HK Innoen Receives Phase 3 Approval for New Atopic Dermatitis Drug for Companion Animals

HK Innoen Square. Photo by HK Innoen

HK Innoen is entering the global pet pharmaceutical market, which is estimated to be worth 30 trillion KRW, with a new drug for treating atopic dermatitis in companion animals (dogs) from the JAK-1 inhibitor class. Among domestic companies, HK Innoen is the only one currently developing a new atopic dermatitis drug for both companion animals and humans using the JAK-1 inhibition mechanism.

On May 28, HK Innoen announced that its atopic dermatitis treatment for companion animals, 'IN-115314,' has recently received Phase 3 clinical trial (IND) approval from the Animal and Plant Quarantine Agency.

With this approval, HK Innoen plans to conduct a clinical trial in dogs suffering from atopic dermatitis, administering IN-115314 and Apoquel tablets (Oclacitinib) orally to each group to evaluate the efficacy in improving pruritus and skin lesions, as well as safety. Approximately 10 animal hospitals in Korea will participate in this clinical trial.

IN-115314 is a novel drug substance that selectively inhibits Janus Kinase-1 (JAK-1), which plays a key role in intracellular signal transduction.

Existing treatments inhibit JAK-2 as well, raising concerns about side effects and resulting in limitations on dosage and administration. However, IN-115314, with its high selectivity and strong JAK-1 inhibitory ability, is expected to offer lower side effects and effective anti-inflammatory action. HK Innoen is currently developing this substance simultaneously as a topical treatment for humans and an oral treatment for companion animals with atopic dermatitis.

The global market for atopic dermatitis treatments for dogs is estimated to be worth $1.6485 billion (approximately 2.27 trillion KRW) this year, and is expected to grow at an average annual rate of 10.3%, reaching $3.2763 billion (approximately 4.5 trillion KRW) by 2032.

Currently, in the market for JAK inhibitor-based atopic dermatitis treatments for companion animals, only products from global pharmaceutical companies are available, specifically Apoquel tablets by Zoetis. In the past year alone, Apoquel recorded global sales of $1.018 billion (about 1.4 trillion KRW), establishing itself as a blockbuster drug. Zoetis has also seen continuous growth in both sales and corporate value, now reaching annual sales of $9.256 billion (about 13 trillion KRW).

An HK Innoen representative stated, "Just as K-Cab, our new drug for gastroesophageal reflux disease, became a success story in its market, IN-115314 will be the next-generation leader to create a new legend in the field of pet pharmaceuticals. We aim to present a new alternative with a domestically developed pet pharmaceutical in a market currently dominated by products from global pharmaceutical giants."

Previously, in March, HK Innoen received Phase 2 clinical trial approval from the Ministry of Food and Drug Safety for a topical atopic dermatitis treatment for humans using IN-115314. The companion animal treatment, which has now received Phase 3 clinical trial approval from the Animal and Plant Quarantine Agency, is being developed as an oral tablet.