Acasti reported that their first Phase 3 trial of Capre did not reach statistical significance due to an unusually large placebo effect. ACST is down 66%.
This news came after the highly anticipated Phase 3 data was initially supposed to come in December, but the company announced a last-minute delay. Now we can see why. They were trying to make sense of the placebo effect.
Acasti reported:
- At 12 weeks: Capre showed 30.5% reduction in triglyceride levels, compared to a 27.5% reduction for placebo arm (4% delta)
- At 12 weeks + background statin: Capre showed 42.2% reduction in triglycerides, compared to a 31.5% reduction for placebo arm (10.7% delta).
- At 26 weeks (end of trial): Capre showed a 36.7% reduction in triglyceride levels, compared to a 28.0% reduction for placebo (8.7% delta)
Underwhelming data. Obviously, the triglyceride level reductions in placebo group were far greater than expected, which brings up the question: why? Trilogy 1 enrolled 244 patients across 54 sites. The placebo arm used cornstarch, which is not expected to materially impact triglyceride levels. Coincidence seems like a longshot excuse.
In other TG trials ran by Amarin, AstraZeneca and GSK, the placebo responses (using corn oil, olive oil, or vegetable oil) ranged from a change of +16% to -17%. Nothing near Acasti’s ~-30% placebo response. See below.
Therefore, it most likely was a trial design flaw that includes patient selection and screening. This falls entirely on Acasti.
Acasti is undergoing a full investigation of the 54 sites, including review of all raw data and records from patients taking both CaPre and placebo to find the root cause of unprecedented placebo effect.
Results from the second Phase 3 trial (“Trilogy 2”) are expected mid-February.
What Does This Mean?
We think Acasti is dead in the water. Even with positive Trilogy 2 data in February, the company is facing headwinds. The FDA will likely need to see another study, which Acasti does not have the cash to fund. Additionally, any potential partner to Acasti will need to pour in hundreds of millions to fund a large CV study, similar to Amarin and AstraZeneca.
AstraZeneca Pulls Plug on Epanova CV Study
Coincidentally, this morning, AstraZeneca also prematurely ended their CV study that was competing with Amarin’s Vascepa. This leaves Amarin as the only player with no competitor in sight. It’s important to note that AstraZeneca’s failure also eliminates any argument for Omega-3 class effect. Data, thus far, is showing that only purified EPA (ie. Vascepa) is successful in reducing cardiovascular events.
Any chance smaller competitors, like Acasti and Matinas (MTNB), had to ride coat tails of Amarin has been diminished. There was one clear winner today and it was Amarin. We still think they have a good chance of being acquired by large pharma, even with the looming IP uncertainty.
PropThink contributors have no positions in any of the stocks mentioned.
Access This Content Now
Sign Up Now!
