Announcement • Aug 08
Solvonis Therapeutics Advances SVN-015 Into Further NIDA-Funded Studies Following Encouraging Initial Screening Solvonis Therapeutics plc announced 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 Addiction Treatment Discovery Program. 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 and serotonin transporter. It is being developed initially as a potential treatment for stimulant use disorder, including cocaine and methamphetamine use disorders. 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. 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, and 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. 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. Announcement • Jun 22
Solvonis Therapeutics Announces Positive Bridging Data Supporting Planned U.S. 505(b)(2) Pathway Towards Phase 2b Clinical Trial of SVN-002 Solvonis Therapeutics plc announced positive pharmacokinetic (PK) data from the preclinical bridging study for its SVN-002 development programme. SVN-002 is Solvonis' proprietary esketamine oral thin-film (OTF) formulation being developed for moderate-to-severe Alcohol Use Disorder (AUD) in the United States. It is designed for supervised, clinic-administered sublingual-buccal dosing. The programme also incorporates a structured alcohol education component, intended for future remote digital access by patients. The programme is being advanced under a planned U.S. Food and Drug Administration (FDA) 505(b)(2) regulatory pathway referencing the FDA-approved intranasal esketamine product, Spravato®. The nonclinical study was designed to assess whether the intended combined sublingual-buccal administration of SVN-002 could generate systemic esketamine exposure supportive of a scientific bridge to the approved intranasal esketamine reference product. At the same nominal dose level, combined sublingual-buccal administration of SVN-002 produced rapid systemic exposure to parent esketamine. Exposure levels for parent esketamine and the key measured metabolites, noresketamine and hydroxynoresketamine, were within the range observed for the intranasal esketamine comparator arm, providing important translational support for the planned scientific bridge. At the December 2024 Type B pre-IND meeting held with the FDA by Awakn Life Sciences, prior to the asset's acquisition by Solvonis, FDA identified systemic exposure to esketamine and relevant metabolite exposure as key considerations for the initial Investigational New Drug (IND) package. Solvonis believes these newly generated data provide important translational support in relation to the FDA-identified exposure considerations and strengthen the planned initial IND package for SVN-002. Following these positive results, Solvonis will seek further FDA feedback on the scope and scale of the remaining nonclinical toxicology work required for the initial IND submission. Subject to FDA feedback and successful completion of this targeted toxicology package, Solvonis plans to submit an IND to support the initiation of a Phase 2b clinical trial of SVN-002 in patients with moderate-to-severe AUD in the United States. AUD represents a major and underserved U.S. market opportunity characterised by limited pharmacological innovation. According to the 2024 U.S. National Survey on Drug Use and Health, approximately 27,900,000 people aged 12 and older in the U.S. had Alcohol Use Disorder in the past year. Solvonis estimates that approximately 15,000,000 U.S. adults fall within the programme's target moderate-to-severe AUD population. Spravato® provides a relevant commercial reference point for supervised, clinic-administered esketamine treatment models. Johnson & Johnson reported worldwide Spravato® sales of approximately USD 1,700 million in 2025 for depression-related indications. Solvonis estimates that SVN-002's target U.S. moderate-to-severe AUD population is approximately five times larger than the estimated U.S. treatment-resistant depression comparator population of approximately 2,800,000 people. The planned 505(b)(2) pathway is central to the capital efficiency of the SVN-002 development strategy. A successful 505(b)(2) route may allow Solvonis to rely, in part, on the FDA's prior findings of safety and/or effectiveness for the approved intranasal esketamine reference product, provided a suitable scientific bridge is established. Solvonis intends to build the SVN-002 package using existing third-party preclinical data, in-licensed Phase 1 clinical data, and targeted SVN-002 bridging and toxicology studies, rather than duplicating a full conventional de novo development package. The Company believes this approach has the potential to reduce development expenditure and support a more capital-efficient route towards Phase 2b. The pharmacokinetic profile observed in this study is very encouraging. Combined sublingual-buccal administration produced rapid systemic exposure to parent esketamine and supports the core rationale for SVN-002 as a transmucosal thin-film product. These results provide important translational evidence for the planned U.S. regulatory pathway and support SVN-002's continued development as a supervised, clinic-administered treatment candidate for AUD. Announcement • May 28
Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026 Solvonis Therapeutics plc, Annual General Meeting, Jun 19, 2026. Location: the offices of orana corporate llp, eccleston yards, 25 eccleston place, sw1w 9nf, london United Kingdom 
