HanAll Biopharma's autoimmune disease drug candidate "batoclimab" failed to demonstrate efficacy in a phase 3 trial in patients with thyroid eye disease (TED).
Industry observers say the failure has increased the likelihood of a reversion. HanAll Biopharma out-licensed batoclimab to U.S.-based Immunovant.
Immunovant told the U.S. Securities and Exchange Commission (SEC) last year that it was "discussing the reversion of certain rights to batoclimab with HanAll Biopharma," noting that "if HanAll Biopharma does not agree, the matter could proceed to arbitration or litigation."
◇ Lower response rate than placebo… Immunovant to "focus on 'imvotravart'"
On the 2nd (local time), Immunovant said batoclimab did not meet all primary endpoints, adding, "We will review the development plan for batoclimab with HanAll Biopharma and jointly share future updates."
The phase 3 program (IMVT-1401-3201, 3202) enrolled about 200 patients with active thyroid eye disease, with separate studies in Japan and globally. It was designed as a multicenter, randomized, double-blind, placebo-controlled trial across 18 countries.
The key endpoint was the week 24 proptosis responder rate. According to the data, the response rate in the batoclimab arm of study 3201 was 23%, while the placebo arm recorded 15%, failing to achieve statistical significance (p=0.1953).
Results from study 3202, conducted in 11 countries including the United States, were more negative. The response rate in the batoclimab arm (18%) was lower than in the placebo arm (20%), failing to demonstrate efficacy (p=0.7723).
Safety, however, remained consistent with prior results.
Some say the outcome was somewhat anticipated. Concerns over batoclimab's commercial viability have persisted since early development. In 2021, the trial was halted after adverse events, including elevated LDL cholesterol at higher doses, were observed.
Immunovant plans to focus its resources on the follow-up candidate "imvotravart." Imvotravart is currently in clinical development for six indications, including Graves' disease (GD), rheumatoid arthritis (RA), myasthenia gravis, and chronic inflammatory demyelinating polyneuropathy (CIDP).
◇ HanAll's commercialization of batoclimab pushed further out, highlighting financial risk
Analysts say a reversion of rights, if realized, would pose a considerable burden for HanAll Biopharma.
HanAll Biopharma's consolidated operating profit last year was minus 900 million won, turning to a loss from 200 million won a year earlier. It was the first operating loss since 2015.
Operating cash flow also fell to minus 2.3 billion won from 9.3 billion won a year earlier, returning to the red for the first time in seven years since 2018. Borrowing fund of 30.7 billion won occurred for the first time in 10 years.
If batoclimab were to win approval and be commercialized, the additional milestones HanAll Biopharma could receive from Immunovant would total up to $452.5 million (about 680 billion won). As of the third quarter of last year, HanAll Biopharma had received a total of $62.5 million.
As of 1:07 p.m. on the day, HanAll Biopharma was down 11.21% at 48,300 won from the previous trading day.