Reistone Announces Positive Topline Phase 2 Results for SHR0302, a Selective JAK1 Inhibitor, for Treatment of Patients with Alopecia Areata

- Once-daily, oral SHR0302, a selective JAK1 inhibitor, met primary efficacy endpoint and demonstrated statistically significant, and clinically relevant percentage change in SALT score versus placebo

- A promising new late-stage asset with potential to fulfill the strong unmet medical needs of patients with alopecia areata. There is yet to be an FDA-approved medication for this indication

-SHR0302 to advance to phase 3 for alopecia areata

SHANGHAI, Aug. 24, 2021 /PRNewswire/ -- Reistone Biopharma ("Reistone"), a leading biotech focused on development of treatments for immune & inflammation related diseases, today announced positive topline results from a Phase 2 study evaluating the safety and effectiveness of once-daily SHR0302 in adults with alopecia areata (AA). Two doses (8 mg and 4 mg) met the primary endpoint, demonstrating statistically significant and clinically relevant percentage change of SALT score versus placebo. Treatment was well tolerated, and safety was consistent with other JAK1 inhibitors. AA is an autoimmune disease that causes hair loss in patches or sometimes complete hair loss, leading to high psychological burden. Currently, there are no U.S. Food and Drug Administration (FDA)-approved medications for the treatment of AA.

The primary endpoint was assessed through the Severity of Alopecia Tool (SALT) score at week 24, defined by the percent change from baseline. Primary endpoint in 8 mg and 4 mg groups were met with statistically significant percentage change from baseline in SALT score versus the placebo group. SHR0302 8mg and 4mg groups also met the secondary endpoint of absolute change in SALT score at week 24.

Safety of SHR0302 was consistent with established profiles from previous studies of other JAK class of medication and was well tolerated with no major adverse cardiovascular events (MACE), deaths, or venous thromboembolic events (VTEs) reported from the study.

"There are still unmet needs for patients suffering from alopecia areata (AA) as this is much more than hair loss," said Jianzhong Zhang, Peking University People's Hospital. "The psychological burden experienced by patients is overwhelming, and the results from this trial have shown that SHR0302 has the potential to address these unmet needs."

"We are very much focused on the development of an effective and convenient treatment for patients living with alopecia areata who today do not have access to an approved treatment for their condition, and we believe SHR0302 has potential to become a best-in-class treatment for alopecia areata," said Min Irwin, CEO and Founder of Reistone. "The results are highly encouraging, and we will look forward to advancing SHR0302 into phase 3 to bring relief for patients living with alopecia areata."

CRYSTAL2 (NCT04346316) was a double-blinded, randomized, placebo-controlled phase 2 program designed to evaluate the safety and efficacy of the investigational drug SHR0302 in adult patients with moderate-to-severe AA. 94 patients with 25% or greater scalp hair loss were randomized to one of three doses of SHR0302 (8 mg, 4 mg, or 2 mg) or placebo. The primary outcome measure assessed the percentage change from baseline in SALT score, a quantitative assessment of AA severity based on scalp hair loss, at week 24. The study included a diverse patient population across 34 sites from Australia, China, and the US.  

About SHR0302

SHR0302 is a potent and highly selective Janus kinase type 1 (JAK1) inhibitor. Several late-stage clinical studies are on-going with both oral and topical dosage forms for several immune-inflammatory diseases including atopic dermatitis, alopecia areata vitiligo, ulcerative colitis, and Crohn's disease. The high selectivity of SHR0302 may potentially provide a favorable safety and efficacy profile compared to the pan-JAK inhibitors. SHR0302 was granted Breakthrough Therapy designation by China's CDE for treatment in atopic dermatitis in January 2021.

Alopecia areata (AA)

Alopecia areata (AA) is an autoimmune disease that causes patchy hair loss and in some cases, complete hair loss. Hair loss can affect any areas of the body where hair follicles exist; however, it is most noticeable on the scalp and eyebrow because of their visible location. Changes in physical appearance resulting from hair loss pose significant psychological burden for patients, greatly impacting the quality of life for many patients. Current treatment includes corticosteroids and immunosuppressants, which are associated with undesirable side effects. AA affects about 2% of the population globally and approximately 4 million people in China.

About Reistone Biopharma

Reistone Biopharma Co. Ltd. is a leading biopharmaceutical company focused on developing novel medicines aimed at treating autoimmune and inflammatory diseases that have high unmet needs. The company was founded in January 2018 and is headquartered in Shanghai, China with additional operations in Beijing, China, and Chicago and Boston, United States. It currently employs about 160 people in China and the United States. Further information about the company and its drug development programs and capabilities may be found online at http://www.reistonebio.com  

Contact Information

China Contact

Aik Han Goh
Vice President
Chief Medical Officer
+86-21-68813360
aik.goh@reistonebio.com

US Contact

Qais Mekki
Sr. Vice President
Head of International Development
US Site Head
+1-815-388-4700
qais.mekki@reistonebio.com

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