Key Takeaways

  • Surrozen’s IND for SZN-8141 has become effective, allowing the investigational DME therapy to advance into clinical development
  • The company expects to dose the first patient in the phase 1b/2a DUET study during the fourth quarter of 2026

Surrozen announced that its investigational new drug application for SZN-8141 has become effective, clearing the way for the company to begin clinical development of the investigational therapy in diabetic macular edema (DME).

SZN-8141 is a bifunctional Wnt agonist and vascular endothelial growth factor (VEGF) antagonist antibody designed for intravitreal administration. The investigational therapy is intended to address underlying disease mechanisms through Wnt signaling while also targeting VEGF.

Surrozen expects to dose the first patient in DUET, a phase 1b/2a clinical study evaluating SZN-8141 in patients with DME, during the fourth quarter of 2026.

“FDA clearance of the SZN-8141 IND marks an important milestone for Surrozen as we advance our Wnt-based ophthalmology pipeline into clinical development,” Craig Parker, chief executive officer of Surrozen, said in a statement. “We look forward to initiating the DUET study and evaluating SZN-8141 in patients with diabetic macular edema.”

The IND milestone also triggered the second closing of Surrozen’s two-tranche private placement initiated in March 2025. Subject to the terms and closing conditions of the securities purchase agreement, Surrozen expects the transaction to generate approximately $95.1 million in gross proceeds before placement agent fees and other expenses.

The second closing is expected to occur on or about October 20, 2026. Surrozen said the proceeds are expected to support development of SZN-8141 and SZN-8143, as well as the company’s broader operating activities.

“Importantly, this milestone also satisfies the condition for the second closing of our March 2025 private placement, which is expected to provide approximately $95.1 million in gross proceeds to support the advancement of SZN-8141 and SZN-8143,” Mr. Parker said.