ebrasodebart (Ent001) / Enthera - LARVOL DELTA

A novel monoclonal antibody blocks TMEM219 signal and prevents type 1 diabetes (EASD 2025) - "Our findings indicate that direct inhibition of TMEM219 signaling, which is dysregulated in T1D, preserved the beta cell mass and may thus represent a novel therapeutic opportunity for patients with T1D."

Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus • CD4 • CD8 • IGFBP3

Targeting of the IGFBP3/TMEM219 pathway restores intestinal stem cells capability of healing mucosa in gastrointestinal autoimmune disorders. (PubMed, Pharmacol Res) - "In vivo, in models of DSS-induced chronic colitis and in inflammatory-mediated carcinogenesis, Ent001 significantly improved disease activity index and histological score, restored mucosal morphology and abrogated the development of carcinomas, leading to mucosal healing. In summary, Ent001 represents a novel IGFBP3/TMEM219 inhibitor to be further tested and developed in clinical studies as a novel therapeutic in immune-mediated and inflammatory intestinal diseases."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • CASP8 • IGFBP3

A Novel Monoclonal Antibody Blocks TMEM219 Signal and Prevents T1D (ADA 2025) - "Our findings indicate that direct inhibition of TMEM219 signaling, which is dysregulated in T1D, preserved the beta cell mass and may thus represent a novel therapeutic opportunity for patients with T1D."

Diabetes • Metabolic Disorders • Obesity • Type 1 Diabetes Mellitus • CD4 • CD8 • IGFBP3

Enthera Pharmaceuticals Announces Publication in the Journal of Clinical Investigation Supporting the Clinical Development of Ebrasodebart (Businesswire) - "Preclinical data demonstrate crucial role of Transmembrane Protein 219 (TMEM219) in exacerbating inflammatory bowel disease (IBD) by inducing intestinal epithelial stem cell (ISC) death and impairing mucosal healing; Findings support Phase 1 clinical development of Enthera’s lead candidate, Ebrasodebart (Ent001), a monoclonal antibody targeting the IGFBP3/TMEM219 pathway."

Preclinical • Inflammatory Bowel Disease

Ebrasodebart (Ent001) First in Human trial in healthy volunteers: pharmacokinetic results and predicted therapeutic concentrations to preserve mucosal healing in patients with Ulcerative Colitis (ECCO-IBD 2025) - "Conclusion These data indicate that ebrasodebart concentrations with predictable PK and expected therapeutic efficacy can be safely reached in humans, and remained significantly below the NOAEL in monkeys, suggesting a potential for a wide therapeutic window in patients. A multicentric Phase 1b, randomized, double-blind, placebo-controlled trial is ongoing to evaluate safety, tolerability, PK, immunogenicity and preliminary efficacy of multiple ascending doses of ebrasodebart in patients with moderately to severely active UC."

Clinical • P1 data • PK/PD data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CASP8 • IGFBP3

Enthera Pharmaceuticals Appoints Lisa M. Olson as CEO and Announces Clinical Trial Progress with Ent001 (Businesswire) - P1a | N=30 | "Enthera also announced completion of Ent001’s Phase 1a single-ascending dose trial in healthy volunteers, establishing a positive safety and tolerability profile and enabling the start of the Phase 1b multiple ascending dose trial in ulcerative colitis (UC) patients....The trial results established a very positive safety and tolerability profile for Ent001 without any observations of drug-related clinically relevant adverse reactions up to the highest dose tested (10mg/kg). The pharmacokinetics (PK) were linear, and the exposures reached in this study fully cover the concentrations that are predicted to be effective in patients, based on the maximum effective dose in animal disease models of UC....Based on this, Enthera has initiated a multiple ascending dose (MAD) Phase 1b clinical trial in patients with moderately to severely active UC."

P1 data • Trial completion • Trial status • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

GENERATION, CHARACTERIZATION AND SCREENING OF ENT001 A NEW THERAPEUTIC TOOL FOR IBD (UEGW 2023) - "Ent001 may represent a novel IGFBP3/TMEM219 inhibitor to be further tested and developed in in vivo models and in clinical studies as a novel therapeutic in human diseases."

Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • CASP8 • IGFBP3

Enthera Pharmaceuticals Initiates Phase 1 Clinical Trial with Lead Candidate Ent001 (Businesswire) - "Enthera Pharmaceuticals...announces the start of a Phase 1 first-in-human (FIH) clinical trial with its lead candidate Ent001. Ent001 is a monoclonal antibody (mAb) targeting the IGFBP3/TMEM219 pathway, which plays a critical role in both inflammatory bowel disease (IBD) and type 1 diabetes (T1D)....The trial in healthy volunteers will evaluate Ent001’s safety and tolerability and establish optimal dose levels for subsequent trials in patients with IBD and T1D, the target indications for the next stage of Ent001’s clinical development."

Trial status • Inflammatory Bowel Disease

Enthera Pharmaceuticals Extends Series A Financing, Raising a Total Of €35m (Businesswire) - "Enthera Pharmaceuticals...announces the final closing of its Series A financing, with a total financing of €35m...Ent001 is the only drug in development with the potential to restore...the original intestine structure in inflammatory bowel disease, in order to re-establish organ function."

Financing • Inflammatory Bowel Disease