Abbisko and Sperogenix Announce an Exclusive Agreement to Develop ABSK021 for ALS and Other Rare Neurological Diseases in Greater China

Sperogenix MedTech Co., Ltd., a subsidiary of Sperogenix Therapeutics, has entered into an exclusive licensing agreement with Abbisko Therapeutics Co., Ltd., a Chinese biopharmaceutical company focused on innovative drug discovery and development, to collaborate on the development and commercialization of innovative drug ABSK021 for indications in the field of rare neurological diseases.

Under the agreement, Sperogenix will have the exclusive right to develop, manufacture and commercialize ABSK021 in mainland China, Hong Kong SAR and Macao SAR for non-oncology rare neurological diseases indications, of which amyotrophic lateral sclerosis (ALS) will be the first indication to be developed by Sperogenix. Abbisko will receive an upfront payment and a series of milestone payments as well as royalties on annual net sales from Sperogenix, and reserves the rights for all the other territories and indications. Sperogenix will be responsible for the development of ABSK021 in ALS, including preclinical studies, proof-of-concept clinical trials, pivotal clinical trials, and post-marketing studies, as well as the registration and commercialization of the product in the Sperogenix Territory.

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ABSK021 is an orally bioavailable, potent, and selective colony-stimulating factor 1 receptor (CSF-1R) antagonist. Phase Ib clinical trials on safety, tolerability, and pharmacokinetics in oncology patients are being initiated both in China and the United States. Preliminary clinical data has demonstrated that ABSK021 was well tolerated, with favorable pharmacokinetic properties, and effective modulation of the target. CSF-1R signal transduction is involved in the development and survival of microglia. The presence of a large number of activated microglia is one of the hallmarks of neurodegeneration in ALS patients. Preclinical studies have shown that inhibition of CSF-1R could prevent disease progression of ALS in a variety of animal models.

In the summer of 2014, a rare disease known as ALS was introduced to the public with the worldwide “Ice Bucket Challenge”. The clinical characteristics of ALS are progressive limb weakness, muscular atrophy combined with pyramidal sign, accompanied by alalia, dysphagia and other bulbar symptoms, dyspnea caused by respiratory muscle deterioration and eventually death due to nutrition depletion and respiratory failure. According to an analysis of the national medical insurance data by the ALS cooperative group of the Neurology Society of Chinese Medical Association, the annual incidence of ALS in China is 1.62 per 100,000, and the annual prevalence rate is 2.97 per 100,000. At present, there is no specific treatment for the disease, and the prognosis is poor. The median survival time is only 3 to 5 years, which imposes heavy burden on families and society physically, emotionally and economically.

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Mr. Yan Zhiyu, Co-founder, Chairman and CEO of Sperogenix, said, “Rare neurological diseases such as ALS have a serious impact on patients’ survival time and quality of life, which places a heavy burden on patients’ families and society. A series of innovative therapies are urgently needed to improve the status of this disease field. Rare neurological diseases is a key area for Sperogenix. The strong cooperation with Abbisko will accelerate the clinical development and commercialization process of ABSK021, further strengthen our product portfolio in this field, and to establish Sperogenix’s leading position in the space of rare neurological diseases in China.”

“This cooperation between Abbisko and Sperogenix is encouraging and demonstrates the great potential of ABSK021, an innovative CSF-1R drug candidate in the field of neurological diseases” said Dr. Xu Yaochang, Founder and CEO of Abbisko, “Sperogenix has impressive clinical research, development and commercialization capabilities in the field of rare diseases, and we are confident that this cooperation will further accelerate the development process of ABSK021 and benefit patients with rare diseases in China.”

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