Mage Biologics (“Mage”) announces it has dosed the first study participant in a first-in-human study of MB-001, a best-in-class orally administered antibody designed for the treatment of inflammatory bowel disease (IBD).

The trial is a randomized, double-blind Phase 1 study to assess the safety and pharmacokinetics of single and multiple ascending doses of MB-001 in adult healthy volunteers (NCT06363383). Mage plans to complete the study in the first half of 2025.

Johannes Spleiss, CEO of Mage, commented: “We are excited to have been able to move MB-001 into the clinic in a very short period of time and are grateful for the strong support of the experienced Tillotts team that enabled us to quickly produce GMP-grade material for this novel delayed- and sustained-release formulation. Despite more options today for patients with IBD, there still remains a need for safe and highly effective treatments, particularly for the elderly.  MB-001 offers the potential to be such an option either as a stand-alone therapy or in combination with current treatments.”

Alimentiv, a specialty GI-focused Clinical Research Organization (CRO) specialized in clinical trial delivery, medical imaging solutions and precision medicine services, provided an excellent project team with deep gastrointestinal expertise that seamlessly integrated into our newly created organization.

Mage Biologics also engages with Chorus, a full-service autonomous research and development unit within Eli Lilly and Company, to support an innovative clinical plan in collaboration with an international network of ulcerative colitis experts.

About ulcerative colitis

Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that impacts millions of people worldwide. Ulcerative colitis affects the innermost lining of the colon and the rectum, causing inflammation and ulcers in the digestive tract. In most people, symptoms usually develop over time, taking a relapsing-remitting course, which means that periods of flare-ups are followed by periods of remission. This can be draining and, in some cases, lead to life-threatening complications. While there is no known cure, current treatments aim to reduce signs and symptoms of the disease and bring remission. Over the last decade, biologics have gained an important place in the treatment of ulcerative colitis, with several monoclonal antibodies available as subcutaneous or intravenous therapies approved for use in UC. Unfortunately, a substantial proportion of patients do not respond, lose response, or develop intolerance to currently marketed products, leading to a substantial unmet medical need for safer, effective, and more convenient therapeutic options.

About MB-001

MB-001 is a best-in-class orally administered, humanized antibody formulation designed for targeted release in the inflamed mucosa, optimal tissue penetration by active receptor-mediated transport, improved potency compared to systemically applied antibodies and optimized receptor interaction by a modified glycosylation pattern. The drug was designed to exert its action in the inflamed tissue with minimal systemic uptake.

About Mage Biologics Inc.

Mage Biologics is a special purpose company created to develop a novel, orally administered monoclonal antibody to clinical proof of concept for the treatment of ulcerative colitis. Mage Biologics is jointly funded by TVM Life Science Innovation II and Tillotts Pharma and is led by an experienced management team.

About Tillotts Pharma

Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with close to 400 employees in Switzerland and abroad. Tillotts is dedicated to the development, acquisition and commercialization of innovative pharmaceutical products for the digestive system. Tillotts successfully markets its own products for the treatment of IBD and Clostridioides difficile infection (CDI) as well as in-licensed products in around 65 countries through its affiliates within Europe and a network of partners throughout the world.

About TVM Capital Life Science

TVM is a leading international venture capital firm focused on investing in life science innovations.  The company has a highly experienced transatlantic investment team and approximately $900 million under management. TVM’s portfolio focuses on therapeutics and medical technologies from North America and the EU that represent differentiated first-in-class or best-in-class assets with the potential to transform standard of care.

TVM pursues a unique two-pronged strategy, financing innovative early-stage therapeutics through a single asset company approach (Project-Focused Company, PFC) that leverages the firm’s strategic relationship with global pharmaceutical firm, Eli Lilly and Company. TVM also invests in differentiated commercial-stage medical technologies and late clinical-stage therapeutics.

The TVM investment team has worked together for over a decade to effectively utilize this innovative approach to maximize returns for investors and finance new therapies and technologies to meaningfully improve patient lives.