Peptron said Monday that it has received phase 3 IND approval from the U.S. FDA for its proprietary ultrasonic spray drying SmartDepot technology as a cerebrovascular therapeutic, Presedin (PT320), being co-developed with Invex.

PT320 implements an ideal drug release pattern for therapeutic effects among glucagon-like peptide-1 (GLP-1) thanks to its development with the SmartDepot peptide platform. Following nods from the U.K., Canada, and Australia, it has now obtained U.S. regulator’s approval, demonstrating its competitiveness in the global market, the company said.

Samsung Bioepis' biosimilar product is the only subcutaneous (SC) injection produced in Korea and entered the U.S. market.

Only a few other candidate pipelines, such as Hanmi Pharmaceutical's LAPSCOVERY technology, Celltrion's Remsima SC formulation, and Dong-A ST's biosimilar, are under development after winning the FDA’s nod, Peptron added.

SmartDepot extends the efficacy of frequently injected peptide drugs once a week to once every six months due to a short half-life. It is particularly effective in developing brain disease treatments by increasing the permeability of blood brain barriers (BBB).

For PT320, Invex signed a joint development and exclusive supply contract with Peptron last year. In addition, Invex is conducting phase 3 global clinical trials of PT320 at 40 institutions internationally. With this approval, clinical patient recruitment and administration will begin in the U.S. in the second half-year.

"Peptron produces finished drugs with its technology at its GMP plant,” a company official said. “This approval proves that our SmartDepot technology and GMP production facilities can produce injections with global recognition."

If the company passes the next item licensing stage, it will leap from R&D to mass production and strive to become a Korean pharmaceutical company with global competitiveness, the official added.

Peptron is conducting a phase 2 clinical trial of a Parkinson’s disease treatment in Korea with PT320 and plans a clinical trial for Alzheimer's. Additionally, it is developing the world's first one-month sustainable treatment of peptide diabetes treatments, according to Peptron.

As the FDA approval allows PT320 to enter phase 3 immediately in the U.S., it is expected to gain great momentum in global clinical drug development and technology transfer, it added.