Solvonis Therapeutics PLC (LSE:SVNS) this week shared a business update following its recent acquisition of Awakn Life Sciences, outlining progress across multiple central nervous system (CNS) programs and its licensing strategy.
The company said the deal with Awakn has added clinical-stage assets focused on alcohol use disorder and psychiatry, including a joint venture for a post-traumatic stress disorder (PTSD) program. It also acquired a library of chemical entities now underpinning its AI-driven discovery platform.
CEO Anthony Tennyson told Proactive that the company is targeting high-burden CNS diseases where current standards of care are limited or absent.
Proactive: Anthony, very good to speak to you. The acquisition of Awakn Life Sciences has been called transformational. How has it broadened Solvonis’s pipeline and strengthened its capabilities?
Anthony Tennyson: Stephen, it's good to talk to you and your audience again today. I think let's start by taking a look at what we are seeking to do in Solvonis Therapeutics. What we are seeking to do is to develop a platform biotech focused on high-burden central nervous system diseases such as CNS diseases. And by high burden, what I mean is diseases with significant, addressable markets and very poor or non-existent current standards of care.
So, our acquisition of Awakn really enhanced our competencies and capabilities across two of the three core pillars that we are seeking to innovate in. We're seeking to develop innovative treatments for diseases in addiction, psychiatry, and urology.
With the acquisition of Awakn, we were able to acquire linked clinical-stage programs within addiction for alcohol use disorder and then acquire the full joint venture program that we were undertaking with Awakn in psychiatry for post-traumatic stress disorder.
In addition to that, we also acquired a catalogue of novel chemical entities, on which we have established our AI-driven drug discovery platform, which we believe shows strong promise in other addictions and psychiatry indications. It will enable us to step into neurology, enabling us to establish a strong platform across addiction, psychiatry, and urology within the central nervous system space.
Proactive: Can you update investors on progress with your lead programs, particularly SVN-001 in alcohol use disorder and also SVN-002 in the US?
Anthony Tennyson: Happy to do so. As I mentioned, we acquired late clinical-stage R&D programs for alcohol use disorder from Awakn. That lead program, we now call SVN-001. It is a Phase 3 program for severe alcohol use disorder targeting the UK and EU markets.
There are about 13 million people in the UK and EU who suffer with severe alcohol use disorder, and the current standard of care is very poor. Seventy-five percent of people relapse within 12 months after treatment. We're really excited with the progress of that program, which is being executed in a joint venture with the University of Exeter and the UK Department of Health.
Phase 3 recruitment started in July 2024 and is proceeding as planned. We expect recruitment to complete in late 2026 or early 2027, with a data readout from the trial in late 2027 or early 2028.
Everything we're doing in that program—and in our business model overall—is to build and out-license to large pharmaceutical companies. We're currently in discussions with a number of pharmaceutical companies to out-license SVN-001 and will continue to keep your audience updated as we make progress.
Specifically for SVN-002, this is a different program targeting the much larger and more valuable US alcohol use disorder treatment market. We are repurposing J&J’s SPRAVATO, which is a blockbuster medicine used for the treatment of depression.
We had a very positive meeting with the FDA last year. They agreed that we can repurpose SPRAVATO once we establish a scientific bridge. That’s really important because if we succeed, it allows us to avoid significant costs associated with preclinical and Phase 1 studies.
We're working to establish that scientific bridge with WuXi and hope to submit an application to the FDA next year for a Phase 2b program using repurposed ketamine to treat moderate to severe alcohol use disorder in the US.
Proactive: You’ve highlighted the aim of becoming a partner of choice for large pharma in CNS disorders. What steps are you taking to achieve this?
Anthony Tennyson: Our business model is about developing assets, progressing them efficiently through R&D stages, and then licensing them to larger pharmaceutical companies. That’s not very innovative—it’s the standard model for most biotech companies.
As I mentioned, we’re currently in discussions with four pharma companies to out-license our lead program. For the SVN-002 program, our aim is that, once we’ve successfully completed the Phase 2b program in the US, we will seek licensing partners.
To articulate the value at stake here, a peer company called Gilgamesh out-licensed their lead program for a total price of $1.20 billion. What they are doing is not too dissimilar to what we are doing with some of our R&D programs. So, we believe there's significant value creation potential in our out-licensing model.
Proactive: What are the key milestones investors can expect for the rest of 2025, Anthony?
Anthony Tennyson: Great question. For the rest of 2025, we expect progress on the licensing of our lead program SVN-001, completion of the scientific bridge with WuXi for SVN-002, and declaration of a lead candidate for the SVN-SDN14 program, which is targeting post-traumatic stress disorder.
We’re also working on several initiatives that we believe will deepen our pipeline within our addiction and psychiatry pillars and potentially enable us to branch further into our neurology pillar. There’s a lot of activity going on, and we expect significant news flow in the coming period.
Proactive: Anthony, you'll keep us updated with your progress on that.