Phase 3 Nefecon Trial Begins in Japan

STOCKHOLM, July 4, 2024 -- Calliditas Therapeutics AB (NASDAQ: CALT) (STO: CALTX) ("Calliditas") announced today that its partner, Viatris Pharmaceutical Japan G.K. ("Viatris"), has commenced a phase III clinical trial in Japan for Nefecon, also known as VR-205 in the Japanese market. This trial targets Japanese patients suffering from IgA nephropathy (IgAN).

The clinical study being conducted is a bridging study, which means it requires only a limited number of Japanese patients. The design of this trial closely mirrors that of the global NefIgArd trial. IgA nephropathy, classified as a designated retractable disease in Japan, affects an estimated 33,000 patients in the country. Treatment options for IgAN in Japan are currently limited, highlighting the significance of this clinical trial.

Calliditas Therapeutics has entered into a licensing agreement with Viatris. This partnership aims to register and commercialize Nefecon, a specialty therapy for IgA nephropathy, within the Japanese market. The initiation of this phase III clinical trial marks a significant milestone in the collaboration between Calliditas and Viatris, reflecting their commitment to addressing the treatment needs of IgAN patients in Japan.

Nefecon, already part of the global NefIgArd trial, is being evaluated for its potential to offer a new therapeutic option for those suffering from IgA nephropathy. The disease, which leads to end-stage renal disease in many patients, has few effective treatments currently available. The success of this trial could lead to a new, much-needed therapy option for patients in Japan.

The trial's design is intended to ensure that the results are consistent with the global studies, thereby affirming the drug's efficacy and safety across different populations. This bridging study is crucial as it could expedite the availability of Nefecon to Japanese patients, pending successful trial results and regulatory approvals.

The collaboration between Calliditas and Viatris demonstrates a strategic approach to leverage existing clinical data while adapting to specific regulatory and clinical requirements in Japan. This approach not only aims to facilitate faster patient access to innovative treatments but also underscores the importance of international partnerships in advancing global healthcare.

Overall, the initiation of the phase III trial in Japan is a promising development for the treatment landscape of IgA nephropathy. With a disease burden affecting tens of thousands of individuals and limited existing treatments, the potential introduction of Nefecon into the Japanese market could mark a significant advancement in patient care. The ongoing efforts by Calliditas and Viatris are poised to make a meaningful impact on the lives of those suffering from this challenging condition.