{"id":54564,"date":"2023-03-07T11:06:35","date_gmt":"2023-03-07T10:06:35","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/enthera-pharmaceuticals-initiates-phase-1-clinical-trial-with-lead-candidate-ent001\/"},"modified":"2023-03-07T11:06:35","modified_gmt":"2023-03-07T10:06:35","slug":"enthera-pharmaceuticals-initiates-phase-1-clinical-trial-with-lead-candidate-ent001","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/enthera-pharmaceuticals-initiates-phase-1-clinical-trial-with-lead-candidate-ent001\/","title":{"rendered":"Enthera Pharmaceuticals Initiates Phase 1 Clinical Trial with Lead Candidate Ent001"},"content":{"rendered":"
\n

\nPhase 1 study in healthy volunteers lays groundwork for Ent001 evaluation in patients with inflammatory bowel disease and type 1 diabetes<\/b>\n<\/p>\n

MILAN–(BUSINESS WIRE)–Enthera Pharmaceuticals<\/a> (\u201cEnthera\u201d), a biotech company developing first-in-class biologics for selected autoimmune conditions, today 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). Elevated levels of IGFBP3 bind to the TMEM219 receptor, causing apoptosis of both colonic stem cells in the gut and insulin-producing beta cells in the pancreas. Ent001 is designed to bind to TMEM219 and prevent cell death and the inflammation underlying these disease states. The trial in healthy volunteers will evaluate Ent001\u2019s 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\u2019s clinical development.\n<\/p>\n

<\/a><\/p>\n

\n\u201cThe initiation of this trial is a major development milestone for Ent001 and transitions Enthera into a clinical stage company. The data we gather from this study will be instrumental to optimize the development of our lead candidate and enable future development in IBD and T1D,\u201d said Aled Paton Williams, CEO of Enthera<\/b>.\n<\/p>\n

\nThe Phase 1 trial will evaluate Ent001 in up to 30 healthy adult volunteers in a randomised, double-blind, placebo-controlled single ascending dose (SAD) study in the Netherlands. In addition to safety, the trial will assess Ent001\u2019s pharmacokinetics, pharmacodynamics, and immunogenicity.\n<\/p>\n

\n\u201cThis trial builds on our robust preclinical data that revealed a strong safety profile and demonstrated noteworthy results with Ent001\u2019s unique mode of action in well-established animal disease models. We look forward to applying our unique understanding of the recently discovered IGFBP3\/TMEM219 axis to establish Ent001\u2019s potential as a first-in-class therapeutic with the ability to halt and reverse disease progression in IBD and T1D,\u201d said Filippo Canducci, Chief Medical Officer of Enthera<\/b>.\n<\/p>\n

\nAbout Enthera Pharmaceuticals
\n
<\/b>Enthera Srl is a biotech company developing first-in-class biologics to transform the treatment paradigm for specific autoimmune conditions by preserving and re-establishing cell and organ function. The Company\u2019s primary target indications are inflammatory bowel disease (IBD) and type 1 diabetes (T1D). Enthera\u2019s pioneering approach capitalizes on the key discovery of the IGFBP3\/TMEM219 pathway, which is involved in stem cell and beta cell apoptosis in the gut and pancreas, respectively.\n<\/p>\n

\nEnthera is a private company headquartered in Milan, Italy, and founded in 2016 by Prof. Paolo Fiorina and Dr. Francesca D\u2019Addio at BiovelocITA, Italy\u2019s first biotech accelerator. The Company is backed by Sofinnova Partners, AbbVie INC, JDRF T1D Fund, Roche Finance LTD and a number of private investors. Enthera\u2019s discovery engine and assets are protected by a broad portfolio of patents.\n<\/p>\n

\nFor further information: <\/b>www.entherapharmaceuticals.com<\/a>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nEnthera Pharmaceuticals<\/b>
Aled Williams, CEO
\n
info@entherapharmaceuticals.com<\/a><\/p>\n

Trophic Communications<\/b>
Valeria Fisher or Veronika M\u00e1t\u00e9
\n
+49 175 8041816 or +49 160 90816161
\n
enthera@trophic.eu<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Phase 1 study in healthy volunteers lays groundwork for Ent001 evaluation in patients with inflammatory bowel disease and type 1 diabetes MILAN–(BUSINESS WIRE)–Enthera Pharmaceuticals (\u201cEnthera\u201d), a biotech company developing first-in-class biologics for selected autoimmune conditions, today announces the start of a Phase 1 first-in-human (FIH) clinical trial with its lead candidate Ent001. Ent001 is a … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-54564","6":"format-standard","7":"category-industry"},"yoast_head":"\nEnthera Pharmaceuticals Initiates Phase 1 Clinical Trial with Lead Candidate Ent001 - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/enthera-pharmaceuticals-initiates-phase-1-clinical-trial-with-lead-candidate-ent001\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Enthera Pharmaceuticals Initiates Phase 1 Clinical Trial with Lead Candidate Ent001 - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Phase 1 study in healthy volunteers lays groundwork for Ent001 evaluation in patients with inflammatory bowel disease and type 1 diabetes MILAN–(BUSINESS WIRE)–Enthera Pharmaceuticals (\u201cEnthera\u201d), a biotech company developing first-in-class biologics for selected autoimmune conditions, today announces the start of a Phase 1 first-in-human (FIH) clinical trial with its lead candidate Ent001. Ent001 is a ... 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