Surrozen (SRZN) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Clinical program overview

• DUET study will begin later this year, featuring a two-part design: single ascending dose followed by dose expansion with an active comparator, Vabysmo.

• Primary endpoints include safety, tolerability, anatomical outcomes, durability, and exploratory reperfusion metrics, with initial data expected in the second half of 2027.

• Both treatment-naive and experienced patients will be enrolled in part one, while only treatment-naive will be included in part two.

• Dose selection in part one aims to identify two doses for further study, with three monthly doses and a four-month follow-up.

• Active comparator Vabysmo was chosen for its commercial relevance and incremental improvements over other therapies.

Mechanistic rationale and differentiation

• The lead molecule combines VEGF inhibition and Wnt agonism, aiming for best-in-disease potential in DME and possibly wet AMD.

• Preclinical data show significant reduction in avascular area and superior performance to VEGF monotherapies.

• Wnt mechanism is uniquely suited for reperfusion, a key unmet need not addressed by current VEGF therapies.

• Exploratory endpoints include OCT angiography and ultra-wide fluorescein angiography to assess non-perfusion and ischemic index.

• Differences in potency and design distinguish this molecule from competitors like Merck’s Restoret.

Safety, manufacturing, and trial design

• Preclinical and early clinical data suggest a favorable safety profile, with no major concerns identified.

• An FcRn mutation is included to reduce systemic exposure and potential safety liabilities.

• Manufacturing is managed by Lonza, following established protocols for intravitreal ophthalmology therapeutics.

• Inclusion/exclusion criteria are standard, with a focus on accelerating enrollment and ensuring comparability to contemporary studies.