Korean bio companies intent on developing new AD drugs

For atopic dermatitis despite receiving new drug returns

Leo Pharma returns rights for JW Pharmaceutical’s atopic dermatitis drug candidate last month

Clinical trials in Korea continue for the development of homegrown drugs… ‘stem cell treatment’ enters Phase later phase trial

Despite downturns, including the return of the rights for JW Pharmaceutical’s atopic dermatitis drug candidate, clinical trials for new drugs to treat atopic dermatitis are still ongoing in Korea.

 

Last month, JW Pharmaceutical announced that its technology transfer agreement for its atopic dermatitis treatment JW1601 which it signed with the Denmark pharmaceutical company Leo Pharma has been terminated.

 

JW1601 owns a dual-action mechanism that selectively acts on the histamine H4 receptors to suppress inflammation and itching.

 

Histamine is a major mediator of allergic inflammation.

 

However, the candidate was unable to satisfy its primary efficacy endpoint in a global Phase II trial.

 

With no other atopic dermatitis treatment owning the same mechanism of action, the drug had the potential to become a First-in-class drug but was unable to reach the commercialization stage.

 

However, JW Pharmaceutical plans to continue to review its direction of development and potential to acquire new indications.

 

Clinical trials are being actively conducted on various mechanisms that suppress inflammation… stem cell treatment starts later phase trial

In addition to the failed candidate that targets histamine H4 receptors, various new drug candidates that target atopic dermatitis are being developed in Korea right now.

 

A Stem cell therapy, as well as new drug candidates targeting Bruton's tyrosine kinase (BTK), interleukin-2-inducible T-cell kinase (ITK), and Janus kinase (JAK) are also being studied for commercialization potential.

 

One of the candidates that is evaluated to be close to commercialization is a stem cell treatment.

 

Kangstem Biotech is a leader in the field of stem cell treatments for atopic dermatitis.

 

The company recently completed patient administration of ‘FURESTEM-AD Injection,’ a new drug candidate being developed in a Phase III trial.

 

FURESTEM-AD Inj is being developed as a treatment for patients with moderate-to-severe atopic dermatitis who have not responded to existing treatments.

 

Kangstem Biotech plans to complete the Phase III trial by the first half of next year and apply for its marketing approval.

 

Interim results of the Phase III long-term follow-up study disclosed by the company showed that in patients who were administered FURESTEM-AD Inj, 58% achieved Eczema Area and Severity Index-50 (EASI-50) in the first year, 66% in the second year, then 75% in the third year.

 

EASI-50 refers to the percentage of patients whose dermatitis symptoms improved by more than 50% compared to the baseline.

 

‘SCM-AGH,’ a stem cell treatment for atopic dermatitis that is being developed by SCM Lifescience, has also secured positive results in a Phase II trial.

 

In a clinical trial comparing the efficacy and safety of SCM-AGH compared with placebo, SCM-AGH met the primary endpoint.

 

Also, the SCM-AGH arm saw significant results in the secondary endpoint achieving ESAI-90 at 24 weeks.

 

Also, none of the 55 subjects who were administered SCM-AGH showed side effects.

 

Due to safety issues that arose in some inflammation treatments the fact that no side effect occurred is considered positive.

 

SCM Lifescience plans to conduct its Phase III clinical trial in Korea with Handok.

 

In addition, Daewoong Pharmaceutical is conducting 2 clinical trials in the US.

 

Its ‘DWP212525’, which targets JAK3 and TEC family kinase (TFK), is in a preclinical trial, and ‘DWP213388’, a BTK/ITK inhibitor, is in a Phase I clinical trial.

 

Novacell, an affiliate of DongKoo Bio&Pharma, is developing NCP112, which targets G protein-coupled receptors (GPCRs) and formyl peptide receptor 2(FPR2), which are involved in the resolution of inflammation, as a treatment for mild-to-moderate atopic dermatitis.

 

NuGel, a GPCR19-targeted inflammation modulator being developed by Chaperone in the US, has successfully entered Phase II trials.