Kezar scarred as mid-phase autoimmune blowup raises doubts about pipeline-in-a-drug vision

Kezar scarred as mid-phase autoimmune blowup raises doubts about pipeline-in-a-drug vision

Kezar’s view of zetomipzomib as the only drug to control Kezar’s inflammatory disease was considered as an intermediate-stage placebo was hit in a clinical trial for rare autoimmune diseases, which caused the stock to drop.

Kezar introduced zetomipzomib, also known as KZR-616, as a pipeline into a drug because inhibition of the immune proteasome was believed to provide a way to go beyond treating inflammatory, single-celled, or cytokine diseases at the time. Today, Humira AbbVie acts on TNF-alpha, Actemra Roche on IL-6, and so on. from cells and cytokines involved in inflammatory diseases. Kezar sees zetomipzomib as a way to target several cells and cytokines through a single molecule.

The theory that zetomipzomib can restore normal immune responses without changing immunity and multiple inflammatory factors Tuesday night revealed that Kezar revealed the prospect of an inability to move the needle in Phase 2 clinical trial. 25 patients with dermatomyositis or polymyositis, a rare autoimmune disease characterized by muscle inflammation.

Participants received weekly subcutaneous zetomipzomib or placebo for 16 weeks before switching to the other arm for another 16 weeks. At week 16, the zetomipzomib arm had a mean change of 25.5 on a composite score by looking at measures such as muscle strength, compared with a change of 25 in the placebo cohort. At week 32, the changes for zetomipzomib and placebo were 32.5 and 31.3, respectively.

As zetomipzomib failed to catch up with placebo, the future of the drug researcher in both rare indications is uncertain. However, Kezar still sees promise in another disease, highlighting the lack of safety warning signs in the Dermatomyositis and Polymyositis clinical trial as positive, citing a reduction in key data from his MISIN phase 2 lupus nephritis study. in June.

“We are inspired by the favorable safety data and continue to firmly believe in the promise of zetomipzomib in lupus nephritis and our commitment to the development of this new compound in autoimmune diseases. The high response rates we’ve seen to date for MISSION – using objective endpoints in LN patients – support this belief, ”Kezar CEO John Fowler said in a statement.

Investors saw the darker news, causing Kezar’s stock to drop more than 30% to around $ 8.50.

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