Hanall Biopharma (009420.KS) has halted development of its autoimmune drug candidate IMVT-1402 for cutaneous lupus erythematosus, but the impact on the candidate's overall value is limited, according to a securities firm analysis. Clinical results in the remaining indications, including difficult-to-treat rheumatoid arthritis and Graves' disease, are expected to determine the asset's future valuation.
IBK Investment & Securities on the 28th valued IMVT-1402 at 3.665 trillion won ($2.6 billion). The firm judged that the discontinuation of one indication does not significantly affect the value of the overall pipeline.
IMVT-1402 is an autoimmune treatment that reduces immunoglobulin G (IgG) in the body by inhibiting the neonatal Fc receptor (FcRn). Immunovant, Hanall Biopharma's U.S. partner, released results on the 23rd from a 12-week proof-of-concept trial in 57 patients with cutaneous lupus erythematosus and said it would discontinue development for that indication. The improvement rate in the Cutaneous Lupus Erythematosus Disease Area and Severity Index activity score (CLASI-A), the primary endpoint, failed to achieve statistical significance against placebo.
IBK Investment & Securities said, however, that the result is difficult to read as a failure of IMVT-1402's mechanism of action itself. Patients with larger reductions in IgG showed higher clinical response rates, and the safety profile was consistent with earlier trial results, the firm said. Its analysis was that IgG reduction through FcRn inhibition did translate into a certain level of clinical response, but that the effect was not strong enough to justify continued development given the competitive landscape.
Attention is shifting to the remaining indications. IMVT-1402 is being developed for difficult-to-treat rheumatoid arthritis as well as Graves' disease, myasthenia gravis, Sjogren's syndrome and chronic inflammatory demyelinating polyneuropathy (CIDP). Follow-up data for difficult-to-treat rheumatoid arthritis are due in the fourth quarter of this year, with topline results for Graves' disease and myasthenia gravis expected in 2027.
Graves' disease is the indication drawing the most attention from analysts. IBK Investment & Securities estimated the target patient population in the U.S. at about 330,000, making it the largest market among the indications currently in development. The firm also cited as a strength that IMVT-1402 is the only FcRn inhibitor in registrational trials for the disease. In an earlier trial of batoclimab, a first-generation FcRn inhibitor, in Graves' disease, eight out of 10 patients maintained thyroid hormone levels within the normal range six months after treatment ended.
The market potential for difficult-to-treat rheumatoid arthritis was also assessed more favorably than before. Reflecting data presented by Immunovant, IBK Investment & Securities raised its estimate of the target patient population in the U.S. to 85,000 from 70,000.
"If efficacy is confirmed in the registrational trials for Graves' disease and myasthenia gravis slated for 2027, the likelihood of commercialization will rise and the value of IMVT-1402 could be revised further upward," IBK Investment & Securities said.
