Peptron's Smartdepo Technology Drug Receives First US FDA Phase 3 Clinical Trial Approval

[Asia Economy Reporter Lee Gwan-joo] Peptron announced on the 22nd that it has received approval from the U.S. Food and Drug Administration (FDA) for the first Phase 3 clinical trial application (IND) of its cerebrovascular treatment drug "Prisendin," which is being jointly developed with Invex, using smart depot technology.

Prisendin is a sustained-release subcutaneous injection (SC) formulation developed with Peptron's peptide platform technology, smart depot technology. This year, it has passed the FDA gateway following approvals in the UK, Canada, and Australia.

Smart depot technology extends the efficacy duration of peptide drugs, which typically have a short half-life and require frequent injections, enabling dosing from once a week to once every six months. It is particularly effective in developing treatments for brain diseases by increasing the permeability of the blood-brain barrier (BBB).

Invex signed a joint development and exclusive supply agreement with Peptron last year and is currently conducting global Phase 3 clinical trials of Prisendin at 40 institutions worldwide. With this approval, patient recruitment and administration in the U.S. are expected to begin in the second half of the year.

A Peptron representative stated, "The FDA IND approval, which allows the first export of clinical trial drugs to the U.S., signifies that Peptron's smart depot technology and GMP manufacturing facilities capable of producing finished injectable drugs have been recognized globally."