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Peptron announced Monday that it has received Phase 3 IND approval from the US FDA for its proprietary ultrasonic spray dryer SmartDepo Technology as a cerebrovascular therapeutic Precedin (PT320) in partnership with Invex.
PT320 utilizes the SmartDepot peptide platform to implement a drug release pattern optimized for therapeutic effects between glucagon-like peptide-1 (GLP-1). Following submissions from the UK, Canada and Australia, it has now received US regulatory approval, demonstrating its competitiveness in the global market, the company said.
Samsung’s Bioepis biosimilar product is the only subcutaneous (SC) injection manufactured in Korea and introduced into the US 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 in development after winning the FDA nod, Peptron added.
SmartDepot extends the effectiveness of peptide drugs that are frequently injected once weekly to once every six months due to their short half-life. It is particularly effective in developing brain disease treatments by increasing the permeability of the blood brain barrier (BBB).
For PT320, Invex signed a joint development and exclusive supply contract with Peptron last year. Additionally, Invex is conducting Phase 3 global clinical trials of PT320 at 40 facilities worldwide. With this approval, clinical patient recruitment and administration will begin in the US in the second half of the year.
“Peptron manufactures technologically advanced medicines at its GMP factory,” said a company official. “This approval confirms that our Smart Depot technology and our GMP manufacturing facilities can produce world-class certified syringes.”
If the company passes the next stage of unit licensing, it will strive to become a globally competitive Korean pharmaceutical company by jumping from R&D to mass production, the official added.
Peptron is conducting a Phase 2 clinical trial of PT320 for the treatment of Parkinson’s disease in Korea and plans a clinical trial for Alzheimer’s. It is also developing the world’s first one-month long-lasting peptide diabetes treatment, according to Peptron.
FDA approval is expected to allow PT320 to immediately enter Phase 3 in the US, which is expected to provide a major boost in global clinical drug development and technology transfer, he added.
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