London, December 8, 2025 - Pangea Bio, a biotechnology company developing transformative therapies for neurological and mental health disorders, has received Clinical Trial Authorization (CTA) from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the Phase 1 clinical trial of its lead candidate, OT-003.

OT-003 is an orally bioavailable, selective TrkB activator designed to enhance neuroplasticity by directly activating the TrkB receptor, promoting neuronal and synaptic plasticity as well as neuroprotection. Dysregulation of the BDNF/TrkB pathway is implicated in several major diseases, including schizophrenia, depression, Alzheimer’s disease, Parkinson’s disease, and glaucoma. In preclinical studies, OT-003 has shown robust efficacy and signs of disease-modifying potential across multiple disease models. The MHRA’s approval marks an important step toward addressing the substantial and growing unmet needs in neurological and mental health disorders.

Lars Wilde, Pangea Bio’s CEO, said:

“The CTA approval is a critical milestone as we officially become a clinical-stage company. OT-003 holds strong potential to provide transformative medicines for people affected by neurological and mental health conditions, where the need for new treatments remains extraordinarily high.”

About Pangea Bio:

Pangea Bio is developing novel therapies that directly activate the TrkB receptor, driving neuronal and synaptic plasticity, and neuroprotection. Their lead candidate, OT-003, is an orally bioavailable, selective TrkB activator that delivers neuroplastic benefits. Pangea Bio is also advancing a pipeline of next-generation TrkB activators (OT-1xx) with broad potential across neurological and neuropsychiatric diseases.

Pangea Bio is backed by the Michael J. Fox Foundation, Alzheimer’s Drug Discovery Foundation, OneMind, and Innovate UK, and is seeking additional funding and partners.

For more information, please contact info@pangeabio.com