Translational Bridging Studies

SVN‑002: Translational bridging studies initiated to support 505(b)(2) pathway and advance towards Phase 2b trial

Solvonis Therapeutics plc (LSE: SVNS), a clinical-stage biopharmaceutical company developing novel medicines for addiction and mental health disorders, is pleased to announce the initiation of key translational studies to support the advancement of SVN‑002 towards a planned Phase 2b clinical trial in the United States.

SVN‑002 is the Company's differentiated sublingual esketamine oral thin film ("OTF") candidate, being developed as an innovative treatment for moderate-to-severe Alcohol Use Disorder ("AUD") in combination with psychosocial support. The compound is intended to reference Janssen's Spravato® under the US Food and Drug Administration's (the "FDA") 505(b)(2) regulatory pathway, enabling a potentially accelerated and capital-efficient route to registration.

The Company's regulatory strategy for SVN‑002 is informed by a successful pre-Investigational New Drug ("IND") meeting with the FDA which was held in December 2024 by Awakn Life Sciences prior to its acquisition by Solvonis.

As part of this plan, Solvonis has now appointed WuXi AppTec (Hong Kong: 2359.HK; Shanghai: 603259.SH), a leading global research and development and manufacturing services provider, to undertake a targeted pharmacokinetic ("PK") programme designed to generate the scientific bridging data requested by the FDA to establish a clear link to the reference product.

This activity represents a key step in preparing SVN‑002 for the IND submission and Phase 2b trial readiness, in alignment with Solvonis' clinical and regulatory development timelines. The programme is focused on the US AUD market, which remains significantly underserved and affects approximately 29 million individuals.

Professor David Nutt, Chief Scientific Officer of Solvonis, commented: "This translational programme is a critical milestone in delivering on the FDA's feedback which was received during our pre IND meeting. By generating the bridging data required to connect SVN‑002 to the reference product, we are laying the scientific foundation for a streamlined 505(b)(2) development pathway and a clear route into Phase 2b trials in the US. AUD remains a devastating and under-treated condition, and we believe SVN‑002 has the potential to make a meaningful difference for millions of patients."

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec's integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AAA ESG rating from MSCI in 2025 and its open-access platform is enabling around 6,000 customers from over 30 countries to improve the health of those in need - and to realize the vision that "every drug can be made and every disease can be treated.