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Immunovant (IMVT) Focus on Developing Autoimmune Disease Drug
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Immunovant, Inc. (IMVT - Free Report) is making good progress with the development of its lead pipeline candidate, batoclimab (formerly IMVT-1401), a fully human, monoclonal antibody that selectively binds to and inhibits neonatal fragment crystallizable receptor (FcRn).
The company is developing batoclimab, as a subcutaneous injection for the treatment of myasthenia gravis (“MG”), warm autoimmune hemolyticanemia (“WAIHA”) and thyroid eye disease (“TED”). The candidate is also being developed for treating other autoimmune diseases. The company is making rapid progress in the batoclimab’s development this year.
In June 2022, the company initiated a pivotal study evaluating batoclimab for the treatment of MG. Top-line data from the same is expected in the second half of 2024.
During the same period, Immunovant also achieved alignment with the FDA’s Division of Ophthalmology to initiate two placebo-controlled phase III studies evaluating batoclimab for treating TED. Both these studies are expected to begin in the second half of 2022. Top-line data from both studies are expected in the first half of 2025.
IMVT plans to evaluate potential new indications for batoclimab and has plans to announce two new indications by next month.
In the absence of a marketed drug, the successful development of batoclimab remains the main focus of Immunovant. There is only one candidate in development in its pipeline. Batoclimab is still in late-stage development and is still a few years away from commercialization. Any developmental setback for batoclimab will be a major setback for the company, leaving an adverse impact on its shares.
Also, batoclimab, if approved, may face competition from other approved drugs for TED, WAIHA or MG.
Horizon Therapeutics’ Tepezza, an anti-IGF-1R antibody, is approved for the treatment of TED.
Horizon is evaluating Tepezza in several label expansion studies. The drug has been one of the key top-line drivers for HZNP since its approval.
In December 2021, the FDA approved argenx SE’s (ARGX - Free Report) Vyvgart (efgartigimod) for the treatment of generalized Myasthenia Gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Argenx is also evaluating efgartigimod in several label expansion studies. ARGX recorded $75 million in sales from Vyvgart for the second quarter of 2022.
Alexion Pharmaceuticals’ [now part of AstraZeneca (AZN - Free Report) ] long-acting C5 inhibitor, Ultomiris IV, is approved for treating gMG.
AstraZeneca added blockbuster rare disease drugs, Soliris and Ultomiris to its portfolio following the acquisition of Alexion in July 2021.The acquisition helped AZN to foray into the rare disease market.
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Immunovant (IMVT) Focus on Developing Autoimmune Disease Drug
Immunovant, Inc. (IMVT - Free Report) is making good progress with the development of its lead pipeline candidate, batoclimab (formerly IMVT-1401), a fully human, monoclonal antibody that selectively binds to and inhibits neonatal fragment crystallizable receptor (FcRn).
The company is developing batoclimab, as a subcutaneous injection for the treatment of myasthenia gravis (“MG”), warm autoimmune hemolyticanemia (“WAIHA”) and thyroid eye disease (“TED”). The candidate is also being developed for treating other autoimmune diseases. The company is making rapid progress in the batoclimab’s development this year.
In June 2022, the company initiated a pivotal study evaluating batoclimab for the treatment of MG. Top-line data from the same is expected in the second half of 2024.
During the same period, Immunovant also achieved alignment with the FDA’s Division of Ophthalmology to initiate two placebo-controlled phase III studies evaluating batoclimab for treating TED. Both these studies are expected to begin in the second half of 2022. Top-line data from both studies are expected in the first half of 2025.
IMVT plans to evaluate potential new indications for batoclimab and has plans to announce two new indications by next month.
In the absence of a marketed drug, the successful development of batoclimab remains the main focus of Immunovant. There is only one candidate in development in its pipeline. Batoclimab is still in late-stage development and is still a few years away from commercialization. Any developmental setback for batoclimab will be a major setback for the company, leaving an adverse impact on its shares.
Also, batoclimab, if approved, may face competition from other approved drugs for TED, WAIHA or MG.
Horizon Therapeutics’ Tepezza, an anti-IGF-1R antibody, is approved for the treatment of TED.
Horizon is evaluating Tepezza in several label expansion studies. The drug has been one of the key top-line drivers for HZNP since its approval.
In December 2021, the FDA approved argenx SE’s (ARGX - Free Report) Vyvgart (efgartigimod) for the treatment of generalized Myasthenia Gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
Argenx is also evaluating efgartigimod in several label expansion studies. ARGX recorded $75 million in sales from Vyvgart for the second quarter of 2022.
Alexion Pharmaceuticals’ [now part of AstraZeneca (AZN - Free Report) ] long-acting C5 inhibitor, Ultomiris IV, is approved for treating gMG.
AstraZeneca added blockbuster rare disease drugs, Soliris and Ultomiris to its portfolio following the acquisition of Alexion in July 2021.The acquisition helped AZN to foray into the rare disease market.