REG - Theracryf PLC - Ox-1 Addiction Programme Update

TheracryfAnnouncement

26/01/2026 07:00

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RNS Number : 2133Q  Theracryf PLC  26 January 2026

 

26 January 2026

TheraCryf plc

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

 

Ox-1 Addiction Programme Update

Final major market patent granted in Canada

Progress on IND enabling preclinical safety studies

Best-in-class Ox-1 asset continues to be de-risked ahead of clinical readiness

 

TheraCryf plc (AIM: TCF), the biotech company developing new medicines for
addiction and other disorders of the brain, is pleased to announce that it has
received a Notice of Allowance from the Canadian Patent Office for its
Orexin-1 (Ox-1) addiction programme, alongside a positive update on ongoing
preclinical development.

 

The Canadian patent represents the final major market to grant for this
intellectual property, completing broad protection across the US, Europe,
Canada and key Asian territories. The patent provides Composition of Matter,
the strongest form of patent cover available, conferring long-term exclusivity
and significantly strengthening the commercial and partnering proposition for
the programme.

 

The Group also reports continued progress on its Maximum Tolerated Dose (MTD)
and Dose Range Finding (DRF) studies, which commenced earlier this month. The
MTD have now been successfully completed, with two species dosed up to the
regulatory maximum, 1g/kg of the orexin-1 blocker, with no adverse clinical
observations reported. This favourable outcome further de-risks the programme
and enables progression into repeat-dose DRF studies, the results of which
will inform the dosing for the planned 28-day regulatory toxicity studies
scheduled in Q1 and Q2 2026, depending on species.  This is a near final step
on the path to IND/CTA readiness targeted for 2026.

 

Ox-1, TheraCryf's lead programme, is a novel, best-in-class orexin-1 blocker,
being developed as a potential treatment for addiction, including alcohol and
other substance use disorders. The programme demonstrates class-leading
selectivity and high receptor occupancy, characteristics which are expected to
translate into improved tolerability and efficacy.  Blocking the orexin-1
pathway has been shown to reduce aberrant substance-seeking behaviour in
animal models, and the orexin pathway has attracted strong interest in the
pharmaceutical sector.

 

Addiction represents a large and growing global market, with substantial unmet
medical need and significant human, social and economic impact, making it an
attractive indication for development and commercialisation.

 

Dr Helen Kuhlman, Chief Operating Officer of TheraCryf, commented:

 

"Securing the Canadian patent completes coverage across all major commercial
markets for our Ox-1 programme and strengthens its long-term value. Completion
of our maximum tolerated dose studies further de-risks our best-in-class lead
asset as we progress towards clinical readiness.

 

We remain well positioned to generate key value inflection data and advance
Ox-1 towards partnering opportunities."

 

-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 disorders of the brain, 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 is
heavily de-risked, demonstrates superior selectivity and high receptor
occupancy, and is fully funded through to clinical readiness, with regulatory
submissions 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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