TheraCryf manufactures over 2kg of Ox-1 receptor antagonist substance

20th Apr 2026 11:56

(Sharecast News) - TheraCryf said on Monday that it has successfully manufactured clinical-grade material for its lead Ox-1 receptor antagonist, marking a key step towards initiating human trials.

The AIM-traded group said 2.57 kilograms of drug substance had been produced to Good Manufacturing Practice standards, making it suitable for use in phase one clinical studies.

It said the batch was completed three weeks ahead of schedule and delivered a higher-than-expected yield, demonstrating the scalability and robustness of the company's manufacturing process.

The milestone would enable TheraCryf to move from preclinical to clinical development without delays linked to further manufacturing, with the material now ready for formulation into the final drug product for administration to trial participants.

"Achieving successful GMP manufacture of human-grade Ox-1 drug substance is an important milestone that further de-risks the programme as we move towards the clinic," said chief executive Dr Huw Jones.

"The fact that the manufacturing process has proven robust and reliable, with good yields, enhances the commercial attractiveness of our Ox-1 antagonist."

"Combined with our recent positive preclinical data and the filing of a new patent, this progress reinforces our confidence in Ox-1 as a potentially best-in-class treatment for addiction, a market that will be worth over $70bn1 by 2035.

"With toxicology studies underway and on schedule, we remain focused on advancing towards first-in-human studies and moving the programme towards accretive partnership opportunities with commercially focused pharmaceutical companies."

TheraCryf said completion of its preclinical package, including results from a 28-day toxicology study, remained on track for the third quarter of 2026, after which it expected to submit for regulatory approval to begin human dosing.

It said the Ox-1 programme was being developed to treat substance use disorders, a market the company said was projected to exceed $70bmn by 2035, with significant unmet demand for effective, non-addictive therapies.

At 1050 BST, shares in TheraCryf were up 1.25% at 0.24p.

Reporting by Josh White for Sharecast.com.

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