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Announces strategic prioritization of clinical programs to focus on development of SZN-043 for Alcohol-Associated Hepatitis
SZN-043
- Completed enrollment for the Phase 1a clinical trial in chronic liver disease patients and healthy volunteers
- Expect to announce Phase 1a safety and pharmacodynamic data in Q1 2024
- Expect to initiate enrollment in the Phase 1b clinical trial in patients with alcohol-associated hepatitis in 2024 and anticipate proof-of-concept data may be available in the second half of 2024
SZN-1326
- Company discontinues clinical development of SZN-1326 in inflammatory bowel disease due to the challenges of identifying a safe and effective dose for further development and other strategic considerations
$43.4 million in cash, cash equivalents, and marketable securities as of September 30, 2023 resulting in cash runway into 2025
SOUTH SAN FRANCISCO, Calif., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Surrozen, Inc. ("Surrozen" or the "Company") (NASDAQ:SRZN), a company pioneering targeted therapeutics that selectively activate the Wnt Pathway for tissue repair and regeneration, today announced that enrollment for the SZN-043 Phase 1a clinical trial in patients with chronic liver disease and healthy volunteers is complete. The Company expects to release safety and pharmacodynamic data in Q1 2024. In addition, Surrozen anticipates initiating enrollment in the Phase 1b portion of the study in patients with alcohol-associated hepatitis soon with proof-of-concept data from the study potentially available in the second half of 2024.
Following the completion of the Phase 1 single ascending dose clinical trial for SZN-1326, the Company will discontinue development of SZN-1326 in inflammatory bowel disease (IBD). The decision was based on the challenges of identifying a safe and potentially effective dose along with strategic considerations including the significant clinical development expenses and market competition in IBD. SZN-1326 has been evaluated in a Phase 1 single ascending dose clinical trial in 37 healthy volunteers in doses ranging from 0.01mg to 25mg. Several subjects at higher dose levels experienced asymptomatic liver transaminase elevations, including four subjects with grade 3 ALT and AST elevations. The Company previously reported that 3 of these 4 subjects had grade 3 ALT and AST elevations in 2022. No other clinically significant laboratory abnormalities were observed, and the transaminase elevations resolved spontaneously in all subjects. No serious adverse events were observed during the study. While no safety signal was observed at lower doses, lower dose levels would not be expected to activate Wnt signaling and produce a pharmacologic effect in the intestine.
"Although the decision to discontinue the SZN-1326 inflammatory bowel disease development program is disappointing, we want to thank the subjects, our collaborators and the medical professionals who participated and helped advance our understanding of Wnt mimetics," said Craig Parker, President and Chief Executive Officer of Surrozen. "One of the compelling aspects of Wnt biology and our technologies is the potential to apply them across a range of potential tissues and diseases. Importantly, SZN-043 represents a different antibody technology and approach to modulating Wnt signaling compared to SZN-1326. Given the potential challenges in IBD and attractive opportunities in other areas, we are excited to continue to progress SZN-043 for alcohol-associated hepatitis, advance our pipeline of research stage programs and support our collaboration with Boehringer Ingelheim to advance SZN-413 into development."
About SZN-043 for Alcohol-Associated Hepatitis
SZN-043 is the first development candidate using Surrozen's SWEETS™ technology. Surrozen is developing SZN-043 for severe liver diseases, initially focusing on alcohol-associated hepatitis. The Company expects to announce safety and pharmacodynamic data from SZN-043 Phase 1a clinical trial in patients with chronic liver disease and in healthy volunteers in Q1 2024. The company anticipates enrolling patients with alcohol-associated hepatitis in a Phase 1b clinical trial in 2024 and expects that proof-of-concept data from this trial may be available in the second half of 2024.
About SZN-413 for Retinal Diseases
SZN-413 is a bi-specific antibody targeting Fzd4-mediated Wnt signaling designed using Surrozen's SWAP™ technology. It is currently being developed for the treatment of retinal vascular-associated diseases. Data generated by Surrozen with SZN-413 in preclinical models of retinopathy demonstrated that SZN-413 could potently stimulate Wnt signaling in the eye, induce normal retinal vessel regrowth, suppress pathological vessel growth and reduce vascular leakage. This novel approach could thus potentially allow for regeneration of healthy eye tissue, not only halting retinopathy, but possibly allowing for a full reversal of the patient's disease.
In the fourth quarter of 2022, Surrozen entered into a strategic partnership with Boehringer Ingelheim for the research and development of SZN-413 for the treatment of retinal diseases. Under the terms of the agreement, Boehringer Ingelheim received an exclusive, worldwide license to develop SZN-413 and other Fzd4-specific Wnt-modulating molecules for all purposes, including as a treatment for retinal diseases, in exchange for an upfront payment to Surrozen of $12.5 million. Surrozen will also be eligible to receive up to $587.0 million in success-based development, regulatory, and commercial milestone payments, in addition to mid-single digit to low-double digit royalties on sales. After an initial period of joint research, Boehringer Ingelheim will assume all development and commercial responsibilities.
About Wnt Signaling
Wnt signaling plays key roles in the control of development, homeostasis, and regeneration of many essential organs and tissues, including liver, intestine, lung, kidney, retina, central nervous system, cochlea, bone, and others. Modulation of Wnt signaling pathways has potential for treatment of degenerative diseases and tissue injuries. Surrozen's platform and proprietary technologies have the potential to overcome the limitations in pursuing the Wnt pathway as a therapeutic strategy.
About Surrozen
Posted In: SRZN
