Coiled Therapeutics (AIM:COIL, OTCQB:COTXF), the AIM-quoted cancer drug developer, said the first patient in the United States has been dosed with a reworked version of its lead treatment, AO-252, with no treatment-related safety findings in initial monitoring.
The switch is intended to fix an absorption problem that limited how much of the drug reached patients under the previous tablet.
The new formulation is a softgel capsule delivering AO-252 already dissolved in a lipid system, designed to give more consistent absorption that scales predictably with dose.
AO-252 is a first-in-class inhibitor of TACC3, a protein implicated in chromosomally unstable tumours, and is able to cross into the brain.
It is in phase I trials in patients with advanced solid tumours.
The reformulation follows data announced on 7 July showing an 80% clinical benefit rate among five patients dosed twice daily, against 40% in a comparable group dosed once a day.
Those patients had already been through an average of five previous lines of treatment, and tumours shrank in some cases of ovarian and endometrial cancer.
Directors believe the improved absorption profile could allow the drug to be tested at higher doses while building on that activity.
The immediate purpose is to clear the way for expansion cohorts in ovarian and prostate cancer, targeting up to 30 patients by the fourth quarter.
Both indications have drawn commercial interest from large pharmaceutical companies, the company said.
Initial safety and pharmacokinetic data from the new formulation are expected in the same quarter.
Coiled expects those results, if positive, to support continued talks with the drugmakers that have already expressed interest.
Sridhar Vempati, chief executive, said the change strengthened the clinical pathway and kept the company on track with its roadmap for the year.
Brian Orr, a medical oncologist and one of the principal investigators on the study, said the pre-dissolved system gave researchers a stronger platform from which to explore higher doses.
