Actinogen Medical's MHRA approval for Xanamem in Alzheimer's treatment

Actinogen Medical (ASX: $ACW) has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its application for an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for Xanamem in the treatment of Alzheimer's disease. This approval serves as an entry point to the ILAP, aiming to accelerate the time to market for Xanamem, and establishes linkage to a portfolio of activities through the product-specific creation of the Target Development Profile (TDP) in conjunction with the MHRA. Dr. Steven Gourlay, Actinogen's CEO and MD, expressed confidence in Xanamem's unique and encouraging profile for the treatment of Alzheimer's disease, following the MHRA's approval of the ILAP application. The company's 220-person phase 2b trial in Alzheimer's is currently underway and is expected to report initial results in the first half of 2025.

Dr. Steven Gourlay on MHRA approval and Xanamem's potential

The MHRA's approval of the ILAP application is a significant milestone for Actinogen Medical and validates our belief in Xanamem's unique and encouraging profile for the treatment of Alzheimer's disease. We are pleased with the progress of our 220-person phase 2b trial in Alzheimer's, and we anticipate reporting initial results as early as the first half of 2025. This approval paves the way for the development of the Target Development Profile (TDP) and opens up opportunities for enhanced regulatory and stakeholder input, which will be invaluable as we continue to advance Xanamem's potential in addressing the substantial unmet medical need for new and improved treatments in Alzheimer's disease.

MHRA approval and future outlook for Actinogen Medical

Actinogen Medical's approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for an Innovation Passport as part of the Innovative Licensing and Access Pathway (ILAP) for Xanamem in the treatment of Alzheimer's disease marks a significant advancement in the company's pursuit of addressing the substantial unmet medical need for new and improved treatments in Alzheimer's disease. The approval serves as an entry point to the ILAP, aiming to accelerate the time to market for Xanamem, and establishes linkage to a portfolio of activities through the product-specific creation of the Target Development Profile (TDP) in conjunction with the MHRA. Dr. Steven Gourlay, Actinogen's CEO and MD, expressed confidence in Xanamem's unique and encouraging profile for the treatment of Alzheimer's disease, following the MHRA's approval of the ILAP application. The company's 220-person phase 2b trial in Alzheimer's is currently underway and is expected to report initial results in the first half of 2025. Actinogen Medical's future outlook involves the commencement of the TDP development and the exploration of opportunities for enhanced regulatory and stakeholder input, positioning the company to make further strides in addressing the unmet medical needs in Alzheimer's disease.