Mage Biologics begins Phase 1 trial dosing of MB-001 for Inflammatory Bowel Disease

Mage Biologics has launched a significant clinical trial initiative in Newark, DE, USA. On June 12, 2024, the company announced it had administered the first dose of MB-001 to a study participant. MB-001 is a cutting-edge orally administered antibody specifically designed to treat inflammatory bowel disease (IBD).

The clinical trial, registered under NCT06363383, is a randomized, double-blind Phase 1 study focusing on the safety and pharmacokinetics of MB-001. The trial will involve single and multiple ascending doses administered to adult healthy volunteers. Mage Biologics aims to complete this study by mid-2025.

Johannes Spleiss, the CEO of Mage Biologics, expressed enthusiasm about the rapid progress of MB-001 into the clinical phase. He acknowledged the strong support from the experienced team at Tillotts Pharma, which facilitated the swift production of GMP-grade material for this novel formulation. Spleiss highlighted the ongoing need for safer and more effective treatments for IBD, particularly for elderly patients. He believes MB-001 has the potential to meet this need, either as a standalone therapy or in conjunction with existing treatments.

Alimentiv, a clinical research organization specializing in gastrointestinal trials, has provided a specialized project team to assist with the trial. This team brings deep expertise in gastrointestinal studies, integrating seamlessly with Mage Biologics' newly established operations.

Mage Biologics is also collaborating with Chorus, an autonomous research and development unit within Eli Lilly and Company. This partnership supports an innovative clinical plan in conjunction with an international network of ulcerative colitis (UC) experts.

Ulcerative colitis is a chronic inflammatory bowel disease that affects millions globally. It causes inflammation and ulcers in the colon and rectum, leading to symptoms that develop gradually and often follow a relapsing-remitting course. This condition can be debilitating and may result in severe complications. While there is no cure, current treatments aim to reduce symptoms and induce remission. Over the past decade, biologics have become essential in UC treatment, with several monoclonal antibodies available for subcutaneous or intravenous use. However, many patients do not respond adequately or develop intolerance, highlighting the need for more effective and convenient treatments.

MB-001 stands out as a premier oral antibody formulation designed for targeted release in inflamed mucosa. It ensures optimal tissue penetration through active receptor-mediated transport while offering improved potency over systemically applied antibodies. The drug's design enables it to act primarily in inflamed tissue with minimal systemic absorption.

Mage Biologics is a specialized company focused on developing this novel oral monoclonal antibody for UC treatment. The company benefits from joint funding by TVM Life Science Innovation II and Tillotts Pharma and is led by a seasoned management team.

Tillotts Pharma AG, part of the Japanese Zeria Group, is a rapidly growing specialty pharma company with around 400 employees. The company is committed to developing, acquiring, and commercializing innovative digestive system treatments. Tillotts markets its products for IBD and Clostridioides difficile infection (CDI) in approximately 65 countries through its European affiliates and global partners.

TVM Capital Life Science is an international venture capital firm investing in life sciences innovations. With a portfolio focusing on therapeutics and medical technologies from North America and Europe, TVM aims to transform standard care. The firm uses a unique strategy to finance early-stage therapeutics through single asset companies, leveraging a strategic relationship with Eli Lilly. TVM also invests in commercial-stage medical technologies and late clinical-stage therapeutics.