REG - Solvonis Therapeutic - Update on AWKN-SDN-14 programme

Solvonis TherapeuticsAnnouncement

18/03/2025 07:00

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RNS Number : 0119B  Solvonis Therapeutics PLC  18 March 2025

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 18 March 2025

Solvonis Therapeutics plc

("Solvonis" or the "Company")

Update on AWKN-SDN-14 programme, including the appointment of Evotec SE
("Evotec") to progress preclinical testing

 

Solvonis Therapeutics plc (LSE: SVNS), an innovative biotechnology company
co-developing therapeutics for mental health disorders, provides an update on
its collaboration with Awakn Life Sciences Corp. ("Awakn").  The
collaboration is focused on developing next-generation treatments for
trauma-related mental health disorders, such as Post-Traumatic Stress Disorder
("PTSD"), which affects approximately 13 million adults in the U.S. and which
the Company estimates affects 20 million in the US, the UK, and other key EU
markets.

AWKN-SDN-14 programme overview

The AWKN-SDN-14 programme (the "Programme") is dedicated to developing a novel
pro-social drug candidate, with the potential for an improved safety profile
compared to existing investigational PTSD treatments. By enhancing trust,
empathy, and social bonding, being critical elements in PTSD therapy,
 AWKN-SDN-14 aims to help individuals rebuild relationships, overcome
isolation and engage more effectively in treatment.

The drug candidate is designed to modulate neurotransmitter activity,
specifically enhancing the release of Serotonin ("SERT"), Dopamine ("DAT"),
and Noradrenaline ("NET").

The key initial stages of the Programme include:

1.    Preclinical drug discovery

2.    Intellectual property protection

3.    Synthesis of development candidates

4.    In-vitro screening for SERT, DAT, and NET re-absorption inhibition

5.    In-vitro screening for SERT, DAT, and NET release

6.    Preclinical animal testing

7.    Lead candidate selection

Progress and updates

1.     Preclinical drug discovery.

This phase was successfully completed by Prof. David Nutt prior to the
execution of the collaboration agreement between Solvonis and Awakn, details
of which were announced by the Company on 18 July 2024.

2.     Intellectual property ("IP") protection.

Awakn has protected relevant IP through two patents filed with the World
Intellectual Property Organization ("WIPO") in Q2 2022 and Q3 2024.

3.     Synthesis of development candidates.

The synthesis of six development candidates was originally contracted to
Charnwood Discovery ("Charnwood"). However, following Charnwood's
administration in Q4 2024 (the "Administration") work was temporarily
disrupted. At the time of the Administration, 50% of the synthesis had been
completed, with three development candidates successfully synthesised.

Awakn has now contracted Concept Life Sciences ("Concept"), the acquirer of
Charnwood, to complete the remaining synthesis. Following a brief pause for
knowledge transfer, work has now resumed, and completion is expected by
end-May 2025.

4.     In-vitro screening for re-absorption inhibition (SERT, DAT, NET).

Partial completion has been achieved by Eurofins Discovery ("Eurofins"), with
testing performed on the three development candidates synthesised by
Charnwood.

5.     In-vitro screening for SERT, DAT, and NET release - Evotec
appointed by Awakn to lead key preclinical testing.

To ensure the highest standard of preclinical validation, Awakn has appointed
Evotec, a globally recognised leader in drug discovery and development, to
conduct in-vitro screening for SERT, DAT, and NET release activity.

Evotec brings world-class expertise in:

·    Neurotransmitter pharmacology

·    High-throughput screening

·    Precision drug discovery

Evotec's analysis will provide critical insights into the candidates' ability
to modulate neurotransmitter release, a key mechanism underpinning
AWKN-SDN-14's therapeutic potential.

This in-vitro testing phase, which builds on the positive animal testing
results, is expected to be completed by the end of July 2025, aligning with
the revised Programme timeline.

6.     Preclinical animal testing.

Awakn has previously announced successful preclinical animal testing results
for one of the three synthesised candidates. The study demonstrated promising
early signs of efficacy, supporting the potential of AWKN-SDN-14 as a
next-generation PTSD treatment. These results provide a strong scientific
foundation for the next phase of testing.

7.    Lead candidate selection.

Following the completion of all preclinical screening, the Company expects to
select a lead candidate by the end of Q3 2025, with a view to complete the
sixth and final phase of the Programme.

Conclusion

Solvonis and Awakn remain fully committed to advancing the Programme and are
encouraged by the progress achieved to date. With Concept resuming synthesis
and Evotec engaged for key preclinical testing, the Programme remains on track
to meet its revised milestones.

Further updates will be provided as the Programme progresses.

 

Enquiries:

Solvonis Therapeutics plc, Anthony Tennyson, CEO & Executive Director,
Email: anthony@solvonis.com

Allenby Capital (Financial Adviser and Broker) +44 (0) 20 3328 5656

Nick Naylor / Nick Athanas / Ashur Joseph (Corporate Finance) | Guy McDougall
(Sales)

 

About Solvonis Therapeutics plc

Solvonis Therapeutics plc is an innovative biotechnology company focused on
developing intellectual property related to the treatment of mental health and
substance use disorders, and co-developing therapeutics for mental health
disorders. Solvonis' mission is to improve outcomes for individuals suffering
from mental health disorders, with an initial focus on trauma-related mental
health conditions, such as PTSD. PTSD affected approximately 13 million adults
in the U.S. in 2020, with the Company estimating a current affected population
of 20 million across the U.S., UK, and key EU markets.

www.solvonis.com (http://www.solvonis.com) | LinkedIn
(http://www.linkedin.com/company/solvonis) | X (formerly Twitter)
(https://x.com/SolvonisTx)

 

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