Full Press Release Details
First patient in China enrolled in clinical phase 3 study NefIgArd with lead candidate Nefecon
Calliditas Therapeutics AB (publ) ("Calliditas")
today announced that the first patient in China has been randomized into confirmatory part of the NefIgArd Phase 3 trial by its
partner, Everest Medicines.
Following IND approval by the NMPA in December of 2019 and subsequent
approval by Human Genetic Resources Administration of China (HGRAC), the first patient in China has now been randomized in the
Phase 3 NefIgArd trial. The first patient in NeflgArd was randomized by Calliditas in November 2018, and in December 2019 Calliditas
announced the full recruitment of the 200 patients required for regulatory submission (Part A). Topline data for these 200 subjects
is targeted for Q4 of 2020, which subject to positive data will form the basis for regulatory approval and market access in the
US and Europe. The study has continued to recruit an additional 160 patients in order to complete the confirmatory part (Part B)
of the trial, which relates to the validation of the surrogate marker, proteinuria. Everest Medicines is contributing to the recruitment
of these 160 patients, based on the roll-out across centers in China.
"We are very pleased to now have the first patient from
mainland China enrolled into the NefIgArd trial. As this disease represents a significant unmet need in Asia, we are excited that
Everest Medicines have achieved this milestone, which supports the goal of completing recruitment before the end of the year,"
said Ren e Aguiar-Lucander, CEO of Calliditas Therapeutics.
For further information, please contact:
Ren e Aguiar-Lucander, CEO, Calliditas
Mikael Widell, Investor Relations
Tel.: +46 703 11 99 60, email: Mikael.widell@calliditas.com
The information was sent for publication, through the agency
of the contact persons set out above, on September 8, 2020 at 08:00 a.m. CET.
Calliditas Therapeutics is a specialty pharmaceutical company
based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with
an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas' lead product candidate,
Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the
treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are
no approved treatments. Calliditas is running a global Phase 3 study within IgAN and, if approved, aims to commercialize Nefecon
in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT).
Visit www.calliditas.com for further information.
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