HanAll Biopharma Says Development of Autoimmune Disease Drug "IMVT-1402" Is on Track

HanAll Biopharma announced on the 9th that the clinical trials of its autoimmune disease treatment candidate "IMVT-1402" are progressing smoothly.

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Roivant, the parent company of Immunovant, HanAll Biopharma's partner, announced the development status of "IMVT-1402" during its earnings release on the 6th (local time).

IMVT-1402 is one of the FcRn inhibitor candidates that HanAll Biopharma out-licensed to Roivant in 2017. Clinical trials are currently proceeding as planned in a total of six autoimmune diseases: Graves' disease (GD), difficult-to-treat rheumatoid arthritis (D2T RA), myasthenia gravis (MG), chronic inflammatory demyelinating polyneuropathy (CIDP), Sjogren's disease (SjD), and cutaneous lupus erythematosus (CLE). It is expected to become an effective treatment option for more than about 600,000 patients in the United States alone.

In particular, patient enrollment for the registration trial of IMVT-1402 in difficult-to-treat rheumatoid arthritis has progressed rapidly, completing enrollment of 170 patients, which is more than originally planned, and top-line results are scheduled to be announced in the second half of this year. HanAll Biopharma explained that no major safety issues have been identified so far.

The proof-of-concept trial for cutaneous lupus erythematosus is also aiming to secure top-line results in the second half of the year.

Along with this, Immunovant released a single-patient case observed in the open-label study of the cutaneous lupus erythematosus proof-of-concept (PoC) trial scheduled for this year. Cutaneous lupus erythematosus is a disease in which chronic inflammation occurs in the skin due to abnormalities in the immune system, accompanied by symptoms such as red rashes, pain, itching, burning sensations, and hair loss. In severe cases, it can lead to scarring, pigmentary changes, and permanent hair loss.

According to data disclosed by the company through its IR materials, in a patient who received a high dose (600 mg) of IMVT-1402 for 12 weeks, the "CLASI-A" score, which assesses the degree of skin inflammation, fell from 36 points to 13 points, a reduction of more than 60%, and meaningful clinical improvement was observed in hair loss and skin lesions. At week 12, blood antibody (IgG) levels had decreased by a total of 78% compared with the start of treatment.

HanAll Biopharma CEO Jung Seungwon said, "We are encouraged that the clinical development of IMVT-1402 is progressing faster than planned," adding, "We expect that the data to be released in the second half of the year will more clearly demonstrate its differentiated therapeutic effect and competitiveness."

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