Daily Newsletter

31 August 2023

Daily Newsletter

31 August 2023

Alpine initiates second cohort dosing in trial to treat glomerulonephritis

No serious severe adverse events and instances of hypersensitivity were observed with repeat dosing of povetacicept.

August 31 2023

US-based Alpine Immune Sciences has initiated dosing in the second IgA nephropathy (IgAN) cohort using 240mg povetacicept (ALPN-303) in the Phase Ib/IIa RUBY-3 study to treat autoimmune glomerulonephritis.

Dosing is initiated based on the positive data from the first IgAN dose cohort which received 80mg povetacicept subcutaneously once every four weeks.

The Safety Monitoring Committee reviewed the data and found it to be safe and well-tolerated.

No severe adverse events and instances of hypersensitivity or administration-related reactions were observed with repeat povetacicept dosing in the first cohort.

In addition, there were no events of hypogammaglobulinemia (IgG < 3g/L).

Alpine Research and Development head and president Stanford Peng said: “We are encouraged by this first in-disease experience with the lowest dose level of povetacicept in this study, confirming its initial safety and pharmacodynamic activity during multiple dose administration.

“We look forward to providing more detailed clinical updates later this year in appropriate scientific forums.”

The company started enrolling patients for the second cohort in its open label, multi-cohort, multiple ascending dose study.

The study is also intended to treat patients with primary membranous nephropathy, and lupus nephritis. They will receive povetacicept subcutaneously for up to 48 weeks.

Key endpoints of the study include proteinuria, renal response, eGFR, and disease-related autoantibodies.

Povetacicept is a dual antagonist of the B cell activating factor (BAFF) and a proliferation inducing ligand (APRIL) cytokines.

Greater potency of povetacicept was demonstrated in preclinical studies against wild-type TACI-based comparators and other inhibitors of BAFF and/or APRIL alone.

Povetacicept is also in development for treating systemic lupus erythematosus, and autoimmune cytopenias.

mRNA vaccines represent >40% of the authorized/approved COVID-19 vaccines and boosters in the 7 major pharmaceutical markets

There are currently 13 authorized/approved COVID-19 vaccines in the 7 major pharma markets. Currently, vaccine developers plan to launch updated boosters prior to the upcoming 2023 fall season to target the latest dominant strain, Omicron XBB.1.5. Per GlobalData analysis, mRNA vaccines will likely continue to dominate the market, though as the pandemic winds down, the global COVID-19 vaccines market is expected to decline.

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