Solvonis Therapeutics PLC (LSE:SVNS, OTC:SLVNF) CEO, Anthony Tennyson, talked with Proactive about positive bridging pharmacokinetic (PK) data from the company's SVN-002 programme and what the results mean for its development strategy in alcohol use disorder.
Tennyson explained that Solvonis is advancing SVN-002 towards a planned Phase 2b clinical trial for moderate to severe alcohol use disorder in the United States. The programme is based on repurposing Johnson & Johnson (NYSE:JNJ)'s approved esketamine treatment, Spravato, using a 505(b)(2) regulatory pathway that could allow the company to leverage existing data while pursuing a new indication.
The company reported that preclinical PK studies demonstrated comparable exposure levels of esketamine and its major metabolites when delivered via sublingual and buccal administration compared with intranasal delivery. According to Tennyson, these findings represent an important step in establishing the scientific bridge required by the FDA.
Discussing the significance of the results, Tennyson said: "We've established that Esketamine delivered sublingually and buccally delivers the same exposure as Esketamine delivered intranasally."
He also highlighted the commercial opportunity, noting that the alcohol use disorder treatment market in the US is significantly larger than the treatment-resistant depression market currently served by Spravato. Solvonis estimates that moderate to severe alcohol use disorder affects approximately 15 million American adults.
Tennyson said the data could help support a narrower toxicology package and potentially accelerate the programme's development timeline while maintaining a capital-efficient approach. The next steps include engaging with the FDA to discuss toxicology requirements before submitting an Investigational New Drug (IND) application seeking approval for a planned phase IIb trial.
Proactive: Anthony, good to speak with you. You've announced positive bridging data for SVN-002. What exactly has the company reported today?
Anthony Tennyson: What we reported is positive progress in advancing our SVN-002 programme towards our ultimate goal, which is a Phase 2b clinical trial for moderate to severe alcohol use disorder in the US. We're looking to repurpose J&J's proven intranasal esketamine treatment for depression into a treatment for moderate to severe alcohol use disorder.
We previously met with the FDA and discussed this approach. The FDA advised that it was supportive of a 505(b)(2) pathway into J&J's Spravato, which is a capital-efficient route to repurpose an approved medicine for a new indication.
Importantly, the FDA indicated that once the scientific bridge was established, no further human data would be required before proceeding into Phase 2b. We have now completed the first part of establishing that bridge by assessing the pharmacokinetics of esketamine delivered sublingually and buccally compared with intranasally.
We established that esketamine delivered sublingually and buccally provides the same exposure as intranasal delivery, and the same applies to its major metabolites, norketamine and hydroxynorketamine. While these results are preclinical rather than clinical, they are very positive because they enable us to progress and potentially accelerate the programme.
Proactive: Anthony, why are these PK data important for the SVN-002 programme?
Anthony Tennyson: For the FDA to permit a 505(b)(2) pathway or cross-reference an approved package, it needs confidence that exposure levels of the active pharmaceutical ingredient and its major metabolites are comparable for safety reasons before efficacy studies begin.
We established that both peak exposure and total exposure for esketamine and its major metabolites fall within acceptable ranges when delivered sublingually and buccally compared with intranasally. This means we can return to the FDA and seek a refined toxicology package, which we believe could accelerate the programme and reduce development timelines.
Proactive: What's the opportunity for Solvonis and SVN-002?
Anthony Tennyson: We believe the opportunity is substantial. J&J uses Spravato for treatment-resistant depression, but the alcohol use disorder treatment market in the US is between four and five times larger.
Moderate to severe alcohol use disorder affects an estimated 15 million American adults. There has been very limited innovation in treating this chronic disease over recent decades. We are seeking to develop an innovative treatment that can provide hope for individuals, families and communities affected by it.
This milestone also supports our strategy of cautious capital expenditure and capital efficiency through the 505(b)(2) pathway. It potentially allows us to cross-reference an approved medicine's preclinical package. We licensed a Phase 1 programme and, subject to successful completion of a narrow toxicology package, could be in a position to apply for approval to move directly into Phase 2.
Proactive: What's next for SVN-002, Anthony?
Anthony Tennyson: The next step is to take these positive PK data to the FDA and seek guidance on the scope of the toxicology package. We believe the data support a request for a narrow toxicology package.
Following FDA feedback and successful completion of that work, we would submit an IND application seeking approval for a planned Phase 2b trial for moderate to severe alcohol use disorder in the US market.
