Coiled Therapeutics (AIM:COIL) enrolled patients across two dose-escalation cohorts of its new lipid-based formulation of AO-252, its brain-penetrant inhibitor of TACC3 for genetically defined cancers.
The clinical-stage precision oncology company, listed on AIM and OTCQB, said all six patients (three in a twice-daily 120mg cohort, three in a once-daily 160mg cohort) are progressing through the assessment period of its Phase I trial (NCT06136884).
The softgel formulation aims to fix an absorption problem: the original tablet version showed an 80% clinical benefit rate under twice-daily dosing (n=5) versus just 40% once daily (n=5), a gap the company attributes to inconsistent bioavailability rather than the drug's mechanism.
Coiled Therapeutics still expects to dose up to 30 patients with the new formulation by the end of 2026, feeding into planned Phase I/II expansion cohorts in ovarian and prostate cancer.
"This is an important step in de-risking our dose-escalation strategy and keeps us firmly on track to dose up to 30 patients by the end of the year", said chief executive Sridhar Vempati.
Initial safety and pharmacokinetic data are still expected by the end of 2026.
News Intelligence what this means for the company
Coiled Therapeutics has enrolled all six patients across two dose-escalation cohorts of its reformulated AO-252 softgel, staying on track to dose up to 30 patients by end-2026 and deliver initial safety and pharmacokinetic data in Q4. The reformulation targets a bioavailability problem in the original tablet—which showed an 80% clinical benefit rate at twice-daily dosing versus 40% once-daily—by switching to a lipid-based softgel designed to improve absorption consistency.
Enrollment of both cohorts removes a near-term execution risk and validates the reformulation strategy, but the company remains entirely dependent on Phase I data delivery by year-end and subsequent expansion cohort results to demonstrate whether the new formulation resolves the absorption gap and supports clinical efficacy.
Insights assembled by AI. Editor-reviewed and grounded in tickstock’s coverage and proprietary knowledge graph.
Content is for informational purposes only, not financial advice.
