According to Microbiome Times, Ilya Pharma has received a BIO-X® grant to study gene therapy for patients with inflammatory bowel disease. Their chemokine-based gene therapy drug candidates seek to improve patient outcomes for IBD treatment. Read the entire release here.
About Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) refers to a group of conditions which cause inflammation throughout the digestive tract. These conditions include Crohn’s disease and ulcerative colitis. Patients with inflammatory bowel disease often experience diarrhea, weight loss, bloody stool, abdominal pain, and fatigue. However, symptom severity will depend on how much inflammation is present.
If you have inflammatory bowel disease and experience a sudden change in symptoms, or sudden onset of symptoms, please see a doctor as soon as possible. Inflammatory bowel disease is manageable. However, it can lead to complications such as blood clots and colon cancer.
Doctors are unclear on the exact cause of IBD. However, many believe that the immune system fails to function correctly, attacking the digestive tract while fighting viruses or bacteria. Learn more about inflammatory bowel disease on our website.
Ilya Pharma & Gene Therapy
Gene therapy is a burgeoning study within the medical field. It addresses diseases and disorders on a genetic level by stopping or altering the way that certain genes are read.
The BIO-X® Grant supports innovative companies within the life science and healthcare realms. Funding, support, and expertise are provided. BIO-X® grants are only given to projects which have already performed some studies and fill gaps in healthcare and patient needs. In this case, studies on safety, tolerability, and dosage have occurred.
For Ilya Pharma, this grant will cover the costs associated with pre-clinical trials for ILP100 and ILP101.
ILP100 and ILP101
Ilya Pharma, a Swedish biopharmaceutical company, aims to study the impact of chemokine-based gene therapy on patients with inflammatory bowel disease. The company’s cofounder shared that while the prevalence of IBD continues to increase, a large amount of patients are not responding well to treatments: 46% for Crohn’s disease and 25% for ulcerative colitis. Many of the treatments are biologics which suppress the immune system.
Additionally, these treatments are a heavy financial burden for patients at up to $22,987 annually. Thus, Ilya Pharma hopes that ILP100 and ILP101 will reduce the costs and side effects associated with current IBD treatments while also providing patient relief.
Importance of These New Therapeutics
ILP100 and ILP101 are genetically modified lactobacilli. When introduced to the body, these innovative therapeutics express chemokines CXCL12 and CXCL17. Previously, research has not explored chemokines as an option for gastrointestinal disorders. However, researchers found that giving mice models of IBD ILP100 via an oral dose stopped the progression of the disease. Further, it prevented additional weight loss and fibrosis, a formation of thick fibrous tissue or scarring.
These gene therapies were also found to address inflammation in the lamina propria (connective tissue) within the colon. However, ILP100 made no changes in mesenteric lymph nodes or the small intestine.
Researchers also found that ILP100 dosing increased immune function. Immune cells producing TGF-ß and interleukin 10 (IL-10) grew. According to Sino Biological, TGF-ß can influence immune health and prevent cell death. IL-10 is an anti-inflammatory cytokine that can suppress unhealthy immune responses. Other tolerogenic immune cells also increased; much like TGF-ß and IL-10, tolerogenic immune cells help the body build a tolerance against disagreeable immune responses.
This suggests that ILP100 and ILP101 have the ability to address specific and targeted areas of inflammation, making it a far-reaching treatment option for many patients. Additionally, these solutions can stimulate the growth and development of immune cells to reduce abnormal immune function.
As it stands now, ILP100 and ILP101 are considered investigational new products (IMP) that represent a new way to target inflammation and immune response for patients with inflammatory bowel disease. The gene therapies are called advanced therapy medicinal products by the European Medicines Agency and seen as “low risk” by the U.S. Food and Drug Administration.
Microbiome Times lists Ilya Pharma’s next steps as:
confirmatory studies, verification in human derived tissues, GLP-studies of pharmacokinetics, pharmacodynamics and toxicity,…adaptations to the final stages of the already GMP-compliant bioprocess.
The company hopes to participate in clinical trials on IBD by 2022.