ARTham Therapeutics announced today that the first patient has been dosed in a Phase 2 clinical trial evaluating ART-648 as a potential treatment for bullous pemphigoid (jRCT2071210034). ART-648 is a novel orally available PDE4 selective inhibitor with excellent pharmacokinetic, pharmacodynamic and safety profile that have been demonstrated in its Phase 1 trial in healthy adults.

This Phase 2 trial is a multi-center, double-blind, placebo-control, randomized controlled study to evaluate the efficacy, safety, and pharmacokinetics of ART-648 in patients with bullous pemphigoid. The trial is enrolling a total of 30 patients. The primary endpoint of the trial is the proportion of patients achieving the cessation of new lesion formation (erosion/blister or wheal/erythema) without rescue therapy at week 4. Secondary endpoints include the proportion of patients achieving the cessation of new lesion formation without rescue therapy at week 2, changes from baseline to week 2 and 4 in bullous pemphigoid disease activity index (BPDAI) score, pruritus VAS score, and proportion of patients receiving rescue therapy at week 2 and 4.

About bullous pemphigoid

Bullous pemphigoid, one of the rare diseases in elderly population, is an autoimmune skin disease that causes edematous erythema, itchy blisters, and erosions of the skin and mucous membranes throughout the body. Bullous pemphigoid is most commonly treated with oral or topical corticosteroids. Anti-inflammatory medications may also be useful in mild cases. Severe cases may require the use of immunosuppressant medications. Oral corticosteroids can have serious side effects, so there is high demand for an effective anti-inflammatory agent, which tapers regimen of corticosteroid.

About ART-648

ART-648 is an orally available PDE4 inhibitor that is currently under development for bullous pemphigoid. ART-648 potently and selectively inhibits PDE4 enzyme and exhibits direct “anti-inflammatory,” “antimetabolite,” and “antifibrotic” effects in multiple disease relevant in vitro or in vivo models. In addition, ART-648 possesses superior physico-chemical properties, which contribute to tolerability profile similar or better to marketed PDE4 inhibitors demonstrated in its phase 1 study.

About ARTham Therapeutics

ARTham Therapeutics is a clinical stage biopharmaceutical company that will deliver “medicines that matter” for patients, with a compelling portfolio developed through unraveling hidden value of existing pharma assets. ARTham is a virtual R&D company that seeks the best academic and business partners to rapidly develop high value clinical candidates. The company is headquartered in Yokohama, Japan. For more information, please visit https://www.arthamther.com/en/

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