Acasti Pharma Inc. (ACST) INITIATION REPORT November 25, 2019
. If the primary TG-lowering endpoints are met in both Trilogy studies, assuming an acceptable safety profile, there is a good probability that CaPre would be approved by FDA in 2021. The theoretical timing of a CaPre launch in 2021 is ideal, with the omega-3 market thriving due to the likely label expansion for Amarin’s Vascepa, based on the compelling REDUCE-IT study, and the possible commercial launch of AstraZeneca’s Epanova.
Even with an inferior label relative to Vascepa, and likely Epanova, we believe that CaPre can carve out a niche in what should be a vibrant omega-3 market.
The size of that niche will, in our opinion, be determined by attributes of CaPre beyond its TG-lowering capability. Specifically, these include whether CaPre demonstrates a meaningful impact on other lipid parameters (LDL, HDL) and / or HbA1c, which would allow Acasti, or a partner / acquirer, to create a differentiated omega-3 brand based on cardiometabolic attributes. Later in this report, we will outline how we envision CaPre competing as a commercial omega-3 product through analysis of best and base case scenarios. Although we are optimistic, assuming Ph3 clinical success, about CaPre’s commercial potential,
we recommend caution to investors heading into the first Trilogy readout in December. Acasti has run two Ph2 studies with CaPre - COLT and Trifecta - and, to be candid, we find these studies challenging to interpret, as they relate to the probability of CaPre meeting the primary TG-lowering endpoint in the Trilogy studies. It is apparent from both studies that CaPre reduces TG levels, although it remains unclear whether this is in a dose-dependent manner. Acasti has presented limited data on the 4g dose of CaPre being used in the Trilogy studies, and no data at all on how this dose has performed in patients with severe hypertriglyceridemia
We prefer the strategy of owning post-Trilogy I. This approach will provide investors with some clinical clarity and confidence, while still offering the potential upside of the Trilogy II readout, as well as secondary and exploratory data announcements. Significance of Cadance of Data
We assume that CaPre, like its omega-3 predecessors, will only need to demonstrate a statistical
benefit on TGs, which for the Trilogy studies
is defined as a difference of at least a 20%
reduction from baseline in TGs between
CaPre and placebo, in order to achieve FDA
approval.
https://encodelp.com/site/wp-content/uploads/2019/11/EI-Acasti-November-25-Initiation-Report.pdf
