Tuesday, February 1, 2022

Cardio-Vascular Arena Continues To Confound Even The "Best And Brightest": Pfizer / Ionis Edition, This Morning...


Back to the power-alley, then -- on a sunny Tuesday. Making meaningful gains, in the cardiovascular arena, without engendering excessive off-target effects. . . has been a long, slow and pock-marked journey through a back-country bramble -- since the early 1970s, essentially.

One more ditch, in the backwoods was seen, this morning -- as Pfizer and Ionis decided to stop pursuing the candidate called vupanorsen -- due in no small part to off target effects, depsite some decent efficacy, in reducing CV risks. Here's that press release / story -- and a bit:

. . .[Pfizer and Ionis] today announced the discontinuation of the Pfizer-led clinical development program for vupanorsen, an investigational antisense therapy that was being evaluated for potential indications in cardiovascular risk reduction and severe hypertriglyceridemia (SHTG). . . .

As previously announced, the study met its primary endpoint, achieving a statistically significant reduction in non-high density lipoprotein cholesterol (non-HDL-C) — as well as statistically significant reductions in triglycerides and angiopoietin-like 3. However, the magnitude of non-HDL-C and TG reduction observed did not support continuation of the clinical development program for CV risk reduction or SHTG. Vupanorsen was also associated with dose-dependent increases in liver fat, and higher doses were associated with elevations in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

Pfizer will return development rights to vupanorsen to Ionis, from which it licensed the investigational therapy in a worldwide exclusive agreement in November 2019. . . .


In closing I would note that at least the mega-cap pharmacos, post Martin and Elizabeth (and Fred!) almost never try to hype announcements like this, or try to spin them into positives, any longer -- preferring now (for over a decade), to just set out the facts, as they know them. This is in stark contrast to the 2008-era "Fast Fred" Hassan school of thought. And the world is better for the death of mega-pharma hucksterism (think Vytorin, here), in my view.

So, onward -- ever onward. . . into the cool sunshine -- albeit with perhaps seven new inches expected overnight, here.

नमस्ते

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