Express | A new generation of CD20 antibodies reached the primary endpoint of two phase 3 clinical trials, significantly reducing the annual recurrence rate of MS disease

▎The content team editor of WuXi AppTec today, TG Therapeutics announced that its innovative glycoengineered anti-CD20 antibody ublituximab has reached the primary endpoint in two phase 3 clinical trials, significantly reducing multiple sclerosis (MS) compared with the active control group The patient’s annual disease recurrence rate (ARR).

Multiple sclerosis is a chronic demyelinating disease caused by the immune system attacking the myelin sheath that protects nerves.

There are more than 2.
8 million MS patients worldwide, and it is one of the leading causes of non-traumatic disability in young people.
Most patients have their first symptoms between the ages of 20-40.

Relapsing remitting MS (RRMS) is the most common type of MS disease, and 85% of initially diagnosed patients are of RRMM type.

Due to the repeated recurrence of the disease, the patient’s disability will continue to increase over time.

Ublituximab is an investigational monoclonal antibody targeting CD20.

By combining with the CD20 antigen on the surface of B cells, it can trigger a series of immune responses to destroy B cells.

These cells are considered to be the key factors leading to the damage of myelin sheath and nerve cell axons.

A unique feature of Ublituximab is that certain naturally occurring sugar molecules in anti-CD20 antibodies have been removed through bioengineering.

Through this glycoengineering treatment, the effectiveness of ublituximab is significantly enhanced.

In two randomized, double-blind, active-controlled phase 3 clinical trials named ULTIMATE I and ULTIMATE II, patients with relapsing MS received ublituximab or teriflunomide.

The test results showed that after 96 weeks of treatment, ublituximab reduced the patient’s annual recurrence rate to below 0.
10.Compared with the active control group, the annual recurrence rate was reduced by 60% and 49% respectively, reaching the primary endpoint of the trial.

▲Compared with the active control group, Ublituximab significantly reduced the annual recurrence rate of the disease in two phase 3 clinical trials (picture source: reference [2]) In addition, ublituximab also reached a series of secondary endpoints, reducing the number of brain lesions in patients , Delaying the progression of disability and other aspects also provide significant benefits.

▲Related reading: This disease has caused more than 2 million people to struggle in pain.
This monoclonal antibody wants to stop it, Mr.
Michael S.
Weiss, CEO of TG Therapeutics, said: "Our clinical trials on ULTIMATE I and ULTIMATE II I am very pleased with the results.

We believe that these data show that ublituximab is a highly effective treatment option with good safety characteristics.

We plan to submit a Biologics License Application (BLA) to the FDA in the third quarter of this year for the treatment of relapse Type MS patients.

"Reference: [1] TG Therapeutics Announces Positive Results from the ULTIMATE I & II Phase 3 Trials of Ublituximab in Multiple Sclerosis to be Presented at American Academy of Neurology 73rd Annual Meeting.
Retrieved April 16, 2021, from https://ir .
tgtherapeutics.
com/news-releases/news-release-details/tg-therapeutics-announces-positive-results-ultimate-i-ii-phase-3[2] ULTIMATE I & II Data Preview Call.
Retrieved April 16, 2021 , from https://ir.
tgtherapeutics.
com/static-files/c34533d2-f3e4-4c74-b2d9-f182407459ed Note: This article aims to introduce medical and health research progress, not a treatment plan recommendation.

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