AstraZeneca shuts the PhIII door for Ionis' PCSK9 drug despite positive PhIIb
23 Sep 2022
When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”
But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.
Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”
Preview
Source: Endpts
“While the LDL-C reductions seen in high-risk hypercholesterolemia patients on maximum statin therapy were both statistically significant and robust, these results did not meet AstraZeneca’s target product profile criteria to invest in a broad Phase 3 development program,” said Eugene Schneider, EVP and chief clinical development officer at Ionis.
Like the previous ETESIAN trial, SOLANO tested a monthly subcutaneous dose of AZD8233 in patients with hypercholesterolemia — but tested only one dose, 60 mg, rather than three in ETESIAN. It also followed patients for longer.
After 28 weeks, the drug spurred a statistically significant 62.3% (p
The companies did not reveal the effect on PCSK9 levels.
It’s unclear what AstraZeneca was looking for. Praluent, the first-generation PCSK9 blocker on the market, lowers LDL-C by only around 50%. The same goes for Novartis’ Leqvio, which boasts of a six-month dosing interval. But the treatment of patients suffering from high cholesterol levels despite statin remains a crowded commercial space, with players big and small vying for market entry.
The pharma giant is still analyzing the results and will determine the next steps later, it added.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
Chat with Hiro
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.