Salarius Completes FDA Type B Meeting for Seclidemstat Ewing Sarcoma Development Program
FDA briefing included new Ewing sarcoma clinical data from ongoing investigation where 60% of first-relapse patients achieved disease control and have not progressed after at least 14.5, 19.7 and 22.8 months
Future development activities were identified; Salarius intends to submit an amended Ewing sarcoma clinical trial protocol
As previously reported on
“Our objective in meeting with the FDA was to gain clarity on next steps and the potential approval pathway for seclidemstat, topotecan and cyclophosphamide combination therapy for the treatment of first-relapse Ewing sarcoma patients, a patient population in dire need of better therapeutic options,” said
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 (TC) chemotherapy as a treatment for relapsed and refractory Ewing sarcoma. As of
- The five first-relapse patients demonstrated a 40% objective response rate (ORR) and a 60% disease control rate (DCR) including a complete response, partial response and stable disease. Among the three patients achieving DCR, the median progression-free survival (mPFS) 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 (range: 0.0 months to 10.7 months).
- The 13 first- and second-relapse patients, combined, demonstrated a median survival of 8.1 months (range: 2.0 months to 22.8 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.
Seclidemstat is a novel oral reversible inhibitor of the LSD1 enzyme and has received fast track, orphan drug and rare pediatric disease designations for Ewing sarcoma from the FDA. In addition to the Ewing sarcoma clinical trial, Salarius is also exploring seclidemstat’s potential in several cancers with high unmet medical need, with an investigator-initiated Phase 1/2 clinical study in hematologic cancers at
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements may be identified by terms such as “will,” “believe,” “developing,” “expect,” “may,” “progress,” “potential,” “could,” “look forward,” “encouraging,” “might,” “should,” and similar terms or expressions or the negative thereof. Examples of such statements include, but are not limited to, statements relating to the following: Salarius’ expectations regarding the exploration of strategic alternatives, opportunities to extend Salarius’ resources, the future of the Company’s operations and product candidates; the future of the Company’s preclinical studies and clinical trials and development activities; the advantages of protein degraders including the value of SP-3164 as a cancer treatment; the value of seclidemstat as a treatment for Ewing sarcoma, Ewing-related sarcomas, and other cancers and its ability to improve the life of patients;. Salarius may not actually achieve the plans, carry out the intentions or meet the expectations or objectives disclosed in these forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements are subject to risks and uncertainties which could cause actual results and performance to differ materially from those discussed in the forward-looking statements. These risks and uncertainties include, but are not limited to, the following: the risk that exploration of strategic alternatives may not result in any definitive transaction or enhance stockholder value and may create a distraction or uncertainty that may adversely affect our operating results, business, or investor perceptions; expectations regarding future costs and expenses; our product candidates being in early stages of development; the uncertainty about the paths of our programs and our ability to evaluate and identify a path forward for those programs, particularly given the constraints we have as a small company with limited financial, personnel and other operating resources (including with respect to the allocation of our limited capital and the sufficiency of our capital in the near term for any path we do select); Salarius’ ability to continue as a going concern; the sufficiency of Salarius’ capital resources; availability of suitable third parties with which to conduct contemplated strategic transactions; whether the Company will be able to pursue a strategic transaction, or whether any transaction, if pursued, will be completed successfully and on attractive terms or at all; whether our cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital requirements; changes in the Company’s operating plans that may impact its cash expenditures; the uncertainties inherent in research and development, future clinical data and analysis; the risks associated with reductions in workforce, including reduced morale and attrition of additional employees necessary for the strategic reprioritization; future clinical trial results and the impact of such results on Salarius; that the results of studies and clinical trials may not be predictive of future clinical trial results; the competitive landscape and other industry-related risks; and other risks described in Salarius’ filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended
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Source: Salarius Pharmaceuticals, Inc.