Salarius Pharmaceuticals completes FDA Type B meetng for seclidemstat

Salarius Pharmaceuticals participated in a Type B End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to receive guidance regarding the development program for seclidemstat to treat Ewing sarcoma. The Company has received the final meeting minutes and is amending the current clinical trial protocol to reflect guidance agreed to with FDA during the EOP2 meeting. As previously reported on August 8, 2023, the Company retained Canaccord Genuity, LLC to lead a comprehensive review of strategic alternatives focusing on maximizing shareholder value including, but not limited to, an acquisition, merger, reverse merger, divestiture of assets, licensing or other strategic transactions involving the Company. Those activities are on-going and Salarius does not expect to disclose developments with respect to this process unless and until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded that disclosure is appropriate or legally required. While these efforts are on-going, the Company continues to support the continuation of its protein inhibition and protein degradation programs as appropriate. Based on the advice received from the FDA and the new clinical data Salarius shared during the meeting process, Salarius is preparing an amendment to the Ewing sarcoma clinical trial protocol and plans to submit the amended protocol in the coming months. Salarius is currently evaluating strategic options to advance the clinical development of seclidemstat with a third party. The Company believes that the guidance provided by the FDA will support continued development by a potential partner or acquirer. The Company-sponsored Ewing sarcoma clinical trial focuses on seclidemstat in combination with topotecan and cyclophosphamide chemotherapy as a treatment for relapsed and refractory Ewing sarcoma. As of June 2023, a total of 13 relapsed Ewing sarcoma patients, including five patients with first relapse and eight patients with second relapse, were enrolled at seclidemstat doses of 600 mg or 900 mg twice daily in combination with TC chemotherapy. The five first-relapse patients demonstrated a 40% objective response rate and a 60% disease control rate including a complete response, partial response and stable disease. Among the three patients achieving DCR, the median progression-free survival has not been reached with these patients still having disease control at 14.5, 19.7 and 22.8 months, and increasing, after starting seclidemstat + TC combination treatment. The eight second-relapse patients demonstrated a 12.5% ORR, a 25% DCR, and a mPFS of 1.6 months; The 13 first- and second-relapse patients, combined, demonstrated a median survival of 8.1 months. Five patients, or 38%, achieved confirmed disease control and progression has not been observed in any of these confirmed disease control patients while on study.