Gilead starts trial for its autoimmune disease drug in KOR

MFDS approves Phase Ib trial...first clinical trial in Asia following trials in the U.S. and U.K.

The B- and T-Lymphocyte Attenuator (BTLA) autoimmune disease treatment will enter clinical trials in Korea.

 

The Ministry of Food and Drug Safety approved Gilead Sciences' application for a ‘multicenter, randomized, placebo-controlled Phase 1b clinical trial to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of multiple ascending doses of GS-0272 in adult participants with rheumatoid arthritis.’ The trial will be conducted at Chungnam National University Hospital, Seoul National University Hospital, and Ajou University Hospital.

 

Gilead has been conducting a Phase I trial on GS-0272 since September 2023 in the United States, Georgia, Moldova, and the United Kingdom.

 

The global phase I trial will run until June next year, and Korea will participate for 6 months from this month.

 

The global Phase 1 will enroll 87 patients worldwide, including 8 in Korea.

 

The Phase 1 study of GS-0272, which evaluates the safety and tolerability of multiple doses in patients with rheumatoid arthritis, aims to evaluate the safety and tolerability of multiple ascending doses of GS-0272 in patients with rheumatoid arthritis and to characterize the pharmacokinetics of GS-0272 after multiple doses.

 

BTLA agonists are drugs that treat autoimmune diseases caused by an overreaction of immune cells by enhancing BTLA's ability to inhibit the activity of B or T cells.

 

They are used to treat autoimmune diseases caused by an overreaction of immune cells, and unlike conventional autoimmune disease treatments, they do not target just B or T cells.

 

This dual mechanism of action that targets both cells simultaneously is expected to make autoimmune diseases more effective.

 

In addition to Gilead, other BTLA agonists currently in development include ANB-032 from Anaptysbio in the U.S.

 

and HFB-200603 from HiFiBiO Therapeutics in France.

 

Eli Lilly discontinued its Phase 2 clinical trial for lupus, an autoimmune disease, due to the lack of efficacy of its BTLA agonist antibody.

 

Lilly had hoped that activating BTLA to target autoimmune diseases would be a novel approach, but the company abandoned the program after failing to achieve clinical success in psoriasis and lupus.