Hanall Biopharma to expand HL161 development in earnest

Partner Imunovant unveils development plan

Last year's suspension of thyroid eye disease resumed in the second half of clinical trials

Seeking additional indications

Hanall Biopharma announced on the 9th that its U.S.

 

partner Imunovant will expand the development of HL161 (code name IMVT-1401), which is being developed as a SC autoimmune treatment.

 

Phase 3 clinical trials for severe work history will begin this month and the results of the top line in 2024 will be confirmed.

 

According to Immunovant, there are estimated to be about 66,000 patients with severe work history in the United States.

 

Clinical plans for TED, which were suspended last year, have also been unveiled.

 

Immunovant obtained consent from the U.S.

 

Food and Drug Administration (FDA) for phase 3 clinical trials of HL161.

 

Phase 3 clinical trials are expected to begin in the second half of this year and confirm the results in 2025.

 

Imunovant also unveiled a plan to further expand the indication of HL161 to provide wider treatment options for patients suffering from intractable diseases.

 

By August, three indications, including WAIHA, will be added and phase 3 clinical trials will be launched for one of them.

 

HL161 is the U.S.

 

and European development name of the new antibody drug HL161, which Hanall Biopharma exported to Roivant Sciences in December 2017.

 

It exhibits a mechanism of action to remove pathogenic autoantibodies in the body by inhibiting the 'FcRn' receptor known as the cause of autoimmune diseases.

 

Roivant Sciences has signed a total of $52.5 million contract with Hanall Biopharma on condition that it secures exclusive rights to develop, produce, item licenses, and sell autoimmune disease HL161 in the U.K., Switzerland, the Middle East and North Africa, including the U.S.

 

At the time of the contract, it paid $30 million in deposit (upfront fee), which was not obligated to return, and additional $20 million in research funds and $452.5 million in step-by-step milestones (technical fees).

 

Imunovant decided to voluntarily suspend clinical trials early last year on the grounds that a rise in total cholesterol and LDL-C levels was observed in the HL161 administration group among patients participating in clinical trials 2b.

 

Chung Seung-won, CEO of Hanall Biopharma, said, "HL161 is expected to reduce the burden of medical expenses because it is convenient for patients to take drugs on their own in the form of subcutaneous injections." "We will continue to expand the indication of HL161 to contribute to the lives of more patients," he said.