Peptron's Smartdepo Technology Drug Receives First FDA Phase 3 Approval... "Hope for Parkinson's and Alzheimer's Treatments"

[Asia Economy Reporter Hyungsoo Park] Peptron announced on the 22nd that it has received the first US FDA Phase 3 IND approval for its smart depot technology with the cerebrovascular treatment drug ‘Presendin’, which is being jointly developed with Invex.

Presendin is a sustained-release subcutaneous (SC) injection formulation drug developed using Peptron’s peptide platform technology, smart depot technology, with the pipeline name PT320. This year, following the UK, Canada, and Australia, it passed the world’s most prestigious US FDA gateway, proving the pride and competitiveness of domestic pharmaceutical technology and quality in the global market.

The only SC injection drug produced domestically and successfully launched in the US is Samsung Bioepis’s biosimilar product. After FDA Phase 3 approval, ongoing developments include Hanmi Pharmaceutical’s Lab Discovery technology, which is expected to receive new drug approval within the year, Celltrion’s Remsima SC formulation, and Dong-A ST’s biosimilars, among a few others.

Obtaining US clinical Phase 3 approval for Peptron’s smart depot technology in finished subcutaneous injection drugs, which require stringent approval and high-level technology, is an achievement that demonstrates global-level technological capability.

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

Invex decided to enter Presendin’s regulatory clinical trials with Peptron’s PT320, which implements the most ideal drug release pattern among GLP-1 drugs, and signed a joint development and exclusive supply contract with Peptron last year. Invex is conducting global Phase 3 clinical trials of Presendin at 40 institutions worldwide. Patient recruitment and administration in the US are scheduled to begin in the second half of this year.

A company official explained, "Peptron produces finished drugs using its own technology at a dedicated GMP factory in Osong," adding, "The FDA IND approval for clinical drugs marks the first US export approval and signifies that Peptron’s smart depot technology and GMP production facilities capable of manufacturing finished injectable drugs have been recognized worldwide."

He continued, "Once the product approval stage is passed, we will leap forward as a global company that handles everything from research and development to mass production," and added, "We will do our best to become a globally competitive Korean pharmaceutical bio company."

Peptron is conducting Phase 2 clinical trials for Parkinson’s disease in Korea with PT320 and is also planning clinical trials for Alzheimer’s disease. With this FDA approval, PT320 can directly enter Phase 3 in the US, which is expected to significantly accelerate global clinical development and technology transfer.

Additionally, Peptron is applying smart depot technology to GLP-1 peptide diabetes treatments, a market worth 15 trillion KRW, developing the world’s first one-month sustained-release treatment.