REG - Solvonis Therapeutic - Translational Bridging Studies

Solvonis TherapeuticsAnnouncement

Tue 07:00

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RNS Number : 9498R  Solvonis Therapeutics PLC  22 July 2025

22 July 2025

Solvonis Therapeutics plc

("Solvonis" or the "Company")

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."

 

Enquiries:

Solvonis Therapeutics plc

Anthony Tennyson, CEO & Executive Director

anthony@solvonis.com

Allenby Capital Limited (Financial Adviser and Joint Broker)

Nick Naylor / Nick Athanas / Ashur Joseph (Corporate Finance)

Guy McDougall (Sales & Corporate Broking)

+44 (0) 20 3328 5656

Singer Capital Markets (Joint Broker)

Phil Davies

+44 (0) 20 7496 3000

About Solvonis Therapeutics plc

Solvonis Therapeutics plc (LSE: SVNS) is a clinical-stage biopharmaceutical
company developing novel medicines for addiction and mental health 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 targeting high-burden neuropsychiatric conditions with
significant unmet need.

The Company's lead programmes address Alcohol Use Disorder ("AUD") and
Post-Traumatic Stress Disorder ("PTSD"), conditions affecting over 80 million
people across the UK, US, and EU4. Its lead asset, SVN-001, is currently in
Phase 3 for severe AUD in Europe and the UK. SVN-002 is preparing for a Phase
2b trial in the US targeting moderate to severe AUD. Solvonis also has a
preclinical PTSD programme leveraging novel serotonin-dopamine modulators
designed to enhance pro-social behaviour and long-term outcomes.

In addition, Solvonis is advancing an AI-supported discovery platform built on
a proprietary central nervous system compound library, with initial focus on
depression and stimulant use disorders. This initiative expands the Company's
R&D pipeline into earlier-stage innovation while maintaining strategic
focus on comorbid and underserved neuropsychiatric conditions.

With a capital-efficient model, dual development strategy, and near-term
partnering opportunities, Solvonis is positioned to generate value through
innovation in neuropsychiatry.

 

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.

 

 

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