Vertex Pharmaceuticals has announced that it will acquire clinical-stage biotech, Alpine Immune Sciences (ALPN), for US$4.9bn (A$7.5m), representing US$65 per share. ALPN shares were trading at ~US$35 last week prior to media reports of a potential takeover, having risen from US$11 just 6 months ago.
Alpine Immune’s lead asset is povetacicept, a protein based immunotherapy, with its most advanced indication being IgA nephropathy (IgAN). A Phase 1/2 open label MAD trial in 56 patients with four different Autoimmune Kidney Diseases, including IgAN, commenced in March last year and Alpine had recently completed a 36 week review of the IgAN cohort.
Povetacicept, a once monthly subcutaneous injection, was well tolerated in the IgAN cohort and demonstrated “deep and clinically meaningful reductions in UPCR and Gd-IgA1 with stable eGFR and resolution of hematuria” at 36 weeks. Alpine has already had a successful end of Phase 2 meeting with the FDA and intends to commence a pivotal Phase 3 trial in the second half of this year. There are also plans to advance povetacicept into Phase 2 studies of the other indications.
An estimated 125,000 patients in the U.S. have IgAN. While several therapies are approved to treat symptoms, none yet target the disease’s cause.
By way of comparison, ADPKD is estimated to affect approximately 300,000 people in the U.S., with 80-85% of cases caused by mutation in the PKD1 gene, which is the target of PYC-003.
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