REG - Solvonis Therapeutic - SVN-015 accepted into US NIDA funded programme

Solvonis TherapeuticsAnnouncement

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RNS Number : 9389J  Solvonis Therapeutics PLC  03 December 2025

Solvonis Therapeutics plc

("Solvonis" or the "Company")

 

Solvonis' Novel Compound SVN-015 Accepted into US NIDA-Funded Addiction
Treatment Discovery Program for Methamphetamine and Cocaine Addiction

 

Solvonis Therapeutics plc (LSE: SVNS), an emerging biopharmaceutical company
developing novel medicines for high-burden central nervous system (CNS)
disorders, announces that its novel AI-discovered compound, SVN-015, targeting
methamphetamine and cocaine use disorders, has been accepted into the US
National Institute on Drug Abuse's ("NIDA") Addiction Treatment Discovery
Program ("ATDP"). Under the programme, NIDA, part of the US National
Institutes of Health ("NIH"), will fund and conduct early preclinical
evaluation of SVN-015.

 

Programme Overview

In the first stage of the programme, NIDA will fund and carry out in vitro
predictive safety studies on SVN-015 to assess potential cardiovascular risks.
These tests are the normal first step in the development of any new medicine.
If the results are supportive, SVN-015 could advance into ATDP efficacy
studies in validated preclinical models of methamphetamine and cocaine
addiction.

 

If the efficacy studies are successful, Solvonis would be well positioned to
compete for a non-dilutive NIH research grant, which can provide up to US$3
million per year for as long as five years. These grants are competitive, but
completion of early preclinical studies would provide the type of safety and
efficacy data needed to support Solvonis' grant application. This creates a
potential pathway from funded NIDA preclinical work through to potential
NIH-funded clinical trials in humans.

 

Strategic Significance

Acceptance of SVN-015 into the ATDP marks an important milestone for Solvonis
as it expands the Company's research in addiction beyond alcohol use disorder
("AUD") into stimulant addictions - specifically methamphetamine and cocaine -
which remain among the most severe psychiatric conditions with no approved
drug treatments.

 

Professor David Nutt, Solvonis Chief Scientific Officer, commented "Being
accepted into NIDA's ATDP for SVN-015 is a major step forward for Solvonis.
ATDP provides a pathway for evaluating the therapeutic potential of SVN-015,
starting with early preclinical testing and, if successful, creating the
opportunity to progress towards NIH clinical development funding through the
UG3/UH3 programme. For methamphetamine and cocaine addiction - where no
approved drug treatments exist - this represents an important advance."

 

Enquiries:

 

 Solvonis Therapeutics plc                                       Via Walbrook
 Anthony Tennyson, CEO & Executive Director

 Singer Capital Markets (Broker)                                 +44 (0) 20 7496 3000
 Phil Davies

 Walbrook PR (PR/IR advisers)  Tel: +44 (0)20 7933 8780 or solvonistherapeutics@walbrookpr.com
                               (mailto:solvonistherapeutics@walbrookpr.com)
 Anna Dunphy                                                     Mob: +44 (0)7876 741 001
 Lianne Applegarth                                               Mob: +44 (0)7584 391 303
 Marcus Ulker                                                    Mob: +44 (0)7867 984 082

 

 

 

 

About SVN-015

SVN-015 is the second compound emerging from Solvonis' AI-enabled drug
discovery programme to progress into external validation, following the
advancement of SVN-SDN-14 for Post-Traumatic Stress Disorder. It is a novel
candidate designed to address stimulant addictions - including methamphetamine
and cocaine dependence - areas with significant unmet need and no currently
approved pharmacological treatments.

 

About NIDA

The US National Institute on Drug Abuse ("NIDA") is a component of the
National Institutes of Health, U.S. Department of Health and Human Services.
NIDA supports most of the world's research on the health aspects of drug use
and addiction. The Institute carries out a large variety of programs to inform
policy, improve practice, and advance addiction science.

 

About Methamphetamine and Cocaine Addiction

Methamphetamine and cocaine addiction remain major public health challenges.
There are no approved pharmacological treatments; patients are managed only
with psychosocial interventions, which deliver limited and inconsistent
outcomes. Both NIDA and the European Monitoring Centre for Drugs and Drug
Addiction ("EMCDDA") identify stimulant use disorders as areas of critical
unmet need, associated with high morbidity, mortality, and significant
societal costs.

 

Epidemiological data highlights the scale of the problem. In the United
States, the National Survey on Drug Use and Health ("SAMHSA 2022") estimates
approximately 2.6 million people meet diagnostic criteria for cocaine or
methamphetamine use disorders. In the EU5, EMCDDA data indicate 0.35-0.5
million patients, predominantly with cocaine dependence. In Japan, national
data suggest around 0.1 million patients, largely with methamphetamine
dependence. Taken together, this represents a combined total of around 3.0-3.2
million individuals across the seven major markets - a large population with
no existing drug treatment options.

 

The content of this press release is solely the responsibility of Solvonis and
does not necessarily represent the official views of the National Institutes
of Health.

 

About Solvonis Therapeutics plc

Solvonis Therapeutics plc (LSE: SVNS) is an emerging biopharmaceutical company
developing novel small-molecule therapeutics for high-burden central nervous
system (CNS) disorders. Headquartered in London and listed on the main market
of the London Stock Exchange, Solvonis is advancing a differentiated pipeline
of repurposed and novel compounds across addiction, psychiatry, and neurology.

 

The Company's lead programmes address Alcohol Use Disorder (AUD) and
Post-Traumatic Stress Disorder (PTSD), with additional discovery work
supporting expansion into broader CNS indications. Its lead asset, SVN-001, is
currently in Phase 3 for severe AUD in the UK, while SVN-002 is preparing for
a Phase 2b trial in the US targeting moderate-to-severe AUD. The preclinical
PTSD programme (SVN-SDN-14) leverages novel serotonin-dopamine modulators
designed to enhance pro-social behaviour and long-term outcomes.

 

In parallel, Solvonis is advancing proprietary CNS discovery programmes built
on a dedicated compound library to identify new small-molecule modulators of
key neurotransmitter systems. This platform enables efficient early-stage
innovation and supports the Company's integrated approach to developing
therapies across its three strategic pillars.

solvonis.com (https://solvonis.com) | LinkedIn
(http://www.linkedin.com/company/solvonis-tx) | X (Twitter)
(https://x.com/Solvonis)

 

 

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