REG - Theracryf PLC - Ox-1 Programme Advances to Final Toxicology Study

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RNS Number : 5497X  Theracryf PLC  23 March 2026

 

23 March 2026

TheraCryf plc

("TheraCryf", the "Company" or the "Group")

 

Lead Ox-1 Programme Advances to Final Toxicology Studies Before Human Phase 1
Clinical Study

Ox-1 blocker well tolerated at the highest regulatory dose permissible

Programme remains on track for clinic readiness by Q4 2026

 

TheraCryf plc (AIM: TCF), the biotech company developing new medicines for
addiction and other neuropsychiatric disorders, today announces completion of
preclinical dose range finding studies for its lead orexin-1 (Ox-1) receptor
antagonist programme being developed for addiction, a market worth US$42
billion(¹) and an area attracting significant clinical and commercial
interest from large pharmaceutical companies.

 

Dose range finding is an essential step in moving a drug into the clinic that
identifies the doses for the pivotal 28-day toxicology study. TheraCryf's Ox-1
blocker was well tolerated at doses up to 1g per 1kg of body weight, the
highest that is permissible by regulators in such a study. Findings from this
study are consistent with data reported for other Ox-1 and dual Ox-1/2
antagonists that have achieved full marketing approval.

 

Based on these results, doses have been selected for the pivotal 28-day
toxicology studies, the final major pre-clinical studies required for
submission for regulatory approval for the first in human clinical study.
These studies will commence imminently, with final reporting on schedule in Q3
2026.

 

Dr Huw Jones, Chief Executive Officer of TheraCryf, commented:

 

"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. The substance use disorder market is
already worth over US$42 billion growing to over US$71 billion(¹) 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(2). The licensing market to
large pharma for such treatments is considerable, generating substantial
returns to originating companies at the right stage of development.  With a
class leading profile, we anticipate generating significant commercial
interest in TheraCryf's Ox-1 asset."

 

1.     Substance Use Disorder Treatment Market Size and Share Forecast
Outlook 2025 to 2035. Future Market Insights Inc, November 2025

 https://www.futuremarketinsights.com/reports/substance-use-disorder-treatment-market
(https://www.futuremarketinsights.com/reports/substance-use-disorder-treatment-market)

 

2.     Gov.uk and Chan et al Lancet 2023

https://www.gov.uk/government/statistics/substance-misuse-treatment-for-adults-statistics-2023-to-2024/adult-substance-misuse-treatment-statistics-2023-to-2024-report
(https://www.gov.uk/government/statistics/substance-misuse-treatment-for-adults-statistics-2023-to-2024/adult-substance-misuse-treatment-statistics-2023-to-2024-report)

https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(25)00174-4/fulltext#:~:text=Variations%20in%20estimates%20of%20alcohol,impact%20policies%20must%20be%20intensified
(https://www.thelancet.com/journals/lanpub/article/PIIS2468-2667(25)00174-4/fulltext#:~:text=Variations%20in%20estimates%20of%20alcohol,impact%20policies%20must%20be%20intensified)

 

-Ends-

 

Enquiries

 

 TheraCryf plc                                       +44 (0)1625 315 090

 Dr Huw Jones, CEO                                   enquiries@theracryf.com (mailto:enquiries@theracryf.com)

 Toni Hänninen, CFO

 Dr Helen Kuhlman, COO

 Singer Capital Markets (NOMAD & Joint Broker)       +44 (0)20 7496 3000
 Phil Davies / Patrick Weaver

 Turner Pope Investments (Joint Broker)              +44 (0)20 3657 0050

 Guy McDougall / Andy Thacker

 Northstar Communications (Investor Relations)       +44 (0)113 730 3896

 Sarah Hollins                                       sarah@northstarcommunications.co.uk
                           (mailto:sarah@northstarcommunications.co.uk)

 

About TheraCryf

 

TheraCryf plc is a biotechnology company developing new medicines for
addiction and other neuropsychiatric disorders, areas of significant unmet
medical need within central nervous system (CNS) disorders.

 

The Group's lead programme is a novel, best-in-class orexin-1 receptor
antagonist being developed as a potential treatment for addiction, including
binge eating, alcohol and other substance use disorders.

The programme has already been heavily de-risked for both safety/tolerability
and efficacy in previous testing and is fully funded through final
pre-clinical trials to clinical readiness, with regulatory submissions for
first in man studies targeted for 2026.

 

TheraCryf also has a dopamine transporter (DAT) modulator programme addressing
fatigue of brain origin, including fatigue associated with multiple sclerosis,
chemotherapy and narcolepsy. The Group also has a legacy, grant-funded,
oncology programme in glioblastoma with SFX-01.

 

The Group operates a capital-light, virtual development model advancing
programmes to early clinical or proof-of-concept stage before partnering with
larger pharmaceutical or biotechnology companies.

TheraCryf's headquarters and registered office are at Alderley Park, Cheshire.

 

For further information, visit: https://theracryf.com (https://theracryf.com)

 

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