Ox-1 Programme Achieves Manufacturing Milestone
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TheraCryf plc
("TheraCryf", the "Company" or the "Group")
Ox-1 Addiction Programme Achieves First Manufacturing Milestone
Scale up of drug quantity achieved ahead of schedule
Alderley Park, 3 November 2025 - TheraCryf plc (AIM: TCF), the clinical stage drug development company focussing on brain disorders, provides an update on key activity in its Ox-1 development programme.
· 0.5kg scale-up completed, ahead of schedule
· Manufacturing of 2kg human grade material initiated
· 10kg manufacturing scale-up proceeding to plan
Successful achievement of compound scale-up, from small gram quantities to 0.5kg, is a significant milestone for the Company. This milestone was reached ahead of schedule and with no issues. After formulation to the optimal dosage form, the compound will be used in an in vivo study to identify the 'therapeutic index': this is the range between which the dose is expected to have a therapeutic effect and the highest dose of compound reached before any harmful effects are observed. Data from this study will inform dosing in the key 28-day toxicology studies scheduled to commence in early 2026.
The 28-day toxicology studies will be supplied by the 10kg compound scale-up which is currently proceeding to plan and schedule.
The Company have also now initiated work through its partner, Pharmaron, to manufacture drug product for human use in the Ph1 healthy volunteer study. This process is conducted under special conditions, referred to as GMP (Good Manufacturing Practice), a regulatory standard to ensure safety and quality in order that the product can be given to people. Data from this activity will form part of the regulatory package required for the clinical trial application.
Dr Helen Kuhlman, COO of TheraCryf commented:
"The achievement of this first stage of compound scale-up is testament to the expertise and drive of the TheraCryf team and our colleagues at Pharmaron who continue to deliver excellent progress on our Orexin programme.
"We stated in our previous update that we would inform the market of this key milestone and it is very satisfying to be able to share that we got there ahead of schedule.
"We anticipate updating the market over the coming weeks and months on further substantial progress. This will include completion of the 10kg manufacturing scale-up campaign, further dose range finding studies to enable the initiation of the toxicology studies and the start and finish of the regulatory standard 28-day toxicology studies. We will also provide updates on the GMP manufacture of compound intended for human administration, along with our interactions with appropriate regulatory agencies in preparation for our clinical trial application.
"We remain confident that we are on target to achieve the data required to support a clinical trial submission for this exciting programme according to the plan we have outlined."
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About TheraCryf plc
TheraCryf is the clinical stage drug development company focussing on brain disorders. The Company has a broad clinical and preclinical pipeline in indications including addiction, anxiety, fatigue, narcolepsy, glioblastoma* and neurodevelopmental disorders [*orphan indication].
The Company's strategy is to generate compelling data sets to preclinical and/or clinical proof of concept and partner its clinical programmes with mid-size to large pharma for larger trials and commercialisation. It also has a number of industry partnerships with companies, including Stalicla SA, in neurodevelopmental disorders. The Company has sourced know-how for programmes from companies such as Shire (now Takeda).
TheraCryf has worked with and has ongoing collaborations with major universities and hospitals such as the University of Manchester, La Sapienza (Università di Roma), the Erasmus Medical Centre, Rotterdam, Kings College London and the University of Michigan.
The Company has its headquarters and registered office at Alderley Park, Cheshire. It is quoted on AIM in London and trades under the ticker symbol TCF.
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