Salarius Pharmaceuticals sees withdrawals, 3 of 13 patient responders in sarcoma trial
The Houston-based biotech Salarius Pharmaceuticals is lifting the cover on data from a Phase I/II trial for a drug currently on voluntary hold after a patient death, and the results appear to have underwhelmed investors.
Salarius’ candidate, dubbed seclidemstat, is an oral LSD1 inhibitor that is meant to treat Ewing sarcoma and FET-rearranged sarcomas in patients under 12 years old. The biotech had presented data with 13 patients with “first- and second-relapse Ewing sarcoma” who were treated in combination with topotecan and cyclophosphamide.
In the study, researchers saw one complete response and two partial responses out of 13 total patients. Execs attempted to paint a more positive picture in highlighting an additional three patients with “stable disease,” though that is not generally something that concerns the FDA when it comes to approvals.
Salarius also reported several withdrawals from the trial, as two patients bowed out after just three months, including all three confirmed responders. The company did note that two of the responders came from five patients who had relapsed for the first time.
The data reveal comes after the company paused enrollment and a patient death was reported in October. Salarius reported that the pause was due to a “suspected unexpected serious adverse reaction,” known as a SUSAR, that was observed in the sarcoma trial. The FDA has agreed with the voluntary hold and is working with the company to analyze the available data to figure out how best to proceed.
Despite the data, Salarius is apparently still looking to forge ahead, according to senior management. “These interim results are encouraging, and I believe they show the potential for seclidemstat to provide a more durable response among Ewing sarcoma patients when used in combination with topotecan and cyclophosphamide,” Salarius CEO David Arthur said in a statement.
And the interim results have not exactly been a boon for the company’s investors as well. The stock $SLRX is currently down around 5% since opening on Friday and is down 86% since the start of the year, now sitting at an estimated $1.80 per share.