Solvonis Therapeutics plc (LSE: SVNS), a late clinical-stage biopharmaceutical company developing novel small-molecule therapeutics for high-burden central nervous system (“CNS”) disorders, is pleased to announce encouraging results from the initial in vitro cardiac ion-channel and broader off-target screening of SVN-015 under the U.S. National Institute on Drug Abuse’s (“NIDA”) Addiction Treatment Discovery Program (“ATDP”). The Company previously announced SVN-015’s acceptance into the ATDP in December 2025.
Following review of the initial screening results, NIDA has confirmed that SVN-015 will advance into further evaluation under the ATDP. This is expected to include confirmatory transporter studies and in vivo studies to characterise the onset and duration of its pharmacological activity.
SVN-015 is a proprietary discovery-stage small molecule designed to modulate key monoamine transporters, including the dopamine transporter (“DAT”) and serotonin transporter (“SERT”). It is being developed initially as a potential treatment for stimulant use disorder, including cocaine and methamphetamine use disorders.
Encouraging Initial Screening Results
The initial NIDA evaluation was designed to identify potential cardiac ion-channel and broader off-target liabilities before SVN-015 progressed into more extensive preclinical pharmacological studies.
SVN-015 completed the initial cardiac ion-channel screening and demonstrated an encouraging broader off-target profile. The results were sufficiently encouraging for NIDA to progress the compound into further evaluation.
On the cardiac ion-channel measures assessed to date, SVN-015 demonstrated a more favourable profile than GBR-12909, an earlier dopamine transporter inhibitor evaluated by NIDA as a potential treatment for cocaine dependence and known to interact with several cardiac ion channels.
These preliminary preclinical findings do not establish the safety of SVN-015 in humans or whole animals. Further safety pharmacology, toxicology and clinical evaluation will be required as the programme progresses.
Advancement into Further Preclinical Evaluation
The next stage of the NIDA programme is expected to further characterise SVN-015’s intended transporter pharmacology, off-target profile and activity in vivo.
The planned work is expected to include:
· in vivo mouse locomotor-activity time-course study to characterise the onset and duration of SVN-015’s pharmacological effects
· confirmatory DAT binding and functional studies;
· follow-up assessment of activity at the 5-HT2B receptor.
These studies will be funded and undertaken through NIDA’s preclinical ATDP. This support provides Solvonis with access to NIDA-funded specialist research capabilities rather than a grant payment to the Company. Solvonis retains ownership of SVN-015 and its associated intellectual property.
Successful completion of this stage would provide Solvonis with an important preclinical data package to inform the compound’s future development strategy and could support applications for additional non-dilutive NIH or NIDA development funding.
SVN-015 and the Unmet Need in Stimulant Use Disorder
There is currently no FDA-approved medication for stimulant use disorder, including cocaine and methamphetamine use disorders. Existing treatment is primarily based on behavioural interventions, leaving a significant unmet need for effective pharmacological treatment options.
SVN-015 emerged from Solvonis’ proprietary, AI-enabled CNS discovery programme. Composition-of-matter patent applications have been filed to protect the compound and related intellectual property.
Anthony Tennyson, Chief Executive Officer of Solvonis Therapeutics, said: “This is an important development milestone for SVN-015. The compound has completed NIDA’s initial cardiac ion-channel and broader off-target screening, demonstrated an encouraging initial profile and will now advance into further NIDA-funded evaluation.
“Particularly encouraging is SVN-015’s cardiac ion-channel profile relative to GBR-12909. These early results suggest that SVN-015 may have the potential to deliver the intended transporter pharmacology while avoiding some of the cardiac ion-channel liabilities associated with previous compounds in this area.
“NIDA’s decision to progress SVN-015 provides important external validation of the case for its further evaluation and gives Solvonis access to specialist, non-dilutive preclinical development capabilities. The next stage should tell us considerably more about the compound’s transporter pharmacology, selectivity and activity in vivo.”
Professor David Nutt, Chief Scientific Officer of Solvonis Therapeutics, added: “These are highly promising early findings. Cardiac ion-channel activity has been an important challenge in the development of previous dopamine transporter inhibitors. Across the cardiac ion-channel assays completed to date, SVN-015’s profile appears materially more favourable than that of GBR-12909.
“The next stage of NIDA’s evaluation will be important in confirming the compound’s transporter pharmacology, further characterising its off-target profile and establishing the onset and duration of its pharmacological effects in vivo.
“There remains an urgent need for effective pharmacological treatments for cocaine and methamphetamine use disorders, and we are very pleased that SVN-015 is progressing into this next stage of evaluation.”
The content of this press release is solely the responsibility of Solvonis Therapeutics and does not necessarily represent the official views of the U.S. National Institutes of Health or the U.S. National Institute on Drug Abuse.
Enquiries
Solvonis Therapeutics plc
Anthony Tennyson, CEO & Executive Director
info@solvonis.com
Singer Capital Markets (Broker)
Russell Cook
+44 (0) 20 7496 3000
About Solvonis Therapeutics plc
Solvonis Therapeutics plc (LSE: SVNS) is a late clinical-stage biopharmaceutical company developing 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 discovery-stage compounds across addiction and psychiatry.
The Company’s lead programmes target Alcohol Use Disorder (“AUD”) and Post-Traumatic Stress Disorder (“PTSD”), with additional development and discovery work supporting expansion into further addiction and psychiatric indications, including stimulant use disorder and depressive disorders.
Its lead asset, SVN-001, is currently in Phase 3 for severe AUD in the UK, while SVN-002 is being advanced towards a planned Phase 2b trial in the United States targeting moderate-to-severe AUD. The Company’s PTSD discovery programme has identified SVN-114 as a lead compound, emerging from a proprietary compound series designed to modulate key brain-signalling systems associated with emotional processing and social behaviour.
SVN-015 is the Company’s proprietary discovery-stage candidate targeting stimulant use disorder. Following encouraging initial cardiac ion-channel and broader off-target screening results, it is advancing into further preclinical evaluation under NIDA’s Addiction Treatment Discovery Program.
In parallel, Solvonis is advancing proprietary CNS discovery programmes supported by a dedicated compound library and AI-enabled discovery capabilities to identify new small-molecule modulators of key neurotransmitter systems.
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