Takeda Enters Collaboration and Licensing Agreement with Zedira and Dr. Falk Pharma to Develop First-in-Class Celiac Disease Therapy

Takeda (TSE:4502/NYSE:TAK), Zedira and Dr. Falk Pharma GmbH right now introduced a collaboration and licensing settlement to develop ZED1227/TAK-227, a Phase 2b investigational remedy for the remedy of celiac illness. TAK-227 is a possible first-in-class remedy designed to stop the immune response to gluten in celiac illness, a critical autoimmune illness the place the ingestion of gluten leads to irritation and injury to the small gut. There are at present no authorized therapies for the remedy of celiac illness.

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“The continued development of TAK-227 in partnership with Zedira and Dr. Falk Pharma has the potential to offer a meaningful benefit to patients with celiac disease who suffer from symptoms and ongoing intestinal injury despite maintaining a gluten-free diet,” mentioned Chinwe Ukomadu, M.D., Ph.D., head, Gastroenterology Therapeutic Area Unit at Takeda. “With three novel programs now in the clinic, Takeda is at the forefront of developing transformative therapies for celiac disease and is advancing multiple therapies for patients living with this challenging lifelong autoimmune condition.”

TAK-227 (ZED1227)¹ is a selective, oral small molecule designed to inhibit tissue transglutaminase (TG2), an enzyme that generates immunogenic gluten peptide fragments upon the breakdown of gluten within the abdomen and intestinal tissue. TAK-227 targets the dysregulated transglutaminase to stop mucosal injury within the small gut by stopping the physique’s immune response to gluten, a illness course of mediated by activation of gluten-specific T cells. A Phase 2a proof-of-concept research revealed within the New England Journal of Medicine beforehand demonstrated a protecting impact of TAK-227 on the duodenal mucosa and signs throughout a six-week gluten problem.² The compound was additionally discovered to be secure and nicely tolerated.

“Patients with celiac disease urgently need appropriate therapeutic options to manage the significant negative impacts of the disease on health and daily quality of life,” mentioned Roland Greinwald, Ph.D., Managing Director Medicine & Pharmaceutics at Dr. Falk Pharma.

Martin Hils, Ph.D., CEO at Zedira, added “Takeda’s R&D expertise in gastroenterology, commercial footprint, and its strong commitment to develop therapies to treat celiac disease, make it an ideal partner to help us bring TAK-227 to patients.”

Under the phrases of the settlement, Takeda and Dr. Falk Pharma will conduct world medical research for TAK-227 in celiac illness. Takeda will obtain an unique license to develop and commercialize TAK-227 within the United States and different territories outdoors of Europe, Canada, Australia and China. Zedira and Dr. Falk Pharma will obtain an upfront cost and are eligible to obtain potential growth, regulatory and business milestones, in addition to royalties on internet gross sales. Originally found by Zedira, Dr. Falk Pharma licensed the European rights to ZED1227 from Zedira in 2011 and assumed accountability for preclinical and medical growth of this system.

Takeda is advancing a portfolio of investigational therapies for the potential remedy of celiac illness. In addition to TAK-227, Takeda is growing two different investigational celiac illness therapies that not too long ago entered Phase 2 medical trials. TAK-062 is a possible best-in-class, extremely potent glutenase – a protein that degrades ingested gluten – that was computationally engineered to deal with celiac illness. TAK-101 is a possible first-in-class, immune-modifying nanoparticle containing gliadin proteins designed to promote immune tolerance to gluten in celiac illness by stopping gliadin-specific T-cell activation.

About Celiac Disease

Celiac illness is a systemic, immune-mediated dysfunction characterised by persistent enteropathic irritation, and precipitated by publicity to dietary gluten in genetically predisposed people.³ Global prevalence of celiac illness is ~1%, with highest charges in ladies, in family members of people with celiac illness, and in these with different immune-mediated problems; prevalence of celiac illness is rising worldwide, but many instances stay undetected or not formally recognized.^4,5,6 The quantity of each day tolerable gluten varies broadly amongst people with celiac illness. Although some can tolerate >50 mg/day, others develop mucosal abnormalities with gluten consumption of 10 mg/day, and mucosal injury has been related with persistent exposures of as little as 1 mg/day.^7,8,9 Celiac illness may cause signs, together with belly ache, diarrhea, nausea, and vomiting. Long-term problems of celiac illness could embody malnutrition, accelerated osteoporosis, nervous system issues and issues associated to replica. There is not any authorized remedy for celiac illness. The solely out there administration possibility for sufferers is sustaining a gluten-free weight loss program, which includes strict, lifelong avoidance of publicity to gluten proteins from wheat, barley, and rye, which isn’t at all times efficient.¹⁰

About Takeda

Takeda is a worldwide, values-based, R&D-driven biopharmaceutical chief headquartered in Japan, dedicated to uncover and ship life-transforming therapies, guided by our dedication to sufferers, our individuals and the planet. Takeda focuses its R&D efforts on 4 therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We additionally make focused R&D investments in Plasma-Derived Therapies and Vaccines. We are specializing in growing extremely revolutionary medicines that contribute to making a distinction in individuals’s lives by advancing the frontier of recent remedy choices and leveraging our enhanced collaborative R&D engine and capabilities to create a strong, modality-diverse pipeline. Our workers are dedicated to enhancing high quality of life for sufferers and to working with our companions in well being care in roughly 80 international locations and areas. For extra data, go to https://www.takeda.com.

About Zedira GmbH

The Darmstadt (Germany) based mostly biotech firm has a give attention to celiac illness and different transglutaminase-linked situations within the areas of autoimmunity, fibrotic ailments, and thrombosis. The firm develops, produces, and markets specialty reagents and kits for analysis and growth in addition to for medical diagnostics. Zedira established a pipeline of drug candidates tailored to particular indications based mostly on a collection of patented artificial transglutaminase blockers. ZED1227 is the primary direct-acting transglutaminase inhibitor in medical growth. Zedira is a portfolio firm of the German High-Tech Gründerfonds.

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH has been growing and advertising revolutionary medicines to deal with a variety of gastrointestinal problems like inflammatory bowel illness or eosinophilic esophagitis in addition to hepatobiliary problems resembling major biliary cholangitis for over 60 years. As the worldwide consultants in digestive and metabolic medication, the corporate brings collectively physicians, scientists, and sufferers to devise new and highly effective approaches to affected person care. Dr. Falk Pharma engages in pre-clinical and medical stage analysis that goals to meaningfully enhance therapeutic apply in addition to affected person well being and well-being. A family-owned business with a worldwide presence, Dr. Falk Pharma has ten associates in Europe and Australia and is constantly rising. The firm has its headquarters and R&D amenities in Freiburg, Germany, its pharmaceutical merchandise are manufactured in Europe, primarily at websites in Germany, France and Switzerland. Dr. Falk Pharma GmbH employs roughly 990 people globally, thereof 218 in Freiburg.

Further data on Dr. Falk Pharma could be discovered on-line: https://drfalkpharma.com

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¹ Büchold C, Hils M, Gerlach U, Weber J, Pelzer C, Heil A, Aeschlimann D, Pasternack R. Features of ZED1227: The First-In-Class Tissue Transglutaminase Inhibitor Undergoing Clinical Evaluation for the Treatment of Celiac Disease. Cells. 2022; 11(10):1667. https://doi.org/10.3390/cells11101667

² Schuppan D, Mäki M, Lundin KEA, Isola J, Friesing-Sosnik T, Taavela J, Popp A, Koskenpato J, Langhorst J, Hovde Ø, Lähdeaho ML, Fusco S, Schumann M, Török HP, Kupcinskas J, Zopf Y, Lohse AW, Scheinin M, Kull Ok, Biedermann L, Byrnes V, Stallmach A, Jahnsen J, Zeitz J, Mohrbacher R, Greinwald R; CEC-3 Trial Group. A Randomized Trial of a Transglutaminase 2 Inhibitor for Celiac Disease. N Engl J Med. 2021 Jul 1;385(1):35-45. doi: 10.1056/NEJMoa2032441. PMID: 34192430.

³ Ludvigsson J, Leffler D, Bai J, et al. The Oslo definitions for coeliac illness and associated phrases. Gut. 2013 Jan;62(1):43-52.

⁴ Caio G, Volta U, Sapone A, Leffler DA, De Giorgio R, Catassi C, Fasano A. Celiac illness: a complete present evaluation. BMC Med. 2019 Jul 23;17(1):142.

⁵ King J, Jeong J, Underwood F, et al. Incidence of Celiac Disease Is Increasing Over Time: A Systematic Review and Meta-analysis. Am J Gastroenterol. 2020 Apr;115(4):507-525.

⁶ Al-Toma A, Volta U, Auricchio R, et al. European Society for the Study of Coeliac Disease (ESsCD) guideline for coeliac illness and different gluten-related problems. United European Gastroenterol J. 2019 Jun;7(5):583-613.

⁷ Biagi F, Campanella J, Martucci S, Pezzimenti D, Ciclitira PJ, Ellis HJ, Corazza GR. A milligram of gluten a day retains the mucosal restoration away: a case report. Nutr Rev. 2004 Sep;62(9):360-3.

⁸ Itzlinger A, Branchi F, Elli L, Schumann M. Gluten-Free Diet in Celiac Disease-Forever and for All? Nutrients. 2018 Nov 18;10(11):1796.

⁹ Akobeng AK, Thomas AG. Systematic evaluation: tolerable quantity of gluten for individuals with coeliac illness. Aliment Pharmacol Ther. 2008 Jun 1;27(11):1044-52

¹⁰ Symptoms & Causes of Celiac Disease. National Institute of Diabetes and Digestive and Kidney Diseases. Available at: https://www.niddk.nih.gov/health-information/digestive-diseases/celiac-disease/symptoms-causes. Last reviewed: October 2020. Last accessed: June 2022

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