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Biodexa Advances Peptide‑Derived Therapy eRapa in Phase 3 FAP Trial

Biodexa Advances Peptide‑Derived Therapy eRapa in Phase 3 FAP Trial

Biodexa Pharmaceuticals has reported interim results for the first half of 2026, highlighting progress in its peptide‑derived therapeutic eRapa, now in a registrational Phase 3 trial for Familial Adenomatous Polyposis (FAP).

Peptide Innovation in GI Cancer

eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor originally approved for transplant rejection. By using nanotechnology and pH‑sensitive polymers, Biodexa has engineered eRapa to overcome rapamycin’s poor bioavailability and toxicity profile. This peptide‑derived approach is protected by patents through 2035 and has already received orphan designation in the US and Europe.

The Serenta trial (NCT06950385) is enrolling 168 high‑risk FAP patients across the US, Europe, and soon Canada. As of publication, 92 subjects have been recruited, surpassing the halfway mark. CEO Stephen Stamp noted that “passing the 50% enrolment in early August puts us significantly ahead of any competitive development programs.”

Expanding the Pipeline

Beyond eRapa, Biodexa in‑licensed MTX240 from Otsuka in February. This “molecular glue” therapy targets gastrointestinal stromal tumors (GIST) by binding PDE3A and SLFN12 proteins to trigger apoptosis independent of KIT or PDGFR mutations. The company plans to restart a Phase 1 trial in resistant GIST patients, aiming for early efficacy signals before the end of 2027.

Financial Snapshot

R&D spending rose 75% year‑on‑year to £2.92 million, driven by Serenta trial activity and MTX240 manufacturing costs. Administrative costs fell to £1.74 million, while cash outflows from operations totaled £4.61 million. The company closed the half with £3.23 million in cash, later boosted by a $3.5 million raise in July.

The Bigger Picture

With no approved therapies for FAP, eRapa’s progress represents a potential breakthrough in peptide‑based oncology. At the same time, MTX240’s novel mechanism could address resistance in GIST, underscoring Biodexa’s strategy to build a portfolio of peptide‑related and protein‑interaction therapies in gastrointestinal cancers.

Related Coverage: The regulatory fight over peptide classification is heating up. See our coverage of Eli Lilly v. RFK Jr., where exclusivity rules could reshape the peptide drug landscape.

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