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Takeda Partners with MiTest Health to Launch Innovative Disease Risk Prediction Tool to Redefine Crohn’s Disease Management

December 13, 2019 Lexington, MA
  • The validated predictive tool[i] – an important advancement in precision medicine for CD – will evaluate individual risk for developing complications and help support personalized clinical decision-making

Takeda Pharmaceuticals U.S.A. [TSE:4502/NYSE:TAK]  (“Takeda”) and MiTest Health LLC (“MiTest”), a pioneering health technology company, today announced an exclusive partnership to optimize MiTest’s personalized risk and outcome prediction tool for widespread use in patients with Crohn’s disease (CD). The validated tool can help predict a patient’s individual potential risk for CD-related complications based on clinical, serologic and genetic variables and create a visual report to support informed, shared decision-making with their healthcare providers.[i]

Devastating complications from CD - such as fistulas, abscesses, strictures, and intestinal obstruction - can be common, yet the course of CD is highly variable and difficult to predict.[ii],[iii],[iv] Prognostic tools that can identify the potential risk for complication early are essential when considering the most appropriate management approach for an individual patient.[ii] With the goal of advancing personalized treatment in CD, Takeda and MiTest Health plan to make the validated predictive tool readily available for use by gastroenterologists to enhance informed clinical decision-making.[i]

“Crohn’s disease can cause severe complications and irreversible damage to the bowels. The tool has the potential to help tailor the approach for patients with Crohn’s disease by better informing them and their physicians about their individual potential risks for developing complications early on, before disease complications occur,” said Corey Siegel, MD, MS, MiTest co-founder, section chief of gastroenterology and hepatology and co-director of the IBD Center at the Dartmouth-Hitchcock Medical Center, NH. “The tool will help initiate conversation around potential disease progression and options based on predicted outcomes.”

“Physicians using the validated predictive tool will be better able to support their patients with Crohn’s disease, who face significant challenges, by developing a disease management plan based on a shared understanding of their individual prognosis,” said Marla Dubinsky, MD, MiTest co-founder, chief of pediatric gastroenterology and nutrition, co-director of the Susan and Leonard Feinstein IBD Clinical Center at Icahn School of Medicine at Mount Sinai in New York. “We look forward to our continued work with Takeda to bring this important resource to physicians and patients.”

This tool predicts an individual’s potential risk for disease progression before he or she develops severe complications using a blood sample that is analyzed for patient-specific serologic markers and NOD2 status, combined with clinical phenotype information. Based on the results, the tool will create a patient-friendly graphical risk score. Health care providers will then receive a report that can facilitate discussions with patients to determine an appropriate course of action.

“Takeda is dedicated to shaping the future of gastroenterology, and we are excited to help advance the use of personalized treatment in Crohn’s disease. By bringing a deep understanding of unmet clinical needs to our collaborations with strategic partners, we’re focused on delivering original and meaningful tools to support patients through their journey,” said Uthra Sundaram, Senior Vice President, GI Business Unit, Takeda Pharmaceuticals U.S.A., Inc. “In partnership with MiTest Health, Takeda looks forward to broadening the use of this tool, allowing more patients and physicians to benefit from discussions and shared decision-making prompted from its insights.”

This validated predictive tool was developed by MiTest in 2014, has been validated via analysis of a well-characterized cohort of adult patients with CD and predictive modelling, and has been used on a limited basis in clinical settings to date.1 Takeda will provide support in scaling up and operationalizing the tool to more broadly support providers and patients.

 

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About Crohn’s Disease

Crohn’s disease (CD) is of the most common forms of inflammatory bowel disease (IBD).[v] It is a chronic, relapsing, remitting, inflammatory condition of the gastrointestinal (GI) tract that is often progressive in nature.[vi] CD can affect any part of the GI tract from mouth to anus, and can affect the entire thickness of the bowel wall.[vii] CD commonly presents with symptoms of abdominal pain, diarrhea, and weight loss.[vi] The cause of CD is not fully understood; however, recent research suggests hereditary, genetics, environmental factors, and/or an abnormal immune response to microbial antigens in genetically predisposed individuals can lead to CD.[viii],[ix]

 

Takeda’s Commitment to Gastroenterology

Gastrointestinal (GI) diseases can be complex, debilitating and life-changing. Recognizing this unmet need, Takeda and our collaboration partners have focused on improving the lives of patients through the delivery of innovative medicines and dedicated patient disease support programs for more than 25 years. Takeda aspires to advance how patients manage their disease. Additionally, Takeda is leading in areas of gastroenterology associated with high unmet need, such as inflammatory bowel disease, short bowel syndrome, acid-related diseases and motility disorders. Our GI Research & Development team is also exploring solutions in celiac disease and liver diseases, as well as scientific advancements through microbiome therapies.

 

About Takeda Pharmaceuticals U.S.A.

Takeda has maintained a strong and growing commitment to the United States for more than 50 years. On January 8, 2019, Takeda completed its acquisition of Shire, PLC, becoming a global, values-based, R&D-driven biopharmaceutical leader. In the U.S., Takeda employs more than 18,000 employees across multiple business units, and as of August 2019, is headquartered out of the greater Boston area.

Additionally, Takeda also has a research facility in San Diego, California, specialty products manufacturing facilities in Brooklyn Park, Minnesota and plasma fractionation manufacturing facilities in Covington, Georgia.

As one of the world’s leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating science into life-changing medicines to the next level, in our core focus areas; oncology, gastroenterology, neuroscience, rare diseases, plasma-derived therapies, and vaccines.

 

About MiTest Health

MiTest Health, LLC is a biotechnology company focused on creating computer-based tools to be used to predict outcomes of patients with chronic diseases. Using a combination of clinical data, serologic and genetic markers, content expertise and advanced statistical techniques, computer models are developed to show patients and providers expected disease outcomes to facilitate shared decision making. MiTest Health’s first product is a personalized risk and outcome prediction tool for Crohn’s disease; other models for patients with inflammatory bowel disease and other disease states are under development.

 

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

 

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takeda’s estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s), any of which may cause Takeda’s actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takeda’s results, performance, achievements, or financial position, see “Item 3. Key Information—D. Risk Factors” in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov. Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takeda’s future results.

 

Media contacts:                            

For U.S. media

Amy McCarthy
+1 781-496-7761

Amy.McCarthy@Takeda.com

 

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References

[i] Siegel, C, Horton, H, Siegel, L, et al. A validated web‐based tool to display individualised Crohn's disease predicted outcomes based on clinical, serologic and genetic variables. Aliment Pharmacol Ther. 2016;43:262-271.

[ii] Mazor Y, Maza I, Kaufman E, Ben-Horin S, Karban A, Chowers Y, Eliakim R. Prediction of disease complication occurrence in Crohn’s disease using phenotype and genotype parameters at diagnosis. Journal of Crohn’s and Colitis. 2011;5:6:592-597.

[iii] Definitions and Facts for Crohn’s Disease. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases Web site: https://www.niddk.nih.gov/health-information/digestive-diseases/crohns-disease/definition-facts. Published September 2017. Accessed July 3, 2019.

[iv] Veloso FT. Clinical predictors of Crohn's disease course. Eur J Gastroenterol Hepatol. 2016 Oct;28(10):1122-5.

[v] Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007;369:1627-1640.

[vi] Baumgart DC, Sandborn WJ. Crohn’s disease. Lancet. 2012;380:1590-1605.

[vii] Feuerstein JD, Cheifetz AS. Crohn’s disease: Epidemiology, diagnosis and management. Mayo Clin Proc. 2017;92:1088-1103.

[viii] Henckaerts L, Pierik M, Joossens M, et al. Mutations in pattern recognition receptor genes modulate seroreactivity to microbial antigens in patients with inflammatory bowel disease. Gut. 2007;56:1536-1542.

[ix] Kaser A, Zeissig S, Blumberg RS. Genes and environment: How will our concepts on the pathophysiology of IBD develop in the future? Dig Dis. 2010;28:395-405.