SZN-1326 / Surrozen - LARVOL DELTA

A Phase 1/1b, Three-Part, Randomised, Placebo-Controlled, Single- and Multiple-Ascending-Dose Studyto Evaluate the Safety, Pharmacokinetics, and Activity of SZN-1326 in Healthy Volunteers and in Subjects with Moderate to Severe Ulcerative Colitis (ANZCTR) - P1 | N=68 | Terminated | Sponsor: Surrozen Operating, Inc. | Recruiting ➔ Terminated

Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

The potential of ARL4C and its-mediated genes in atherosclerosis and agent development. (PubMed, Front Pharmacol) - "Many agents, including ABCA1 agonists (CS-6253, IMM-H007, RG7273, and R3R-01), FLNA antagonist sumifilam, LRP6 inhibitor BI-905677 and agonist SZN-1326, and SOX2 inhibitor STEMVAC, were investigated in clinical trials. Thus, ARL4C and its regulated genes may be a potential target for drug development. Thus, we focus on the role of ARL4C and its-mediated genes in atherosclerosis and agent development, which provide insights for the identification, research, and drug development of novel targets."

Journal • Review • Atherosclerosis • Cardiovascular • Colorectal Cancer • Hepatology • Liver Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ABCA1 • ALDH1A3 • SNAI2 • SOX2

Surrozen Provides Corporate Update on Clinical Programs (GlobeNewswire) - P1 | N=37 | "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....Several subjects at higher dose levels experienced asymptomatic liver transaminase elevations, including four subjects with grade 3 ALT and AST elevations."

Discontinued • P1 data • Immunology • Inflammation • Inflammatory Bowel Disease

Surrozen Provides Third Quarter 2023 Financial Results (Yahoo Finance) - "SZN-1326: Phase 1a study in healthy volunteers is ongoing and we expect to announce data in Q1 2024. We expect to initiate a Phase 1b clinical study in patients with ulcerative colitis in 2024 and anticipate proof-of-concept data may be available in the second half of 2024."

New P1 trial • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Surrozen Provides First Quarter 2023 Financial Results and Corporate and Pipeline Updates (GlobeNewswire) - "SZN-1326: Re-initiated the SZN-1326 Phase 1a clinical trial in healthy volunteers during the second quarter of 2023; enrollment ongoing."

Enrollment status • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SZN-1326, A WNT MIMETIC, DECREASED INTESTINAL FIBROSIS IN A DEXTRAN SULFATE SODIUM (DSS)-INDUCED CHRONIC COLITIS MOUSE MODEL (DDW 2023) - "Conclusion : In a chronic mouse colitis model, SZN-1326 at various dosing regimens improved intestinal epithelial repair, and decreased colitis-associated collagen deposition. In contrast, anti-TNFa antibody treatment slightly decreased collagen deposition without any improvement in colon histology in this model."

Preclinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

SURROZEN, INC./DE Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-K) (Market Screener) - "We initiated a Phase 1 clinical trial in the second quarter of 2022 for SZN-1326...We anticipate initiating a Phase 1b clinical trial in ulcerative colitis patients in 2024 and expect proof of concept data to be potentially available in the second half of 2024."

New P1 trial • P1 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Surrozen Provides Fourth Quarter and Full Year 2022 Financial Results and Update on Clinical Pipeline and Corporate Progress (GlobeNewswire) - "Surrozen is initially developing SZN-1326 for moderate to severe ulcerative colitis. Expect to re-initiate a Phase 1a clinical trial for SZN-1326 in healthy volunteers by mid-2023 with a lower dose based on the Minimum Anticipated Biological Effect Level (MABEL) following the evaluation of the clinical data and further preclinical work. Expect Phase 1a data in healthy volunteers by the end of 2023. Anticipate potential proof-of-concept data in ulcerative colitis (Phase 1b) in the second half of 2024." "

New P1 trial • P1 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Surrozen Reports Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - "Surrozen announced today that it voluntarily paused enrollment in the single ascending dose (SAD) portion of the Company’s Phase 1 clinical trial evaluating SZN-1326 in healthy volunteers following the observation of treatment-related adverse events. Several subjects experienced asymptomatic liver transaminase elevations, including three subjects with grade 3 ALT and AST elevations....Research and development expenses for the third quarter ended September 30, 2022 were $8.6 million, as compared to $10.4 million for the same period in 2021. The decrease was primarily due to the completion of manufacturing drug substance for SZN-1326 and SZN-043 in 2021."

Commercial • Enrollment status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SZN-1326, A TETRAVALENT, BISPECIFIC ANTIBODY DEVELOPED FOR THE TREATMENT OF ULCERATIVE COLITIS, HAS A FAVORABLE PROFILE IN 13-WEEK GLP TOXICITY STUDIES (UEGW 2022) - "SZN-1326 has a favorable safety profile in 13-week rat and cynomolgus monkey GLP toxicology studies. The minimal, non-adverse, clinical pathology findings in rats were not correlated with any macro- or microscopic histopathological changes. Thus, the NOAEL is the highest IV administered dosage of 75mg/kg/dose with no SZN-1326 related adversity observed at 30 mg/kg dosed SC."

Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • FZD5

SZN-1326, A WNT MIMETIC, IMPROVED EPITHELIAL HEALING AND DECREASED COLLAGEN DEPOSITION IN A DEXTRAN SULFATE SODIUM-INDUCED COLITIS MOUSE MODEL (UEGW 2022) - " In an acute mouse IBD model, SZN-1326 treatment, in a dose-dependent manner, induced mucosal healing and restored the epithelial barrier resulting in reduced inflammation, reduced colitis-associated collagen deposition, improved body weight, and reduced disease activity."

Preclinical • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • COL1A1 • CXCL8 • IL6 • TNFA

Surrozen Presents Data on Two Lead Therapeutic Candidates at United European Gastroenterology (UEG) Week (GlobeNewswire) - "SZN-043 preclinical data shows rapid, transient increases in hepatocyte proliferation and was well tolerated in non-clinical toxicology studies; SZN-1326 preclinical data shows improved intestinal epithelial healing, restored epithelial barrier, and reduced colitis-associated collagen deposition and was well tolerated in non-clinical toxicology studies...Surrozen, Inc...announced the presentation of data supporting the continued development of its lead therapeutic programs at United European Gastroenterology Week (UEGW), being held Oct. 8-11 in Vienna."

Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SZN-1326 PROMOTES COLONIC MUCOSAL HEALING IN AN ACUTE INJURY MODEL OF IBD BY FIRST ACCELERATING EPITHELIAL REGENERATION AND SECONDARILY REDUCING INFLAMMATION (DDW 2022) - "Conclusion : In this acute damage context, SZN-1326 promoted mucosal healing by transiently inducing epithelial progenitor cell expansion and accelerating epithelial repair. Secondary to its initial impact on the epithelium, SZN-1326 reduced stromal and immune cytokine signaling and immune cell infiltration."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • FZD5

Surrozen Initiates Dosing in Phase 1 Clinical Trial of SZN-1326 for Moderate to Severe Ulcerative Colitis (GlobeNewswire) - "Surrozen, Inc...announced that the first subject has been dosed in its three-part Phase 1 clinical trial to evaluate SZN-1326 for the potential treatment of moderate to severe ulcerative colitis. The trial initiation is approximately one quarter earlier than previously expected."

Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Robust colonic epithelial regeneration and amelioration of colitis via FZD-specific activation of Wnt signaling. (PubMed, Cell Mol Gastroenterol Hepatol) - "It is feasible to design Wnt mimetics such as SZN-1326-p that impact damaged intestine epithelium specifically and restore its physiological functions, an approach that holds promise for treating epithelial damage in IBD."

Journal • Dyslipidemia • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • FZD5 • RSPO1 • RSPO2 • SPON1

Surrozen Publishes Article in Cellular and Molecular Gastroenterology and Hepatology Demonstrating that SZN-1326, a Selective Wnt Mimetic, Stimulated Robust Colon Epithelial Regeneration and Ameliorated Colitis in an Acute Model of Inflammatory Bowel Disease (IBD) (GlobeNewswire) - "Surrozen, Inc...announced today the publication of an article by Surrozen scientists in the journal Cellular and Molecular Gastroenterology and Hepatology. The results seen with one of Surrozen’s proprietary Wnt mimetic antibodies highlight the potential for this novel approach to treating inflammatory bowel disease....SZN-1326 demonstrated the most rapid and robust repair of the injured colon epithelium without affecting normal epithelium and without causing hyperplasia....'SZN-1326 is initially being developed for ulcerative colitis and we look forward to initiating Phase 1 clinical trials in the third quarter of 2022...'"

New P1 trial • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

"$SRZN Surrozen Publishes Article in Cellular and Molecular Gastroenterology and Hepatology Demonstrating that SZN-1326, a Selective Wnt Mimetic, Stimulated Robust Colon Epithelial Regeneration and Ameliorated Colitis https://t.co/E0ZtFJpsZn" (@stock_titan)

Gastroenterology • Gastrointestinal Disorder • Hepatology • Immunology

Surrozen Reports Fourth Quarter and Full Year 2021 Financial Results (GlobeNewswire) - "Research and Development Expenses: Research and development expenses for the three and twelve months ended December 31, 2021 were $10.9 million and $40.2 million, respectively, as compared to $8.7 million and $25.7 million, respectively, for the same periods of 2020. The increases were primarily due the increased external costs as we continue to invest in research and development activities related to SZN-1326..."

Commercial • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

SZN-1326 promotes colonic mucosal healing in an acute injury model of IBD by first accelerating epithelial regeneration and secondarily reducing inflammation (ECCO-IBD 2022) - "Conclusion In this acute damage context, SZN-1326 promoted mucosal healing by transiently inducing epithelial progenitor cell expansion and accelerating epithelial repair. Secondary to its initial impact on the epithelium, SZN-1326 reduced stromal and immune cytokine signaling and immune cell infiltration."

Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

A Phase 1/1b, Three-Part, Randomised, Placebo-Controlled, Single- and Multiple-Ascending-Dose Studyto Evaluate the Safety, Pharmacokinetics, and Activity of SZN-1326 in Healthy Volunteers and in Subjects with Moderate to Severe Ulcerative Colitis (ANZCTR) - P1 | N=68 | Not yet recruiting | Sponsor: Surrozen Operating, Inc.

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Surrozen Announces Key 2022 Milestones for Lead Programs and Acceleration of Research Pipeline (GlobeNewswire) - "SZN-1326 for Moderate to Severe Ulcerative Colitis and SZN-043 for Severe Alcoholic Hepatitis...Following the recent completion of IND-enabling GLP toxicology studies, Surrozen expects to initiate Phase 1 clinical trials of both SZN-1326 and SZN-043 in healthy volunteers in the third quarter of 2022."

New P1 trial • Inflammatory Bowel Disease

Surrozen Reports Third Quarter 2021 Financial Results (GlobeNewswire) - "SZN-1326; Plan to initiate Phase 1a clinical trial in healthy volunteers in 2022...Research and development expenses for the three and nine months ended September 30, 2021 were $10.4 million and $29.3 million, respectively...The increases were primarily due the increased external costs related to SZN-1326 and SZN-043 and the increase in employee-related costs, including stock-based compensation expenses, as a result of a higher headcount in support of progressing our research and development programs towards the clinic."

Commercial • New P1 trial • Inflammatory Bowel Disease

Surrozen Presented Data Supporting Potential of SZN-1326 at the 2021 United European Gastroenterology Week (GlobeNewswire) - "Surrozen...announced today that data from its inflammatory bowel disease (IBD) program, including preclinical studies of SZN-1326 showing colonic mucosal healing in an acute injury model were presented during the 2021 United European Gastroenterology Week. The congress, organized by United European Gastroenterology, is being held October 3-5."

Preclinical • Inflammatory Bowel Disease

[VIRTUAL] PHARMACOKINETIC AND NONCLINICAL SAFETY EVALUATION OF SZN-1326, A WNT SIGNAL ACTIVATOR, IN NON-HUMAN PRIMATES (UEGW 2021) - "The data from these studies indicate that SZN-1326 can be safety administered to NHPs, with PK suitable for use in humans, and support further investigation of this molecule in the setting of epithelial regeneration and mucosal healing in IBD."

Clinical • PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

[VIRTUAL] SZN1326, A WNT AGONIST, WAS SUPERIOR TO ANTI-IL12/23P40 AND ANTI-TNF-A ANTIBODIES IN RESTORING EPITHELIAL INTEGRITY AND MITIGATING COLITIS IN A CHRONIC DSS MODEL (UEGW 2021) - "In a chronic IBD model, administration of as little as 4 doses of 0.3 mg/kg of SZN-1326 starting on day 23 stimulated intestinal epithelial regeneration, induced mucosal healing and restored the epithelial barrier resulting in reduced inflammation and disease activity. Anti-IL12/23p40 antibody at 10 mg/kg given 8 times starting on Day 7 improved colon histology and reduced serum levels of IL-6 but had no effect on DAI. Treatment with anti-TNF-a antibody led only to serum lipocalin-2 reduction without any effects on DAI or colon histology."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • IL12A • IL6 • LCN2