REG - Theracryf PLC - Ox-1 Patent Grant & Development Programme Update

TheracryfAnnouncement

04/09/2025 07:00

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RNS Number : 9335X  Theracryf PLC  04 September 2025

 

TheraCryf plc

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

 

Ox-1 Patent Grant and Positive Development Programme Update

 

Alderley Park, 4 September 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.

 

Korean Patent Grant for Ox-1

The Company received a notification of a Decision to Grant a Patent for its
Orexin-1R antagonist in addiction from the Korean Intellectual Property Office
(KIPO). This grant complements TheraCryf's already broad coverage across the
major commercial markets including US, EU and other Asian territories. The
patent cover for this programme is composition of matter (CoM), the strongest
form of patent cover available.

 

Additionally, the Company is pleased to report on significant development
progress on the Orexin programme. The manufacturing campaign continues
on-track and to-plan to produce multi kilogram quantities.  An optimal
formulation of the lead compound has recently been identified and, based on
new data, the non-rodent species has been selected for the 28-day toxicity
studies that will commence in early 2026.

 

Formulation

A number of potential Amorphous Solid Dispersions (ASD) of the lead compound
were screened in vitro and the optimal formulation taken forward into an in
vivo pharmacokinetics (PK) study. The chosen formulation has optimal features
allowing for the utilisation of a straightforward drug-in-capsule drug
delivery approach for first-in-human studies, and provides enhanced oral
absorption and exposure, meaning less product will be required to achieve the
blood levels needed for potential effectiveness.

 

Second preclinical species selection

The lead compound was tested in vivo in an alternative non-rodent species for
the first time, where it exhibited highly favourable handling properties. This
has enabled the confirmation of this species, which has comparability with
human metabolism and is accepted by major regulatory agencies, for the 28-day
repeated dose toxicity studies, data from which will form an essential element
of the clinical trial application next year.

 

Dr Helen Kuhlman, COO of TheraCryf commented:

"Our Intellectual Property cover for all major territories for our lead
programme in addiction is very nearly complete. We are also pleased that the
key pre-clinical activities needed in our Ox-1 development programme before
first-in-human trials can be initiated are progressing on-time and to-plan.

 

"We now have a tractable formulation for both animal and human use and our
second toxicology species, as required by regulatory authorities, has been
confirmed by new data showing appropriate handling of our Ox-1 lead compound
in blood following oral administration.

"We anticipate updating the market over the coming weeks and months on
further substantial progress. This will include completion of the 0.5 and
10kg scale manufacturing campaigns, 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 manufacture of bulk and capsule material to a standard
acceptable for human administration, along with our interactions with
appropriate regulatory agencies in preparation for our clinical trial
application.

"In short, with this substantial recent progress 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."

 

-Ends-

Enquiries

 TheraCryf plc                                       +44 (0)1625 315 090

 Dr Huw Jones, CEO                                   enquiries@theracryf.com

 Toni Hänninen, CFO

 Dr Helen Kuhlman, COO

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

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

 James Pope / Andy Thacker

 Vigo Consulting                                     +44 (0)20 7390 0230

 Rozi Morris                                         theracryf@vigoconsulting.com

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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