Shares were up over 60% in premarket trading on news that the company’s anti-FcRn antibody exhibited dose-dependent reductions in IgG levels, drivers of inflammation in many autoimmune diseases.
Pictured: Autoimmune written on clipboard/iStock, Zerbor
Investors were buzzing Tuesday morning on the release of positive initial Phase I data for Immunovant’s autoimmune antibody, sending stock prices up over 60% in premarket trading on the news.
In the trial, IMVT-1402 exhibited dose-dependent reductions in Immunoglobulin G (IgG) levels similar to or greater than that observed in Immunovant’s other investigational therapy batoclimb. The subcutaneous antibody injection targets neonatal fragment crystallizable receptor (FcRn) to promote the degradation of the harmful IgG autoantibodies that lead to autoimmune disease.
Data on the multiple-ascending dose (MAD) cohort will be shared in November, the company said, adding that safety data were “generally favorable” and no decrease in serum albumin or increase in low-density lipoprotein (LDL) cholesterol were observed.
The potential reach for a FcRn-inhibitor is vast. According to Immunovant, over two million people are living with conditions driven by harmful IgG autoantibodies. In May, analysts predicted a massive 200% stock rise if the MAD data—expected in November—showcases a clean safety profile with broad applicability.
If successful, Immunovant won’t be the first FcRN-inhibitor on the market. In June 2023, the FDA approved UCB’s Rystiggo (rozanolixizumab) for two forms of myasthenia gravis (MG) after a Phase III trial showed the drug led to significant quality of life improvements such as the ability to breathe, talk, swallow and rise from a chair.
The first on the market was argenx’s Vyvgart (efgartigimod), approved in 2021 for a particular population of MG patients positive for anti-acetylcholine receptor antibodies. The FDA approved the self-administered, subcutaneous version of the drug in June 2023.
A positive Phase II data release for Vyvgart in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) helped argenx raise $1.1 billion in a global stock offering in July 2023. CIDP is a neurological disorder that occurs when the immune system attacks the myelin sheaths around nerve cells.
Myasthenia gravis seems to be a popular initial target for the FcRn inhibitor class. Immunovant’s batoclimab is in Phase III trials for the condition, as well as earlier stage testing for thyroid eye disease, Graves’ disease and CIDP.
The biotech has yet to name a specific autoimmune target for IMVT-1402. Roivant CEO Matthew Gline told STAT News the data “leaves a wide range of possible paths forward for this drug.”
Shares of Roivant, Immunovant’s parent company and largest shareholder, rose nearly 13% before the opening bell Tuesday morning.
Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.
