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JPM23: Ionis CEO admits PCSK9 ship captained by Big Pharmas may have sailed

2023-01-11

临床3期临床2期

Ionis CEO Brett Monia, Ph.D., is still hopeful about tofersen's approval chances as the clinical prospects of two other meds head in different directions.

Ionis Pharmaceuticals once had AstraZeneca involved wtofersenspied a bright future for PCSK9 inhibitor ION449. Now, after the U.K. pharma backed out last year, CEO Brett Monia, Ph.D., thinks the drug may have missed its shot.

Ionis Pharmaceuticalsmatch for AstraZeneca forward through development,” Monia said in PCSK9terview witION449ce Biotech Wednesday morning ahead of the company’s presentation at the J.P. Morgan Healthcare Conference. “The investment in phase 3 is massive.”

MPCSK9said the therapy will be hard to partner again due to the competition in the field and the strenuousness of planning a phase 3 trial. The reason for that, Monia explained, is that you likely need to conduct a cardiovascular outcomes trial to get payers to rally behind the drug. That’s time and money the company doesn’t want to put up. He added that a head-to-head comparison trial would also likely be needed to really win over the market.

AstraZeneca elected to walk away from ION449 in November after getting a look at phase 2b data in patients with hypercholesterolemia. If Ionis can’t find another partner, it’s likely to fall out of the pipeline.

AstraZenecais a good-looking drug, it ION449robably came a little bit too late to the game,” Monia said. The druhypercholesterolemiaherapIonisuch as Sanofi and Regeneron's Praluent and Amgen's Repatha.

It’s a different story for fesomersen, which was returned to Ionis from Bayer after being tested in patients with end-stage renal disease. Monia saysSanofithereRegeneronreaPraluentrest Amgene factor XI drug compared to ION449, given the quality of the drug and market competitiveness.

Although Ionis has receivedfesomersennterest, Monia said locking up a neBayertnership this quarter would be too agend-stage renal diseasegiven the med was just returned in the third quarter offactor XI drug ION449

“PartnersIonislike these have a gestation period of usually about a year,” he said.

The diverging paths of ION449 and fesomersen come as Ionis is bracing for three new commercial products, furthering Monia’s goal of making Ionis a fully integrated biotech company rather than a licensing behemoth.

Included among the three is tofersen, a Biogen-partneIonisreatment for SOD1 amyotrophic lateral sclerosis. The FDA action date was pushed bIonisn October 2022 from late January to late April, and an advisory committee meeting has not yet been scheduled, although Monia says he’s expecting and hoping for one.

The drug failed a phase 3 trtofersen021,Biogenncluded in the approval aSOD1 amyotrophic lateral sclerosising clFDAcal improvements and better quality of life when tofersen was administered earlier.

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Ionis