Horizon Acquires Viela, Will Develop Inebilizumab for MG Symptoms

In a $3.05 billion deal, Horizon Therapeutics will acquire Viela Bio, the developer of inebilizumab, a potential treatment for autoimmune diseases such as myasthenia gravis (MG), the two companies announced.

Horizon plans to advance inebilizumab, already approved for treating another rare autoimmune disease, as a therapy for decreasing disease activity and easing symptoms in MG and other disorders, the companies said in a press release.

“Adding Viela’s research and clinical development capabilities along with its deep, mid-stage biologics pipeline to our seasoned R&D and commercial teams, advances our transformation to an innovation-driven biotech company,” said Tim Walbert, chairman, president, and CEO of Horizon.

“We intend to maximize the full potential of Viela’s pipeline, including the pursuit of additional future indications,” Walbert added.

Inebilizumab is a monoclonal antibody that binds to a protein called CD-19, found on the surface of immune B-cells. The therapy was designed to deplete these cells, which play a central role in the progression of autoimmune diseases like MG.

In MG, B-cells produce self reactive antibodies self-reactive antibodies, called autoantibodies, that impair the communication between nerves and muscle cells. Most notably, these autoantibodies target proteins called acetylcholine receptor (AChR) and muscle-specific kinase (MuSK).

By killing B-cells, inebilizumab may lessen the production of autoantibodies and, as such, decrease disease activity and the associated symptoms. The therapy is currently being investigated in people with MG in a Phase 3 clinical trial (NCT04524273) that is now recruiting participants in Columbia, Md.; another trial site is in Houston. More information and trial contacts are available here.

The Viela-sponsored trial aims to enroll 252 people with MG who have autoantibodies against AChR or MuSK and who have at least some functional impairment, as assessed with measurements such as the Myasthenia Gravis Activities of Daily Living (MG-ADL). Participants will be randomly assigned to receive either inebilizumab or a placebo, given intravenously (into the vein) on days 1, 15, and 183 of the trial.

The study’s primary goal — its main measurement of efficacy — is a change in the MG-ADL scores. Other measurements to assess disease also will be employed, and safety goals will be evaluated. The trial’s timeframe is about a year for individuals with anti-AChR autoantibodies, and about six months for those with anti-MuSK autoantibodies.

In the U.S., inebilizumab is currently approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) under the brand name Uplinza. NMOSD is an autoimmune disease that primarily affects the eyes.

In addition to MG, the medication is being developed as a potential treatment for IgG4-related disease — a group of disorders characterized by tumor-like swelling and scarring of organs — and to aid in kidney transplants.

Viela also had been developing several other investigational medications that aim to treat diseases involving the immune system, as well as COVID-19.

“We are pleased that Horizon recognizes the value of our robust R&D pipeline, our commercial medicine UPLINZA, which is an important treatment option for patients with NMOSD, and our talented team,” said Bing Yao, PhD, Viela’s chairman and CEO.

“We believe that the combined pipeline, including the pursuit of additional potential indications, has the potential to yield innovative new medicines to treat autoimmune and severe inflammatory diseases. Our collective R&D expertise coupled with Horizon’s commercial capabilities, has the potential to provide benefit to more patients with high unmet treatment needs,” Yao said.

As part of the acquisition, Horizon will be purchasing all of the issued and outstanding shares of Viela common stock for $53 per share. The deal is expected to be completed by the end of the first quarter, the companies said.