Lemonex starts phase 1 clinical trials for gene therapy drug

Korean biotech company Lemonex said Wednesday that it will begin phase one clinical trials for its new siRNA gene therapy drug LEM-S401, following the approval of its investigational new drug application on April 15 by the Ministry of Food and Drug Safety.

siRNA drugs inject small-interfering RNA molecules to augment or inhibit disease-related genes. LEM-S401 is a siRNA drug used to treat and prevent thick scars.

The new drug is administered through DegradaBall, the company’s proprietary nanodrug delivery technology. This patented technology delivers drug materials precisely to cultured cells or localized lesions. The nanodrug delivery technology increases safety and therapeutic outcomes compared to preexisting method of injecting large amounts of siRNA without any drug delivery system, according to the company.

Phase one clinical trials will be performed on healthy participants to evaluate drug safety. Lemonex said it will use these trials as an opportunity to not only develop the siRNA drug, but to accelerate the development of dual-acting RNA immunotherapy drugs and DegradaBall administered mRNA vaccines.

The nanodrug delivery technology can potentially act as a safer alternative to the drug delivery system currently used to administer COVID-19 vaccines, said the biotech company.

It expressed hope that confirming the clinical safety of DegradaBall would satisfy increased global demand for safer gene therapy and mRNA vaccine options.

“DegradaBall is diversely applicable to siRNA, mRNA and cytokines,” Won Cheol-hee, chief executive officer of Lemonex, said. He added that Lemonex is planning on “a wide range of business programs such as research collaborations with various partners, changes in formulation and license-out.”

By Lee Seung-ku (seungku99@heraldcorp.com)