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KX01 in Psoriasis

Background

Psoriasis is a common autoimmune disease characterized mainly by the formation of inflammatory diseases, raised plaques that constantly shed derived from excessive growth of skin epithelial cells. The age of onset of psoriasis occurred from infants to the elderly, the highest incidence rate was at middle-aged and young, there is about 80% of KX01 population was aged 15 to 45 according to clinical investigations. It is an annoying disease that seriously endangering the physical and mental health of people.

According to the National Psoriasis Foundation estimates, the total number of global psoriasis patients has exceeded 125 million, affecting approximately 1-3% of the general population worldwide, with chronic plaque psoriasis accounting for approximately 85-90 % of all cases. Men and women develop psoriasis at equal rates. Psoriasis also occurs in all racial groups, but at varying rates. About 1.9 % of African-Americans have psoriasis, compared to 3.6 % of Caucasians. The incidence in China is about 0.8%, with about 500 to 600 million people with psoriasis. Although there is no official prevalence rate reported in Taiwan, in the National Health Research Insurance Database, the number of psoriasis visits in Taiwan is about 80,000 to 100,000 and there are roughly 110,000 psoriasis patients.

Unmet Medical Needs

Psoriasis is one of the top 10 chronic diseases in the world. Tens of Millions of psoriasis patients are still suffering from the disease in the world. Most of the treatment for psoriasis are external use. Others are oral and injectable biological agents. These treatment can reduce the symptoms, but there is still no radical cure. Various treatments for psoriasis only achieve short-term curative effect and can not prevent recurrence. The side effects of drug treatment, the new target biologics are expensive, no insurance payments in domestic, there is still no common and effective treatments for the side. More sun exposure is one of the traditional therapies for psoriasis, but too much sun exposure will be the risk of skin cancer.

Incentive of The Trial

KX01 is a potent inhibitor of keratinocyte proliferation, with activity similar to that observed for transformed cell lines. Topically applied KX01 is therefore expected to limit keratinocyte expansion and alleviate pathology associated with psoriasis. This study will evaluate the safety, tolerability and activity (efficacy) of multiple topical administrations of KX01 ointment. Previous in vitro studies have found that KX01 has anti-proliferative effect in keratinocyte, . anti-neovascularization in endothelial tube test and immunosuppressive effect that inhibition of T Cell movement. It is estimated that KX01 will prove its highly psoriasis medical effect in clinical trials which will replace most commercial products, including biologics for injection; KX01 is intended for topical administration with minimal side effects.