Aeglea administers 1st patient in AGLE-177 clinical trial for Homocystinuria

Aeglea BioTherapeutics, Inc., a company indulged in development of new generation of human enzyme therapeutics for rare metabolic diseases, recently announced administering the first patient in its first-in-human Phase 1/2 clinical trial of AGLE-177 for Homocystinuria treatment.

For the record, AGLE-177 is an engineered human enzyme therapy created to reduce the total level of homocysteine in the plasma. Meanwhile, the company anticipates offering a clinical update on the program prior to the end of 2021.

According to reliable sources, the Phase 1/2 trial is projected to register 16-20 patients detected with Homocystinuria aged above 12 years at facilities in Australia and the United Kingdom. The primary endpoint is the tolerability and safety of AGLE-177. Secondary endpoints consist of pharmacokinetic evaluations as well as reduction in plasma total homocysteine levels.

Reports suggest that the patients would be dosed weekly for four weeks, with four patients in each of four dosing group and an option to include the fifth group if required.

Commenting on the latest accomplishment, President and CEO of Aeglea, Anthony Quinn, M.B Ch.B, Ph.D, cited that AGLE-177 is built to address the increased homocysteine levels that are thought to be a fundamental driver of the risk of severe complications in Homocystinuria.

The firm believes that the clinical trial would potentially provide it with proof of concept of the homocysteine reducing effects of AGLE-177 in patients. Moreover, it is also anticipated to offer the company with required information to pivot rapidly to a Phase 3 registrational trial.

On the other hand, Dr. Elaine Murphy, Principal Investigator at Charles Dent Metabolic Unit, National Hospital for Neurology and Neurosurgery, London, stated that untreated homocystinuria emerges out to be a critical disease as a result of which patients are likely to develop significant complications, including skeletal abnormalities, visual impairment, recurrent thromboembolic events, and reduced intellectual capacity, which can be fatal.

This eventually makes way for the clinical trial of AGLE-177 for critically ill patients. Murphy believes that this evaluation would pave way for a potential treatment for Homocystinuria.

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