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- FDA Approves Wezlana, Inotrem receives milestone funding from C & C Foundation, Inverse vaccine
FDA Approves Wezlana, Inotrem receives milestone funding from C & C Foundation, Inverse vaccine
IBD Newsletter
2023-11-07
Welcome to the second week of the IBD Newsletter. Below, you can find some recent news from the IBD world. If you have any questions or feedback, do not hesitate to contact us by simply replying to this email.
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The FDA has approved Wezlana as a biosimilar and interchangeable medication to treat various inflammatory diseases, including psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis in adults and children. Biosimilars are highly similar to existing biological drugs and can be substituted at pharmacies. This approval aims to increase access to effective treatments at potentially lower costs, maintaining rigorous safety and efficacy standards. Wezlana's most serious side effect is infection, and its labeling includes warnings about infection risks, malignancies, hypersensitivity reactions, and Posterior Reversible Encephalopathy Syndrome.
A recent Swedish medical study suggests that statins, known for lowering cholesterol, may also protect against colorectal cancer, especially in ulcerative colitis patients. The study, which analyzed over 10,500 irritable bowel disease patients, found a reduced risk of colorectal cancer and related deaths in the group using statins. The protective effect became apparent after two years of use and was more significant for ulcerative colitis patients. However, further research is needed to establish causality, dosage, and treatment duration.
Significant progress has been made in understanding and treating inflammatory bowel diseases (IBD) like ulcerative colitis and Crohn's disease. The International Organisation for the Study of Inflammatory Bowel Diseases (IOIBD) introduced the STRIDE program, outlining treatment goals. Current IBD treatments include immunomodulators and biologics, but many patients experience primary and secondary loss of response. New emerging therapies, including anti-TNFĪ± drugs, antiadhesion agents, cytokine inhibitors, JAK inhibitors, PDE inhibitors, S1PR modulators, and miR-124 upregulators, offer hope for those who haven't responded to previous treatments. While further research is needed, these therapies have the potential to revolutionize IBD treatment.
Inotrem, a biotech company, received additional funding from the American Crohn's & Colitis Foundation based on successful interim data supporting their approach targeting the TREM-1 pathway to treat chronic inflammatory conditions, specifically Inflammatory Bowel Disease (IBD). This funding follows an initial grant in December 2022 and will aid in the preparation of Inotrem's first-in-human clinical trial for their antibody program (INO-02). The company's innovative approach and strong scientific leadership have garnered support from the foundation, emphasizing their potential in addressing these inflammatory diseases.
Researchers from the University of Chicago have developed an "inverse" vaccine that shows promise in addressing autoimmune diseases, such as multiple sclerosis and type 1 diabetes. If successfully developed, this innovation could potentially benefit not only people with MS and T1D but also those with organ transplant complications and other disabling autoimmune disorders, including rheumatoid arthritis (RA), celiac disease, inflammatory bowel disease (IBD), lupus, and more. Unlike traditional vaccines that stimulate the immune system, inverse vaccines train the immune system to recognize healthy tissues and stop attacking them. The method involves using the liver to retrain the immune system by pairing self-antigens with friendly molecules. While the results are promising, the study has limitations, and the translation to human applications remains uncertain. The potential benefits include durable remission and reduced treatment costs, but challenges in development and clinical trials lie ahead.
Galapagos has agreed to sell the rights to its JAK inhibitor drug, Jyseleca, used for rheumatoid arthritis and ulcerative colitis therapy, to Italy's Alfasigma SpA. The deal is worth up to ā¬170 million, including a ā¬50 million upfront payment, potential milestones of ā¬120 million, and royalties on European sales. Alfasigma will take over marketing authorizations and employ approximately 400 Galapagos employees involved in Jyseleca activities. The drug faced setbacks, leading to the termination of Gilead Sciences' involvement. This deal contributes to Galapagos' cost-reduction efforts and adds to Alfasigma's international expansion plans.
Ulcerative colitis (UC) is a lifelong, incurable inflammatory bowel disease. Treatment options include medication and surgery. Remission of symptoms is possible, lasting weeks to years, with various treatments, including medication, diet, and lifestyle changes. Complementary therapies can also be considered, but it's essential to consult with a healthcare provider. Management involves identifying triggers, maintaining a healthy diet, managing stress, and regular exercise. Ongoing research is improving UC treatment options, offering hope for those living with the condition.
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