At Alera Bio, clinical trials are central to our mission of expanding treatment options for rare diseases like MCT-8 deficiency. Our focus is to initiate clinical trials that provide patients with access to innovative, cutting-edge therapies while ensuring compassionate, transparent care every step of the way.
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We are dedicated to designing clinical trials that prioritize patient safety, improve outcomes, and meet the rigorous standards required for FDA approval. Gaining regulatory approval is a journey – one that demands a diverse and inclusive approach to patient participation. This allows us to develop life-changing therapies for the broadest possible range of patients.
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Our commitment is clear: we hold ourselves to the highest standards in research and development. Bringing transformative treatments to patients requires unwavering hard work and dedication, and you have our pledge to bring that same level of commitment every day. We invite you to join us on this journey to make a meaningful difference in the lives of patients.
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Our lead investigational product for the treatment of MCT-8 deficiency is currently in preclinical development. We plan to enter clinical studies in 2026. As this product is not yet FDA-approved, its safety and efficacy in humans have not been established.