolled in the study during the partial hold, although currently enrolled subjects who are benefiting from the treatment may continue with the study procedures.
Salarius said it will support MDACC researchers in analysing the available data and responding to questions submitted by the FDA. It did not provide details on the nature of the Grade 4 adverse event, which typically refers to life-threatening or disabling side effects according to the National Cancer InstituteCancer Institute's classification.
Recent EHA readout
The setback comes just weeks after Salarius presented data on seclidemstat at the European Hematology Association (EHA) annual meeting. The Phase I/II dose-escalation study reported a 43% overall response rate among 14 predominantly higher-risk MDS and CMML patients who had previously failed or relapsed after hypomethylating agent therapy. Median overall survival was 18.5 months, with median event-free survival of 7.2 months.
At the time, board chair William McVicar said "we are encouraged by these promising results at this early stage of the study when seclidemstat is combined with azacitidine at doses below what we believe will be the recommended Phase II dose."
Seclidemstat is also being investigated in a Phase I/II company-sponsored study in Ewing sarcoma.
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