Biology drives us.
Patients define us.
At Alera Bio, we are dedicated to developing breakthrough therapies for neurological conditions that profoundly impact patients’ lives. Our work is driven by science, compassion, and an unwavering commitment to those in need.
Our Mission
Our mission is to develop transformative therapies for rare diseases that improve the lives of patients suffering from neurological deficits.
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Alera Bio is committed to bringing innovative therapies to the patients who need them. We believe that the answer to solving chronic conditions is not "never" but rather "not yet".
We are united in a shared vision to identify and bring products to address the frustrations that clinicians have, debilitation that patients experience, the sadness that caregivers feel, and the costs that it costs society. We are champions in the pursuit of scientific excellence and the importance of the scientific method. We are bold and challenge each other so that we can restore hope to the community we serve.
Our Vision
We envision a future where patients no longer have to settle for limited options. Instead, they can look forward to treatments that empower them to live fuller, richer lives.​
What Drives Us?
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The thought that one day our treatments will help even just one patient.
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That all conditions are possible to be treated, we just haven’t discovered yet how to do that.
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By focusing on the patient, we will always do what’s right.
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Operating in a professional manner with the ethics and behavior that is expected of a biotech leader.
Our Values
We look for what’s possible
Innovation starts with curiosity and determination. We push boundaries, explore new possibilities, and never settle for the status quo.
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Strength comes from the team
Collaboration is at the heart of what we do. By bringing together scientists, clinicians, and advocates, we amplify our impact and move closer to life-changing breakthroughs.
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We walk the talk
We don’t just talk about making a difference – we take action. Integrity, accountability, and a relentless drive to help patients guide every decision we make.
"Biotechnology has the potential to be our time machine, propelling us into a future where patients with rare diseases can lead fulfilling lives."
Alera Bio
Our Strategy
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We are focused on developing our lead candidate AB-101 for the treatment of Allan-Herndon-Dudley Syndrome.
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We believe that AB-101 has the potential to become an important treatment that can help children who suffer from this condition and its devastating effects. We believe that our proprietary formulation may also help other patients suffering from other rare neurological conditions.
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Alera Bio owns the worldwide rights for development and commercialization for AB-101.
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In 2024, AB-101 was granted Rare Disease Designation by the FDA. With this designation, the company has the potential to receive a Priority Review Voucher (PRV) upon approval. PRV's have been sold to other companies for $100-$150 MM​. In addition to bringing AB-101 to the market, this could provide a significant infusion of resources for the company to continue to develop our pipeline.
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We are focused on accelerating the development of AB-101 and achieving several key milestones during 2025 and early 2026. They are:
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Orphan Drug Disease (ODD) Designation – With AB-101 already being granted Rare Pediatric Disease Designation with the FDA, the company intends to file for ODD. If granted, this could provide 7- and 12- years market exclusivity for the U.S. and Europe, respectively.
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Preclinical Proof of Concept – We intend to leverage our key learnings from the work our scientific founder has accomplished and demonstrate the safety, efficacy, dosing and MTD of our proprietary formulation.
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Engineered Product – By completing the appropriate product development work, the company will have a product ​​​that is ready for broader GMP stability and formulation studies.
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Pre-IND Meeting – Through the operational plan, the company intends to have a pre-IND meeting with the FDA and agree on the clinical path forward by the end of the year.​​​
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Investigational New Drug – By early 2026, the company believes that the product will be well characterized and able to move into clinical trials.​​
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Breakthrough Therapy Designation – We believe that AB-101 has the potential to address not only the endocrinological symptoms of MCT-8 deficiency but importantly the neurological consequences as well. ​​Our goal is to demonstrate this and receive this designation by the FDA in early 2026.
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