HLB BioStep Supports IND Approval of Parkinson's Drug with Integrated Non-Clinical Services

HLB BioStep announced that the Parkinson's disease treatment candidate 'YPD-01', for which it provided integrated non-clinical services to facilitate clinical entry, has received approval for a Phase 1 clinical trial investigational new drug (IND) application from the Ministry of Food and Drug Safety.

According to HLB BioStep on July 16, the company, together with its subsidiary HLB BioCode, performed the integrated IND package service for the non-clinical studies of Yebbio's Parkinson's disease treatment candidate 'YPD-01', following the domestic Phase 1 IND approval granted to Yebbio on July 10.

'YPD-01' is the world's first oral disease-modifying therapy (DMT) candidate targeting PARIS (ZNF746), a protein involved in the onset and progression of Parkinson's disease, with the aim of delaying disease progression.

HLB BioStep provided key pharmacokinetic (PK) data necessary for the clinical trial design through PK studies, while HLB BioCode conducted major non-clinical safety evaluation studies required for IND submission, including single and repeated dose toxicity tests, genotoxicity tests, and safety pharmacology studies in compliance with GLP standards.

The company has established an integrated non-clinical service encompassing PK, toxicity, and safety assessment, and recently completed a new drug development platform that supports the entire process from non-clinical to clinical stages in a one-stop manner through collaboration with clinical CROs.

Yebbio, based on the expertise confirmed through this IND approval process with HLB BioStep and HLB BioCode, has also decided to promote additional non-clinical studies needed to enter Phase 2 clinical trials in parallel with Phase 1 trials.

Seongjun Kim, CEO of Yebbio, stated, "Thanks to the systematic support and expertise provided by HLB BioStep and HLB BioCode from non-clinical development to IND submission, we were able to successfully pass the first milestone for clinical entry."

Seongjin Baek, CEO of HLB BioStep, said, "The approval of this IND once again proves the competitiveness of the integrated non-clinical service model built by HLB BioStep and HLB BioCode. By further collaborating with clinical CROs, we plan to expand our partnerships with domestic and overseas clients based on our platform that supports the entire drug development lifecycle."

This content was produced with the assistance of AI translation services.