Alera Bio Takes Bold Step Toward First Treatment for MCT-8 Deficiency with AB-101 Program

Alera Bio Takes Bold Step Toward First Treatment for MCT-8 Deficiency with AB-101 Program

Alera Bio, a Chicago-based biotech company dedicated to rare neurological diseases, has announced a significant breakthrough in the quest to treat MCT-8 deficiency, otherwise known as Allan-Herndon-Dudley Syndrome. On September 18, 2025, the company revealed it has secured exclusive rights from BLA Technology, LLC on PR.com to develop therapies addressing this devastating genetic disorder. This exclusive license covers intellectual property that forms the foundation of Alera Bio’s flagship program, AB-101.

MCT-8 deficiency is an extremely rare inherited disorder, affecting about one in 70,000 males worldwide. Most cases are identified in early childhood and present with severe developmental delays, impaired movement, cognitive difficulties, and complex thyroid issues. To date, there are no approved therapies for this condition, leaving patients and families with few options.

AB-101 is designed to break new ground as the first potential therapy to address both the neurological and hormonal symptoms characteristic of MCT-8 deficiency. The program has already been granted Rare Pediatric Disease (RPD) designation by the U.S. Food and Drug Administration (FDA), which could pave the way for faster development and review.

Frank Jaeger, founder and chair of Alera Bio, highlighted the significance of this milestone: “AB-101 represents our commitment to tackling diseases with no available treatments, aiming to improve both brain and body functions affected by MCT-8 deficiency. This exclusive agreement gives us the momentum to bring much-needed hope to patients and their families.”

BLA Technology’s Managing Director, Cassius Coleman, expressed confidence in the partnership, noting that Alera Bio’s focus and resources offer the best chance for AB-101 to reach those in need: “We’re excited to see this important therapy prioritized and advanced by a team dedicated to rare disease innovation.”

Alera Bio’s next steps include pursuing Orphan Drug status for AB-101, which would bring additional regulatory incentives and support. The company aims to start preclinical research by the end of 2025, with plans to move into patient trials in 2026.

Established in 2025, Alera Bio operates with a patient-centered approach, leveraging modern science and efficient development strategies to target rare neurological conditions. The company’s guiding principle, “Biology drives us. Patients define us,” captures its determination to make a difference where current medicine falls short.

Through its collaboration with BLA Technology, whose patent portfolio spans a range of thyroid-related conditions, Alera Bio is positioned at the forefront of developing the first treatment for MCT-8 deficiency. The launch of the AB-101 program marks a hopeful new chapter for patients, families, and the broader rare disease community.