MTX240 (OPB-171775)
- Indication
- Gastrointestinal stromal tumors (GIST)
- Stage
- phase3
- Event
- Submission
- Details
September 11, 2026: Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) reported interim 1H26 results and highlighted multiple catalyst updates across its pipeline. eRapa (MTX230) in familial adenomatous polyposis (FAP): the registrational Phase 3 Serenta trial (NCT06950385), initiated in June 2025 after FDA Type C and EMA advice, is enrolling 168 high-risk FAP patients with first progression-free survival event as the primary endpoint. As of publication, 92 patients were enrolled across 29 centers in the US and Europe; Health Canada approved expansion into Canada in June 2026, with two Canadian sites expected to begin enrolling in 4Q26. An Early Access Program for FAP patients launched in March 2026 via Tanner Pharma. eRapa in NMIBC: the investigator-initiated Phase 2 trial (NCT04375813) is fully enrolled at 166 patients and is expected to read out in Q4 2026. MTX240 in GIST: Biodexa licensed the program from Otsuka in February 2026; it is preparing a pre-IND submission to FDA and restarting a Phase 1 dose-escalation/dose-optimization trial, with the CEO saying the company aims to establish dose and an efficacy signal before end-2027. Tolimidone (MTX228) in type 1 diabetes: investigator-initiated Phase 2a study enrolled its first patient in June 2025. Post-period, Biodexa raised $3.5 million on July 1, 2026, but said further financing will be required in Q4 2026.
- Source
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