Calliditas Therapeutics: On The Watch For Nefigard Data

Shares of Calliditas Therapeutics AB (CALT) have gained nearly 21% so far this month, as the company gears up for a clinical trial catalyst this quarter.

Calliditas, based in Sweden, is a clinical-stage biopharmaceutical company developing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases.

The lead product candidate is Nefecon, a proprietary, novel oral formulation of budesonide, for the treatment of the autoimmune renal disease IgA nephropathy.

A phase III trial evaluating the effect of Nefecon in patients with IgA Nephropathy (IgAN) who are at risk of developing End-Stage Renal Disease, dubbed Nefigard, is underway.

The Nefigard study, designed to enroll 450 participants, consists of two parts – Part A and Part B.

Part A of the study, which enrolled the first patient in November 2018, completed the required full recruitment of all 200 patients in December 2019. Topline data from Part A of the study is expected this quarter (Q4, 2020).

If all goes well as planned, Calliditas plans to seek regulatory approval for Nefecon in the United States and the European Union in the first half of 2021.

Enrollment in Part B of the study is underway, with 160 patients expected to be recruited.

IgA nephropathy, also known as Berger’s disease, is a kidney disease caused by the accumulation of a protein known as immunoglobulin A in kidneys, causing inflammation and damage to kidney tissues. IgA nephropathy often leads to the end-stage renal disease for which there no approved treatments. The market opportunity for Nefecon is estimated to be $9 billion to $10 billion in the U.S. alone.

The company is also planning to explore the potential of Nefecon in other autoimmune diseases like autoimmune hepatitis and primary biliary cholangitis.

Calliditas Therapeutics went public on the Nasdaq Global Select Market, offering its shares in the form of American Depositary Shares at a price of $19.50 per ADS, on June 5, 2020, under the ticker symbol “CALT”. The stock is also listed on Nasdaq Stockholm under ticker “CALTX”.

CALT has thus far hit a low of $19.00 and a high of $32.07. The stock closed Friday’s (Oct.16, 2020) trading at $28.99, down 0.82%.

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