Data for Alpine’s kidney disease candidate drive Vertex’s $4.9B takeover

2024-04-10

临床结果临床3期并购

Alpine Immune Sciences’ pivot away from cancer in 2022 has proven to be a profitable choice. After doubling down on its autoimmune and inflammatory disease pipeline, the biotech on Wednesday shared new data for its kidney disease programme — and announced a $4.9 billion buyout by Vertex Pharmaceuticals.

The rare diseases company agreed to shell out $65 per share to acquire Alpine, a 67% premium over its Tuesday close. Shares of the latter climbed about 21% on Wednesday following a Bloomberg report that the biotech was considering a sale, and jumped a further 37% in after-hours trading once that rumour was confirmed.

The takeout price is an even bigger bump from Alpine’s 2022 low of $5.45, when it discontinued development of its sole remaining immuno-oncology programme davoceticept following the death of a second patient due to cardiogenic shock.

Disease-modifying data

The main asset behind the acquisition is povetacicept, a dual BAFF/APRIL antagonist in mid-stage testing for IgA nephropathy (IgAN), a progressive, autoimmune disease of the kidney that has no approved disease-modifying therapies. Because the two cytokines targeted by povetacicept play key roles in the activation, differentiation, and survival of several types of immune cells, the hope is that the therapy can disrupt autoimmune disease pathogenesis.

Alpine shared updated data on Wednesday from the RUBY-3 Phase Ib/IIa study of povetacicept that seem to support that theory.

The open-label trial enrolled 41 patients with IgAN to receive either an 80mg or 240mg subcutaneous dose of povetacicept every four weeks. Those who received the smaller dose saw a clinically meaningful improvement in proteinuria, including a 64.1% reduction from baseline in urine protein to creatinine ratio at 36 weeks. Of six measurable patients on the 80mg dose, four (67%) achieved remission and stable renal function.

According to Alpine, initial data for the 240mg dose show a similar trend of improvement in proteinuria, stable renal function, and remission in 13 patients with 12-week data available, and two patients with 24-week data.

Both low- and high-doses also achieved significant reductions in disease-related biomarker Gd-IgA1 of 68.9% at 40 weeks, and 78.6% reduction at 20 weeks, respectively. The two doses were well tolerated with no severe infections.

“These data strongly support the inhibition of APRIL/BAFF pathways by povetacicept and its efficacy in the treatment of IgAN as well as the need for further clinical development. If approved, povetacicept could be used as a front-line disease modifying treatment in IgAN,” said James Tumlin, a professor of medicine at Emory University School of Medicine and the founder and CEO of NephroNet Clinical Trials Consortium.

‘Pipeline-in-a-product’

Povetacicept adds to Vertex’s growing renal portfolio, which includes two clinical programmes: inaxaplin to treat APOL1-mediated kidney disease APOL1-mediated kidney disease, and VX-407 for autosomal dominant polycystic kidney disease.

“Alpine is a compelling strategic fit for Vertex and furthers our ambition of using scientific innovation to create transformative medicines targeting serious diseases with high unmet need in specialty markets,” said Vertex CEO Reshma Kewalramani. “We also look forward to fully exploring povetacicept’s potential as a ‘pipeline-in-a-product' and adding Alpine’s protein engineering and immunotherapy capabilities to Vertex’s toolbox.”

In addition to launching a registrational Phase III trial of the candidate next half in IgAN, Vertex plans to further explore povetacicept in other autoimmune diseases such as membranous nephropathy, lupus nephritis, and autoimmune cytopenias; an open-label Phase I/II study is already underway for the latter indication.

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