Rigel’s ITP Drug Fostamatinib Enters Phase 3 Clinical Trial in Japan

Chronic immune thrombocytopenia (ITP) is a disorder in which the body’s immune system destroys platelets which play a key role in blood clotting and healing. Currently, therapies such as steroids and splenectomy are used to treat ITP. However, patients are not adequately treated with such therapies, thus arising the need for alternative ITP treatment options.

Some advances were made in this field recently when Rigel Pharmaceuticals Inc., a clinical-stage biotechnology company, announced that its partner firm Kissei Pharmaceuticals Co. Ltd., initiated a Phase 3 trial of fostamatinib disodium hexahydrate for treatment of chronic immune thrombocytopenia (ITP) in adult patients.

According to reports, the safety and efficacy of the orally processed drug will be determined by comparing it with placebo in a randomized, double-blind study. Under the brand name TAVALISSE®, fostamatinib is commercially available in the U.S. and is used for treating patients who are suffering from chronic ITP.

Sources claim that the outcomes of this trial will be applied for supporting a new drug application (NDA) which the company is planning to file in late 2021 or early 2022 in Japan. Presently, the European Medicines Agency is reviewing the marketing authorization application for fostamatinib in chronic ITP in adult patients for potential approval in Europe.

For a record, Kissei is a pharmaceutical company in Japan which focuses on patients' unmet medical needs by collaborating with partners as well as by research, development and commercialization. Previously, Kissei offered a Phase 3 trial design to Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and was recently accepted by the agency.

In 2018, Kissei and Rigel collaborated for the commercialization and development of fostamatinib in all current and potential indications in China, Japan, the Republic of Korea and Taiwan.

According to reports, Rigel, under the terms of the deal, received an upfront cash payment of $33 million, with an additional potential for $147 million in commercial and development milestone payment. The company would also receive payments of product transfer price in the range between mid to upper 20% range depending on tiered net sales.

Source Credit – https://ir.rigel.com/news-releases/news-release-details/rigels-fostamatinib-enters-phase-3-clinical-trial-japan-kissei