Surrozen is dropping its sole clinical asset after the drug failed at Phase I, as the company considers a move into ophthalmology instead.
Development of SZN-043 is being discontinued in severe alcohol-associated hepatitis. The therapy was under evaluation in two Phase I trials – one (ACTRN12624000194561) in patients with severe alcohol-associated hepatitis to assess the safety, tolerability and pharmacokinetics (PK) of the therapy, and a single and multiple ascending dose study (ACTRN12622000392763) to assess the safety and PK in healthy volunteers and patients with liver cirrhosis.
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The US-based biotech said that while SZN-043 was safe and well-tolerated and demonstrated positive changes in liver function assays, there was not a sufficient early signal of clinical benefit to warrant further investment.
In November 2024, Surrozen seemed filled with hope for SZN-043, saying that the therapy was “showing signs of providing a clinical benefit to patients”.
A move to ophthalmology
The company, freshly armed with private placement funding, will now look to advance their three ophthalmology assets to the clinic. Surrozen will receive $70m on 26 March 2025, and a second $105m tranche contingent on US Food and Drug Administration (FDA) clearance of the SZN-8141 Investigational New Drug (IND) application, expected in 2026. The financing was led by Venrock Healthcare Capital Partners and included other major life sciences investors.
Surrozen CEO Chris Parker said: “Given the significant progress and potential of our ophthalmology programs, we have decided to focus on our robust ophthalmology pipeline. Importantly, our retinal ophthalmology programs represent novel combinations of clinically validated targets for treating a broad spectrum of serious eye diseases.”
Investors do not seem overly convinced by Surrozen’s change in direction, with the company’s stock, listed on the Nasdaq exchange, taking a 9.43% drop from $13.25 at market open on 24 March before the news, to a close of $12.00.
Surrozen has partnered with Boehringer Ingelheim to develop its bi-specific antibody targeting Frizzled 4 (Fzd4)-mediated Wnt signalling, SZN-413, which is set to be evaluated in diabetic retinopathy. Surrozen is developing another two therapies, SZN-8141 and SZN-8143, which also activate the Wnt Pathway for tissue repair and regeneration.
SZN-8141 combines Fzd4 agonism and vascular endothelial growth factor (VEGF) antagonism, which Surrozen has hopes for in diabetic macular oedema (DME) and neovascular age-related macular degeneration (wet AMD). Meanwhile, SZN-8143 combines Fzd4 agonism, VEGF antagonism, and interleukin-6 (IL-6) antagonism that the company hopes will show benefit as a treatment of DME/wet AMD/uveitic macular oedema (UME).
Surrozen said that modulation of Wnt signalling has the potential to be relevant in a broad range of highly prevalent eye diseases.
The biotech has not given a timeline yet for when it expects to advance these candidates to Phase I studies.
GlobalData has market forecasts for various eye disease, with estimates that the AMD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) could reach $27.5bn in 2031 while the DME market is expected to reach $9.6bn across 7MM in the same year.
GlobalData is the parent company of Clinical Trials Arena.
