Surrozen gains FDA IND clearance for SZN‑8141 macular edema trial
Surrozen expects to dose DUET's first patient in Q4; clearance also meets a condition for a US$95.1M financing close around Oct. 20.
Adrian Kessler
A study of an experimental injection for diabetic macular edema can begin after Surrozen, Inc. NASDAQSRZN said Friday its FDA investigational new drug application for SZN-8141 had become effective. The clearance also satisfies a milestone for a second private placement closing expected to bring in approximately US$95.1 million gross around Oct. 20, subject to other conditions.
The Oct. 2 release places the first patient dose in the fourth quarter of 2026 and initial data in the second half of 2027. DUET is a Phase 1b/2a study designed to test safety and early signs of activity; the clearance itself supplies no evidence of benefit in patients.
Surrozen is a small-cap biotechnology developer based in South San Francisco, with experimental antibody treatments focused on retinal disease.
Surrozen's NASDAQSRZN shares closed at US$30 on Oct. 1 at 4 p.m. UTC-4, before Friday's announcement. The Oct. 1 close predates the clearance announcement, so it does not show a regular-session market reaction.
Read more: Immunome gains FDA IND clearance for IM-1340 solid tumour study
DUET Starts With a Single Dose
The first part of DUET is open-label and will enroll patients with diabetic macular edema who either have or have not received treatment before. Participants will receive one injection into the eye, then be followed for about three months for safety, drug exposure and exploratory measures of vision and retinal anatomy.
A later randomized, double-masked portion is planned to compare two SZN-8141 dose levels against Vabysmo in approximately 60 previously untreated patients. The protocol calls for three monthly injections and four more months of follow-up to examine how long any effect lasts. Best-corrected vision and optical coherence tomography are among the planned measures, but the company has not reported patient outcomes for SZN-8141.
Surrozen designed SZN-8141 to activate Frizzled 4-mediated Wnt signalling while blocking vascular endothelial growth factor, a target of existing eye medicines. The company says preclinical models showed normal vessel regrowth alongside suppression of abnormal growth; whether that combination helps people will be tested in DUET.
Read more: Wave Life Sciences plans two-year WVE-006 trial after FDA feedback
"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."
Surrozen chief executive Craig Parker said this in the company's Oct. 2 release.
The company expects that second closing around Oct. 20, before fees and subject to the purchase agreement's remaining terms. Investors would receive common shares, pre-funded warrants and Series E warrants under the arrangement, while Surrozen plans to use proceeds for both eye programs and broader operations. Its cash and equivalents stood at US$102.0 million on June 30, according to its second-quarter report dated Aug. 6.
Vabysmo Is DUET's Active Comparator
Roche Holding AG SWXROP OTCMKTSRHHBY makes Vabysmo, the active comparison in DUET's later portion. Roche named the medicine among its leading sales growth drivers in its July 22 report on the first half of 2026, showing the commercial treatment Surrozen will have to measure against.
A second peer, Merck & Co., Inc. NYSEMRK, is testing a Wnt agonist called remigromig in the same disease. In a Sept. 24 release, Merck said both tested doses met its Phase 2b/3 study's noninferiority endpoint against ranibizumab for vision change at week 52. It also reported higher rates of proliferative diabetic retinopathy and vitreous hemorrhage in the remigromig arms, an early safety comparison that Surrozen's trial has yet to produce.
Surrozen expects the second financing closing around Oct. 20, when the remaining conditions will determine whether the proceeds become available. It plans the first DUET patient dose in the fourth quarter of 2026, beginning the study of SZN-8141 in people.
