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(Sharecast News) - Theracryf said on Thursday that initial toxicology data from its lead Ox-1 blocker addiction programme showed the drug was well tolerated at very high doses, as clinical trial-enabling work continued ahead of plan.
The AIM-traded biotech, which is developing treatments for addiction and other neuropsychiatric disorders, said dosing of the first toxicology species was completed in early May.
Initial analysis showed the Ox-1 blocker was well tolerated at doses up to 100 times the expected requirement for human therapeutic use, well above the tenfold safety margin required under FDA guidelines.
Theracryf said the programme remained on track to deliver the data needed to support an application for Phase 1 human clinical trials before the end of 2026, which it described as a major value inflection point.
The company said the clinic-enabling programme, fully funded in May 2025, had focused on drug manufacturing improvements and scale-up, development of analytical methods for animal and human clinical samples, and toxicology studies in two species.
Manufacturing had now been successfully scaled up, with more than two kilograms of drug produced for potential use in human trials.
Theracryf said improvements to the manufacturing process had led to a patent application which, if granted, would extend commercial protection to 2046 and increase the potential value of future licensing deals.
All remaining activities were expected to complete on schedule by the end of the third quarter, when an application for human Phase 1 trials could be submitted.
The Ox-1 blocker was being developed for substance use disorders, a market Theracryf said was already worth more than $70bn a year.
The company said preclinical data had shown potential class-leading performance, including proof of efficacy in a rodent model of binge eating disorder.
Chief executive officer Huw Jones said the team had delivered the preclinical development programme "on budget and ahead of schedule with such outstanding results".
"Our Ox-1 blocker continues to demonstrate class leading potential and is now clearing the final toxicology hurdles to allow us to apply for a Phase 1 study in healthy human volunteers," he said.
Jones added that neuroscience assets at Phase 1 clinical stage attracted upfront payments in the range of $26m to $49m, and said Theracryf had recently rejected an approach that it believed undervalued the assets in its pipeline.
"We continue to work proactively with other partners including following up on other incoming approaches with a view to maximising value for shareholders through a licensing deal," he said.
Chairman Alastair Smith said Theracryf was approaching "a very exciting inflection point" as its lead programme moved towards human trials, adding that addiction and the broader neuropsychiatric space remained a current focus for large pharmaceutical companies.
At 1338 BST, shares in Theracryf were up 10.5% at 0.24p.
Reporting by Josh White for Sharecast.com.
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