Daewoong Pharmaceutical said on Tuesday that it has completed a phase 1 clinical trial of IVL3001(ingredient name: finasteride), a hair loss treatment injection, in Australia in collaboration with Inventage Lab and Withus Pharmaceutical.
The first phase of the IVL3001 clinical trial proved stable blood drug concentration, dihydrotestosterone (DHT) concentration suppression, and excellent drug resistance through a review of drug dynamics and drug resistance. Additionally, the results contained some clinical phase 2 elements, such as optimal dose comparison, welcoming the possibility of directly entering phase 3 clinical trials.
IVL3001 was exposed to a constant concentration in the blood for more than a month without undergoing any initial burst, the biggest risk of conventional long-term injections. The initial hyper release phenomenon, in which the blood drug concentration rises rapidly immediately after administration, must be managed to avoid potential side effects. Excessive release over a short period immediately after administration can cause physical and psychological burdens on long-term injections in patients.
Furthermore, the clinical trial proved that the IVL3001 injection maintained the blood DHT concentration, an indicator of hair loss treatment, at the same low level as oral drugs.
Also, drug compliance is important when taking oral drugs. Still, long-lasting injections can guarantee the convenience of not having to take oral drugs daily, without the risk of misuse and side effects, according to Daewoong.
The three companies plan to develop and commercialize IVL3001 in Korea next year jointly. Daewoong Pharmaceutical will carry out phase 3 clinical trials, licensing, and sales, Inventage Lab will conduct pre-clinical and clinical phase 1 trial and production support, and Withus Pharmaceutical will manufacture the product.
"We are pleased to show the value of IVL3001 based on microfluidic technologies,” Inventage Lab CEO Kim Ju-hee said, “We will do our best to shorten the commercialization period through active cooperation with our partners for successful product development.
Daewoong CEO Jeon Seung-ho said, "We will quickly complete the follow-up development process to prove that products and technologies are of high commercial value."
Jeon added that the success of the Australian clinical trial is the world's first human verification result of long-lasting injections for hair loss treatment.