Active development of new drugs for myasthenia gravis

Korean and global pharmas join the race

UCB's Zilbrysq receives approval in South Korea…Janssen prepares for global approvals

Handok acquires new drug from the U.S.-based pharma company…HanAll Biopharma is conducting a phase 3 trial

Competition in the pharmaceutical market is heating up to secure myasthenia gravis indication.

 

UCB's new drug was approved in South Korea, and Janssen finished the phase 3 trial, aiming to acquire regulatory approvals worldwide.

 

In South Korea, Handok seeks to enter the market with its acquired new drug.

 

HanAll Biopharma is conducting a Phase 3 trial and investigating the potential of commercialization.

 

According to industry sources on November 27, UCB's 'Zilbrysq' was approved in South Korea on November 21.

 

Zilbrysq can be used as an add-on to standard therapies, such as cholinesterase inhibitors, steroids, and immune checkpoint inhibitors.

 

This therapy is a complement C5 inhibitor and works by inhibiting the complement-mediated damage to the neuromuscular junction (NMJ).

 

Product photo of UCB

Due to this approval, Zilbrysq became the first treatment that can be self-administered, unlike other domestically approved treatments for adult myasthenia gravis.

 

'Ultomiris,' a complement C5 inhibitor used to treat existing myasthenia gravis, is an intravenous injectable that requires administration at hospital visits every 8 weeks.

 

Generalized myasthenia gravis (gMG) is a chronic autoimmune rare disease in which nerves fail to transmit signals to muscles, leading to skeletal muscle weakness.

 

This disease induces fluctuating weakness of systemic muscles, affecting daily activities such as standing, swallowing, and breathing.

 

Zilbrysq's approval is based on the Phase 3 'RAISE' study.

 

The study evaluated the efficacy and safety of Zilbrysq in 174 adult patients with anti-acetylcholine receptor (AchR) positive gMG.

 

The primary endpoint was the 'Myasthenia Gravis-Activities of Daily Living (MG-ADL)' for gMG.

 

Typically, an MG-ADL score of 2 or higher or a Quantitative Myasthenia Gravis (QMG) score of 3 or higher indicates clinically significant improvement.

 

The clinical results showed that the Zilbrysq group showed a clinically significant reduction by a total score of 4.39 from baseline at 12 weeks compared to the score of 2.30 of the placebo group.

 

In addition to working on Zilbrysq, UCB is preparing to expand approvals of 'Rystiggo,' UCB's additional treatment for myasthenia gravis, in countries.

 

Rystiggo obtained the U.S.

 

Food and Drug Administration (FDA) approval in June 2023 and was also approved in Europe in January of this year.

 

Janssen has recently completed the Phase 3 trial of 'nipocalimab,' a new drug candidate for myasthenia gravis and the company is preparing to obtain approval.

 

Janssen applied to obtain approvals from the FDA in August and the European Medicines Agency (EMA) in September.

 

Nipocalimab works by a novel mechanism that blocks the Fc receptor (FcRn), a protective immunoglobulin G (IgG) receptor.

 

This mechanism reduces IgG antibodies that cause the disease and inhibits their recycling process.

 

Nipocalimab binds to FcRn to prevent the degradation of IgG antibodies.

 

The Phase 3 Vivacity-MG3 study demonstrated the efficacy of nipocalimab in combination with standard therapy compared to the placebo.

 

The clinical study confirmed a statistically significant result, with nipocalimab recording an MG-ADL score of 4.70.

 

Also, nipocalimab improved the myasthenia gravis patients' muscular strength and function compared to the placebo.

 

Handok·HanAll aim to commercialize their treatments with a similar mechanism to nipocalimab

In South Korea, Handok is preparing for the new drug approval for the treatment of myasthenia gravis.

 

In August.

 

Handok signed an agreement with argenx, the Belgium-based developer of Vyvgart.

 

Handok is now responsible for domestic approval registration, applying for reimbursement, and exclusive distribution.

 

Like nipocalimab, Vyvgarth is a new drug targeting the FcRn.

 

It has been approved in several countries, including the United States, Europe, the United Kingdom, Israel, and China, for treating adult patients with generalized myasthenia gravis.

 

The clinical efficacy of Vyvgarth was demonstrated in the Phase 3 clinical trial named ADAPT.

 

It was shown that Vyvgarth recorded a 68% responder rate based on the MG-ADL scale, significantly higher than the 30% of the placebo.

 

Additionally, Vyvgarth demonstrated an improved score compared to the placebo group on the QMG scale.

 

HanAll Biopharma is also developing an FcRn antibody treatment candidate, batoclimab (HL161), as a subcutaneous injectable.

 

In December 2023, HanAll Biopharma's Chinese partner, Harbour BioMed, secured Phase 3 clinical trial results and submitted an approval application to Chinese regulatory authorities.

 

Harbour BioMed said that batoclimab improved symptoms in myasthenia gravis patients based on MG-ADL and QMG scales.

 

HanAll Biopharma is conducting a phase 3 trial for batoclimab in the United States.

 

HanAll Biopharma's U.S.

 

partnering company Immunovant finished registering patients for the Phase 3 clinical for myasthenia gravis.

 

Immunovant plans to present top-line results of the phase 3 clinical trial in the first half of 2025.

 

HanAll Biopharma and Immunovant plan to investigate the potential of batoclimab for various autoimmune disease indications, including thyroid eye disease and chronic inflammatory demyelinating polyneuropathy.

 

In addition to developing batoclimab, both companies will develop new drugs for additional myasthenia gravis indication.

 

HanAll Biopharma and Immunovant are conducting a phase 1 trial of IMVT-1402, a new FcRn antibody drug candidate product.

 

Unlike conventional FcRn antibody treatments, IMVT-1402 is not known to affect the LDL-cholesterol level.

 

In the Phase 1 clinical trial, subcutaneous injection of IMVT-1402 and placebo are administered to randomized healthy adults.

 

Each patient group receives a single-dose or multiple doses with a dose-escalation.