On World IBD Day Biotech Companies Continue to Develop IBD Treatments


Severe diarrhea. Bloody stool. Abdominal pain. Fatigue. Reduced appetite. Weight loss. These are the general symptoms of chronic inflammatory diseases of the digestive tract grouped under the term inflammatory bowel disease.

On May 19 every year the people who are afflicted with these disorders unite across the globe to raise awareness of the disease and urge governments and healthcare systems to continue to focus on the development of necessary treatments for the various diseases that fall under the IBD umbrella, such as Crohn’s disease and ulcerative colitis, the two most common forms of the disease. Globally, there are more than 5 million people afflicted with one of these diseases and currently, there is no cure. Despite the millions of patients afflicted, the cause of ulcerative colitis and Crohn’s disease is not fully understood.

There are a number of treatment options used by physicians to treat IBD, including anti-inflammatory drugs, antibiotics and immunosuppressants. While the causes of the two most common IBDs are not understood, companies across the biotech spectrum spend millions of dollars working to develop therapies to help treat the issue. This week the California-based Kenneth Rainin Foundation announced it was accepting proposals for grant awards for cross-disciplinary research collaborations to study IBD.

Takeda Pharmaceuticals has a long history of working in the IBD arena. The company has a program called IBD Unmasked that seeks to lift the mask of IBD and put a face on those seeking treatment. Last year the company teamed up with Marvel Custom Solutions, a division of the comics giant, to develop The Unbeatables, a graphic novel featuring five superheroes who either have IBD or are taking care of family members with the disease. The story follows the characters who overcome their own IBD challenges to protect the global community from the threat of a super villain known as Technonaut.

In January, Takeda Pharmaceuticals launched a study to understand how IBD patients seek treatment. The study analyzed the patients’ use of social media to understand what factors influence how the patients seek treatment. The survey results prompted the development of an online tool called IBD&me that generates personalized discussion guides for patients to support shared decision-making when discussing treatment options with their provider. With funding from Takeda, the IBD&me tool was made publicly available for any patient with IBD to use by Cedars-Sinai. The IBD&me tool uses a series of questions to gauge patients about their therapeutic preferences. The questions seek to gain information as to what they prefer, from the method of delivery to the efficacy and safety profile and time between doses, Takeda said. The patients then receive a personalized report clearly outlining treatment factors they consider most important, which can be used in discussions with their physicians as they evaluate options, the company added.

Earlier this year Janssen Pharmaceuticals and its parent company Johnson & Johnson forked over $100 million to Theravance as part of a collaborative deal to develop a treatment for inflammatory bowel diseases. The companies are teaming up to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor. Irritable Bowel Disease (IBD) includes Crohn’s disease and ulcerative colitis (UC). The companies are likely looking at developing a new treatment to replace a standard of treatment, Remicade, which lost patent protection.

One challenger to Remicade is Inflectra, a biosimilar developed by Celltrion and Pfizer. Inflectra is a treatment indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and adult and pediatric Crohn’s disease.

Last year J&J teamed up with Protagonist Therapeutics in a deal worth up to $1 billion to develop Protagonist's first-in-class, oral peptide Interleukin-23 receptor antagonist. The oral drug is designed to offer significant advantages over injectable antibody drugs, in the treatment of IBD. Protagonist’s PTG-100 was in a Phase IIb study for ulcerative colitis that was discontinued earlier this year following a review from an Independent Data Monitoring Committee. Protagonist’s PTG-200 for Crohn’s is expected to begin a Phase II study later this year.

One company, Israel-based Protalix Biotherapeutics, is developing a treatment for ulcerative colitis that could potentially replace current TNF-inhibitor therapies that are administered via injection or infusion. In March Protalix announced positive Phase II results for OPRX-106, a plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). The medication is designed to be delivered orally. When it is passing through the digestive tract the company said the plant cells in OPRX-106 function as a natural delivery vehicle. The investigational treatment is biologically active in the gut without triggering the formation of anti-drug antibodies, which is an issue with current TNF-inhibitors.

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