March 10, 2022, Shanghai, China： Maxinovel Pharmaceuticals Co., Ltd. (“Maxinovel” hereafter）announces the dosing of the first healthy volunteer in New Zealand with MAX-40070, an investigational topical liniment, in its First-in-human (FIH) clinical trial (MAX-40070-001, NCT05196711). After completing the Phase I study, MAX-40070 will be studied in patients with autoimmune skin diseases including alopecia areata, atopic dermatitis, and psoriasis.

MAX-40070 is a topical JAK/Tyk2 inhibitor developed by Maxinovel. Oral JAK inhibitors have shown their efficacy in treating a variety of autoimmune skin diseases and preventing disease progression in clinical trials and medical practice. However, there are potential safety concerns for long-term systemic drug exposure. FDA has added black box warnings for certain oral JAK inhibitors (tofacitinib, baricitinib, ruxolitinib, etc.), which limits the use of such dosage form in dermatological disorders. Preclinical studies have shown that topical administration of MAX-40070 could achieve an effective exposure in skin tissue while maintaining low systemic exposure. MAX-40070 has the potential to minimize the systemic side effects of oral JAK inhibitors and eventually demonstrates its high benefit/risk ratio through clinical trials, which may ultimately provide robust evidence to support its more broadly use in treating dermatological autoimmune disorders.

Several pharmaceutical companies are developing topical JAK inhibitors specifically in cream formulation. Incyte's JAK inhibitor, ruxolitinib cream (Opzelura^TM), has been approved by the FDA for the treatment of atopic dermatitis, which has justified the medical value of topical JAK inhibitors. Opzelura failed to meet the primary outcome of a clinical trial to treat alopecia areata, possibly implicated by the distinctive anatomical structure of scalp. With thorough evaluation and exploration of different formulations, Maxinovel finally chose liniment formulation of MAX-40070 to enter clinical trial for the treatment of autoimmune skin diseases including alopecia areata. Liniment is similar to cosmetically used skincare of essence in texture and appearance, which makes it easily acceptable by patients.

 “MAX-40070 is a topically used，potent JAK/Tyk2 small molecule inhibitor. The liniment formulation inhibits the JAK family (JAK1, JAK2, JAK3 and Tyk2) kinase activity in the localized skin lesions through the topical administration while avoiding systemic high exposure, thereby blocking the signal cascade of JAK-STAT pathogenic pathway.” Said Haobo Sun, Pharm D, MBA, the medical lead of the MAX-40070-001 study from Maxinovel.                  

"Thanks to the joint efforts of IQVIA and the New Zealand investigator, we have achieved our goal of enrolling the first subject in this first New Zealand clinical trial for Maxinovel. We will work closely with our New Zealand investigator and IQVIA to continue to focus on the safety and tolerability of the investigational drug in healthy subjects and complete this with high quality." Said Rong Wang, the operation lead of the MAX-40070-01 study from Maxinovel.