Coiled Therapeutics (AIM:COIL) (AIM: COIL), the clinical-stage precision oncology developer, said the first patient in the United States has been dosed with an optimised lipid-based oral formulation of AO-252.
Initial post-dose safety monitoring identified no treatment-related adverse findings.
AO-252 is the company's brain-penetrant small molecule inhibitor of TACC3, currently in a Phase I trial in the US for advanced solid tumours.
The new softgel formulation delivers the drug in a pre-dissolved system, aiming for more consistent, dose-proportional absorption after the earlier tablet version showed dose-dependent absorption limitations.
That tablet formulation, dosed twice daily, produced an 80% clinical benefit rate in five patients with an average of five prior treatment lines, against 40% in a once-daily cohort of five patients, as the company reported on 7 July.
The directors believe the improved pharmacokinetic profile could support testing at higher doses while preserving that clinical activity.
The new formulation is intended to underpin planned dose-expansion cohorts of up to 30 patients in ovarian and prostate cancer, both indications the company says have drawn commercial interest from large pharmaceutical companies.
"By optimising systemic drug exposure, we aim to build on the 80% Clinical Benefit Rate we have already demonstrated in our BID cohort," said chief executive Sridhar Vempati.
Coiled Therapeutics expects initial safety and pharmacokinetic data from the new formulation in the fourth quarter, alongside the start of the targeted dose-expansion cohorts.
News Intelligence what this means for the company
Coiled dosed the first US patient with a reformulated softgel version of AO-252 designed to overcome absorption limitations of the earlier tablet formulation, with no treatment-related adverse events reported on initial safety monitoring. The new formulation targets dose-proportional absorption to enable higher-dose testing while preserving the 80% clinical benefit rate observed in the twice-daily tablet cohort, underpinning planned expansion into ovarian and prostate cancer with up to 30 patients.
The formulation switch addresses a concrete pharmacokinetic constraint—dose-dependent absorption that capped exposure in the tablet version—and removes a technical barrier to dose escalation. Initial safety data from the softgel and start of dose-expansion cohorts are expected in Q4 2026, providing near-term clinical readouts on whether the improved exposure translates to efficacy gains in larger, indication-specific patient populations.
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