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(Sharecast News) - TheraCryf said on Monday that its lead Ox-1 receptor antagonist programme for addiction had advanced to final toxicology studies, keeping the biotech group on track to begin human clinical trials by the end of 2026.
The AIM-traded company confirmed completion of preclinical dose range finding studies, a key step in determining appropriate dosing for pivotal toxicology work.
It said the Ox-1 blocker was reported to be well tolerated at doses of up to one gram per kilogram of body weight, the highest level permitted by regulators in such studies.
The results supported progression into 28-day toxicology studies, the final major preclinical requirement before submission for regulatory approval to commence a first-in-human phase one clinical trial.
TheraCryf said the studies would begin imminently, with final reporting expected in the third quarter of 2026.
It said findings from the dose studies were consistent with data from other Ox-1 and dual Ox-1/2 antagonists that had achieved full marketing approval, reinforcing confidence in the programme's safety profile.
"We continue to deliver a potentially class leading asset on target for clinic readiness in the fourth quarter of this year, exactly in line with the plan outlined at the start of this project," said chief executive Dr Huw Jones.
"The substance use disorder market is already worth over $42bn growing to over $71bn over the next seven years.
"These conditions cause more deaths than road accidents and substance abusers lose over 20 years of life compared to non-abusers."
Jones said the company expected its Ox-1 programme to attract commercial interest from larger pharmaceutical companies, noting that licensing opportunities at the appropriate stage of development could generate significant returns.
At 1449 GMT, shares in TheraCryf were up 0.39% at 0.21p.
Reporting by Josh White for Sharecast.com.
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