Biological drug options for psoriasis treatment increase

Pharma companies strengthen their R&D competitivity

UCB Pharma’s interleukin-17 dual inhibitor ‘Bimzelex’ is approved in KOR

Domestic biotechs are also developing new drugs... New biosimilars are also expected to emerge

Domestic and foreign pharmaceutical companies are expanding psoriasis treatment options through the development of biological agents.

 

Recently, Korea's UCB Pharma succeeded in obtaining domestic marketing authorization for a biological drug with a new mechanism of action, sparking competition in the field.

 

Other domestic pharmaceutical and biotech companies such as HK Inn.N and AprilBio have also entered the market by developing new biologics.

 

Celltrion, Samsung Bioepis, and others are planning to expand their influence in the psoriasis treatment market by manufacturing biosimilars of biological drugs.

 

#According to industry sources, the Ministry of Food and Drug Safety approved Korea's UCB Pharma’s interleukin-17 dual inhibitor Bimzelex on the 29th.

 

Bimzelex is the first biologic to simultaneously target interleukin (IL)-17A and F.

 

While biologics targeting IL-17A, such as Lilly's Taltz and Novartis' Cosentyx, have been available in the market, Bimzelex is the first drug to target IL-17F as well.

 

IL-17 is an inflammatory cytokine that causes psoriasis.

 

By targeting both IL-17A and IL-17F simultaneously, it is believed to be able to inhibit the inflammatory cytokines in higher doses and with greater potency.

 

Psoriasis is a chronic, systemic skin disease caused by an abnormality in the immune system, and is characterized by erythema, a reddening of the skin, and psoriasis, which is white, scaly patches of the skin.

 

Bimzelex’s approval is based on the Phase III BE READY study.

 

The study compared the efficacy and safety of Bimzelex versus placebo in patients with plaque psoriasis.

 

Results showed that the primary endpoint, a Psoriasis Area and Severity Index (PASI) score of 90 or greater at Week 16, was 90.8% in the Bimzelex arm.

 

The proportion of patients achieving a PASI score of 100 was 68.2%, and the proportion of patients achieving an overall clinical response (IGA) score of 0 or 1 was 92.6% in the Bimzelex arm, significantly higher than the 1.2% in the placebo arm.

 

Bimzelex also achieved significant PASI score improvements compared to other biologics.

 

Bimzelex achieved significantly higher PASI 100 rates compared to Janssen's Stelara, AbbVie's Humira, and Cosentyx.

 

Bimzelex’s PASI 100 achievement rate was also shown to have been maintained at a high level for 3 years in the BE BRIGHT open-label extension study.

 

Bimzelex is the only IL-17 biologic introduced in Korea that can be dosed once every 8 weeks as maintenance therapy.

 

It can also be self-injected by patients with education.

 

Development of biologics active...competition heats up for psoriasis

The domestic pharma and biotech industry is also developing biologics for psoriasis.

 

Currently, biologics with psoriasis treatment indications include Abbvie’s Humira-Skyrizi, Cosentyx, and Taltz.

 

Domestic biotech companies have also signaled their entry into the market by developing the drugs’ biosimilar versions.

 

Celltrion recently received approval from the U.S.

 

Food and Drug Administration (FDA) for a global Phase III trial of Cosentyx’s biosimilar, ‘CT-P55.’ Cosentyx is a biological drug developed by Novartis that inhibits IL-17A and is effective in a variety of inflammatory diseases, including psoriasis and ankylosing spondylitis.

 

The study will enroll a total of 375 patients with plaque psoriasis.

 

A comparative study will be conducted to demonstrate equivalence in efficacy and safety between the original drug and CT-P55.

 

CT-P55 received Phase I IND approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in December of last year.

 

In addition to Cosentyx, Celltrion has developed a number of other biologics, including biosimilars of Humira and Stelara.

 

The company plans to expand its footprint in inflammatory diseases such as psoriasis with the Cosentyx biosimilar.

 

Samsung Bioepis is challenging this market with the commercialization of its Stelara biosimilars.

 

In April, Samsung Bioepis received approval from the European Medicines Agency (EMA) for Pyzchiva, a biosimilar of Janssen's autoimmune disease treatment Stelara.

 

Pyzchiva is a biologic that treats plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, with annual global sales near KRW 14 trillion.

 

HK Inno.N and AprilBio will develop biologics targeting novel mechanisms of action.

 

HK Inno.N, YBiologics, and IMBiologics recently licensed-out IMB-101, a new drug candidate for autoimmune diseases, to US pharmaceutical company Navigator Medicines.

 

MB-101 is a dual antibody drug candidate that simultaneously controls innate and adaptive immune responses by dual-targeting OX40L and tumor necrosis factor (TNF).

 

The OX40L pathway is involved in the activation of T-cells, and immune cells, and TNF is a cell signaling protein involved in inflammatory responses.

 

IMBiologics received IND approval from the U.S.

 

Food and Drug Administration (FDA) in August last year and is currently conducting Phase I clinical trials.

 

AprilBio has also successfully licensed out its technology for its autoimmune disease drug candidate 'APB-R3' to U.S.

 

new drug developer Evommune.

 

APB-R3 is a biological drug candidate that targets interleukin (IL)-18.

 

IL-18-targeting candidates are known to be effective in various diseases including psoriasis, inflammatory bowel disease, atopic dermatitis associated with metabolic syndrome-related steatohepatitis, and sepsis.

 

AprilBio has confirmed the tolerability and safety of APB-R3 in a Phase I clinical trial.

 

Evommune plans to initiate a Phase II clinical trial for APB-R3 in the first half of next year.