Surrozen, Inc. has received FDA clearance for its investigational new drug (IND) application for SZN-8141 for the treatment of diabetic macular edema (DME).
The update follows less than 1 month after the biotech company announced its submission.
Let’s begin with the subject of this IND.
SZN-8141 is one of three investigational candidates in Surrozen’s pipeline of proprietary Surrozen Wnt signaling activating proteins (SWAPs).
To get re-familiarized on SWAPs—and the company’s therapeutic approach—click here.
What should we know about it?
The bifunctional antibody combines Frizzled-4 (FZD4)-targeted Wnt agonism with vascular endothelial growth factor (VEGF) inhibition (via an intravitreal [IVT] injection) within a single molecule.
Its proposed indications: DME and wet age-related macular degeneration (AMD).
- The goal: to improve visual function and offer durable anatomic control by addressing vascular leakage and promoting retinal vascular integrity
See here for more on its potential.
Speaking of potential … how has its clinical performance been thus far?
Promising. However, that’s only based on preclinical studies involving a rodent model (hence the need for this IND—to start human clinical evaluations).
The gist of it: SZN-8141 stimulated Wnt signaling and induced normal retinal vessel regrowth while suppressing pathological vessel growth.
Check out more on this preclinical performance.
And regarding this now-cleared IND study?
That would be the phase 1b/2a DUET study.
Unfortunately, the only update we have is the timeframe for when patient dosing is expected to begin (Q4 2026).
- Translation: sometime between now and Dec. 31
Other than CEO Craig Park stating that the company looks forward to initiating the DUET study, Surrozen has not publicly released any information on its planned setup, outcome measures, participants, or duration.
Alas. What else did the company share?
This clearance also paves the way for Surrozen to acquire—subject to applicable closing conditions—additional funding supporting its clinical development plans and broader operating activities.
How much, you ask? An estimated $95.1 million in gross proceeds.
For more on this securities purchase agreement, click here.