CKD-Novartis new drug advances to the next phase trial

Novartis has submitted its Investigational New Drug (IND) application for HDAC6 inhibitor to the U.S. Food and Drug Administration (FDA)

CKD out-licensed with an upfront payment of USD 80 million in November 2023…Novartis enters the first next-phase clinical trial

CKD secures the first milestone payment of USD 5 million after out-licensing

Chong Kun Dang (CKD)'s new drug candidate out-licensed to Novartis is entering the next clinical stage.

 

CKD has secured its first milestone payment of KRW 7 billion, 1 year and 6 months after the technology export contract.

 

CKD announced on May 22 that it expects to receive a milestone payment of USD 5 million (KRW 7 billion) from Novartis, upon the achievement of a stage-based milestone for CKD-510.

 

As Novartis submitted its Investigational New Drug (IND) application for a Phase 2 clinical trial of CKD-510 to the U.S.

 

Food and Drug Administration (FDA), the condition for the milestone payment, as per the contract, was met.

 

CKD is set to receive an additional milestone payment for the first time since the CKD-510 technology export.

 

CKD-510 is a new drug candidate that CKD out-licensed to Novartis in November 2023.

 

It was a blockbuster technology export agreement with a non-refundable upfront payment of USD 80 million.

 

The maximum milestone payment, contingent on development and approval stages, reaches up to USD 1.225 billion.

 

CKD-510 is a new drug candidate researched and developed by CKD.

 

It is an HDAC6 inhibitor developed using a highly selective non-hydroxamic acid (NHA) platform technology.

 

In preclinical studies, the efficacy of the candidate was confirmed in various HDAC6-related diseases, including cardiovascular diseases.

 

Its safety and tolerability were demonstrated in Phase 1 clinical trials conducted in Europe and the United States.

 

CKD has completed the European Phase 1 trial of CKD-510 for Charcot-Marie-Tooth (CMT) disease.

 

CMT is a hereditary peripheral neuropathy where motor and sensory nerves are damaged due to gene mutations, making normal walking and daily life difficult.

 

It is a rare disease, but there is currently no definitive treatment.

 

CKD has strategized to derive optimal drugs for various diseases based on the fundamental structure of HDAC6 inhibitors.

 

CKD is developing new drugs applying its HDAC6 platform technology to CMT disease, Huntington's disease, Alzheimer's disease, hematologic cancers, and autoimmune diseases.

 

Novartis enters a Phase 2 clinical trial for the first time since in-licensing CKD-510.

 

However, Novartis has not disclosed the target indication for CKD-510.