Industry struggles to develop new atopic dermatitis drugs

But continues on the challenge

Kangstem fails to meet primary endpoint in clinical trial…fails to secure statistical significance

New drug development continues...Daewoong, SN Bioscience, Enzychem, Shapreon starts development

The domestic pharmaceutical bio-industry is facing difficulties in developing new drugs for atopic dermatitis.

 

Recently, Kangstem Biotech's stem cell therapy drug completed Phase III clinical trials, but the results fell short of expectations.

 

JW Pharmaceutical's atopic dermatitis drug candidate failed to prove its efficacy in a Phase II clinical trial.

 

Nevertheless, the companies’ challenge to develop atopic dermatitis drugs continues.

 

Enzychem Lifesciences submitted an IND for Phase II trial earlier this month, and Shapreon is conducting Phase I/IIa clinical trials in Korea and the United States.

 

SCM Life Science, Daewoong Pharmaceutical, and Novacell Technology are also developing new drugs with new mechanisms of action for atopic dermatitis.

 

#iOn the 19th, according to industry sources, Kangstem Biotech announced on the 4th that its atopic dermatitis drug candidate ‘Furestem-AD inj' failed to meet the primary endpoint in Phase III clinical trials.

 

This is the second time in 2019 that Kangstem Biotech has failed to achieve statistical significance with Furestem-AD.

 

In October 2019, the company failed to achieve statistical significance in the Eczema Severity Index (EASI)-50 endpoint with Furestem-AD and discontinued trials.

 

Furestem-AD is being developed for patients with moderate-to-severe atopic dermatitis eczema who have not responded to existing treatments, including topical and systemic steroids.

 

The Phase III trial was conducted from September 2021 through August 2023 and enrolled a total of 315 adult patients with moderate-to-severe chronic atopic dermatitis who had not responded to existing treatments.

 

The primary endpoint was the percentage of patients achieving Eczema Severity Index (EASI)-50, a measure of atopic severity, at 12 weeks.

 

EASI-50 is defined as a 50% improvement in atopic dermatitis symptoms after treatment.

 

Clinical results showed that 33.0% of patients achieved EASI-50 in the Furestem-AD treatment arm compared to 29.3% of patients in the placebo arm.

 

The percentage of patients achieving EASI-50, which is a measure of atopic severity, was 58% at 1 year, 66% at 2 years, and 75% at 3 years with Furestem-AD.

 

While Furestem-AD was associated with a higher rate of EASI-50 achievement than placebo, the difference was not statistically significant (P=0.6111).

 

However, Kangstem Biotech plans to proceed with the license application due to the significant effect of Furestem-AD in long-term administration.

 

Furestem-AD increased the EASI-50 achievement rate to 48.1% at week 16 and 58.1% at week 24.

 

In terms of safety, Furestem-AD was associated with fewer adverse events than placebo after week 12.

 

JW Pharmaceutical's innovative new drug candidate also failed to meet the primary endpoint.

 

The Danish pharmaceutical company LEO Pharma returned the rights to JW1601, an atopic dermatitis drug, and terminated the technology transfer agreement with JW Pharmaceutical.

 

JW1601 has a dual mechanism of action that selectively acts on the histamine H4 receptor to block the activity and migration of immune cells that cause atopic dermatitis and inhibit histamine signal transduction.

 

Histamine is a neurotransmitter involved in allergic reactions.

 

However, the global Phase II trial reportedly failed to meet its primary endpoint.

 

As there are no atopic dermatitis drugs with this mechanism of action, it could have become a first-in-class drug if developed but did not reach commercialization.

 

The company plans to review future development directions, including the possibility of securing new indications.

 

Development of new atopic dermatitis drugs continue

Despite the failure experienced by some companies in proving the efficacy of their drug candidates in clinical trials, the challenge of developing new drugs for atopic dermatitis continues in the domestic pharmaceutical and biotech industry, SCM-AGH, a stem cell therapy for atopic dermatitis being developed by SCM Life Science, also secured positive results in Phase II clinical trials.

 

The company held an IR meeting last month to explain the detailed clinical results of SCM-AGH and future development plans.

 

In a study comparing the efficacy and safety of SCM-AGH versus placebo, SCM-AGH met its primary endpoint.

 

The drug also showed significant results in the secondary endpoint, ESAI-90 at 24 weeks.

 

Also, no adverse events were reported among the 55 subjects who received SCM-AGH.

 

The no adverse events were deemed positive as some inflammation treatments have been associated with safety concerns.

 

SCM Life Science plans to conduct a Phase III clinical trial in Korea with Handok.

 

On the 3rd, Enzychem Lifesciences filed an IND to initiate a Phase II clinical trial for atopic dermatitis to the Ministry of Food and Drug Safety.

 

Based on its immunomodulatory function, EC-18’s mechanism quickly eliminates the hypersensitive immune response caused by allergens, which is the main cause of atopic dermatitis.

 

The trial will evaluate the efficacy and safety of EC-18 in 120 patients with moderate or severe atopic dermatitis.

 

Shapreon’s atopic dermatitis treatment, NuGel, is in clinical trials in the U.S.

 

After receiving global Phase II IND approval for NuGel from the U.S.

 

Food and Drug Administration (FDA) in September last year, Shapreon successfully enrolled its first patient in March of this year.

 

NuGel works by activating GPCR19, which blocks the inflammasome pathway to inhibit cytokine secretion.

 

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

 

DWP212525, which targets JAK3 and TEC family kinase (TFK), is in the preclinical trial, and DWP213388, a BTK-ITK inhibitor, is in its Phase I clinical trial.

 

Novacell, an affiliate of DongKoo Bio&Pharma, is developing NCP112 for the treatment of mild-to-moderate atopic dermatitis targeting formyl peptide receptor 2 (FPR2), a G protein-coupled receptor (GPCR) involved in inflammation.