[Edaily Reporter KIM SAE-MI ] ImmunoVant, a partner company of HANALL BIOPHARMA CO.,LTD(009420), failed to meet the primary endpoint in the proof-of-concept (PoC) clinical trial for “Imeropruvate” (IMVT-1402), a treatment for autoimmune diseases, specifically for cutaneous lupus erythematosus (CLE). ImmunoVant has decided to discontinue development for the CLE indication, taking into account the clinical results and the competitive market landscape.

HANALL BIOPHARMA CO.,LTD announced on the 24th that ImmunoVant had released topline results from Period 1 of the Phase 2b Proof-of-Concept (PoC) clinical trial for imeroprubate on the 23rd (local time).

This clinical trial was a randomized, double-blind, placebo-controlled global study involving 57 adult patients with CLE. Patients were divided into an imerofruvat treatment group and a placebo group and received treatment for 12 weeks.

The primary endpoint was the change from baseline in the Clinical Lupus Erythematosus Area and Severity Index Activity (CLASI-A) at Week 12. The imeroprubate group did not achieve statistical significance compared to the placebo group for this endpoint. Immunovant did not disclose specific change rates or p-values.

However, the company explained that across several evaluation variables, a trend toward numerically greater improvement was observed in the imeroprubate group compared to the placebo group. A representative from HANALL BIOPHARMA CO.,LTD emphasized, “Patients with a greater reduction in immunoglobulin G (IgG) levels from baseline tended to show improved clinical responses,” adding, “Safety and tolerability were consistent with previous clinical results.”

However, ImmunoVant determined that these results did not meet the company’s internal criteria for continuing the development of imeropruvate for CLE. After comprehensively evaluating the clinical results alongside the competitive landscape of the CLE treatment market, the company decided not to proceed with further development for this indication.

Regardless of the suspension of CLE development, other clinical trials of imeropruvate for autoimmune diseases will proceed as scheduled. It is currently being developed for △Graves’ disease, △refractory rheumatoid arthritis (D2T RA), △myasthenia gravis (MG), △chronic inflammatory demyelinating polyneuropathy (CIDP), and △Sjögren’s syndrome. Results from Period 2 of the refractory rheumatoid arthritis clinical trial are scheduled to be announced in the second half of this year.

A HANALL BIOPHARMA CO.,LTD official stated, “While the results of the cutaneous lupus erythematosus clinical trial were disappointing, they reaffirmed the IgG-reducing effect and favorable safety profile of imeropruvate,” adding, “We will spare no effort in commercializing key indications—including Graves’ disease, refractory rheumatoid arthritis, and myasthenia gravis—in collaboration with Immunovant.”

Meanwhile, Imeropruvate is an antibody therapy that reduces IgG levels by targeting the neonatal Fc receptor (FcRn). It was developed by HANALL BIOPHARMA CO.,LTD, and ImmunoVant is currently conducting global clinical trials for the drug.