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Message: Re: ESPR

Koo,

Sorry I was so late in responding to your ESPR message. I don't look at the off topic forum too often. Next time, if I don't answer you please send me a private message letting me know.

I still think that Esperion's ETC-1002/bempedoic acid will eventually pass Phase 3 and become a solid LDL-lowering therapy. It has proven itself effective and safe in a large number of phase 2 trials; however, no trial has been longer than 12 weeks.

Esperion just put out a news release today with some general timelines. From this news release, they state that the current Phase 3 CLEAR study is currently operating as a 52-week long-term safety and tolerability study, but later in the news release they state that in "Q4 2016: Esperion plans to initiate the Phase 3 CLEAR clinical efficacy studies for bempedoic acid in statin intolerant patients." To me, this sounds like the CLEAR study will be amended at some point to include more efficacy endpoints. On clinicaltrials.gov, it currently lists the CLEAR trial is enrolling 900 patients with an estimated completion date of December 2017.

Also in the news release, Esperion plans to initiate in Q4 2016 a cardiovascular outcomes trial (CVOT) for ETC-1002/bempedoic acid in statin intolerant patients. Will this be an add on to the current Phase 3 CLEAR study or a completely new Phase 3? Most CVOTs are at least 2 years long, so if this is going to be a new Phase 3 independent of CLEAR then I'm guessing that we are looking at 2019 at the earliest for this CVOT trial to be completed (assuming 2 year length initiating in Q4 2016 or Q1 2017). However, if they can adapt the current Phase 3 CLEAR to also be a CVOT, then this would save some time. It is doubtful that the 900 patients in the current Phase 3 CLEAR trial would be enough for a CVOT trial, which normaly enrolls thousands of patients. They also have a Phase 1 and Phase 2 trial going on right now that should give results in Q3 2016. I doubt that these Phase1/Phase2 trials will move the stock, since ETC-1002 has already proven its safety and efficacy in other short-term trials.

"Esperion plans to announce top-line results from the Phase 2 PK/PD clinical study of bempedoic acid in patients treated with high-dose atorvastatin (1002-035) and top-line results from the Phase 1 clinical pharmacology study to assess the safety and tolerability of bempedoic acid and PK of the highest doses of the most commonly prescribed statins (1002-037)."

Back to your question: Will ESPR see $122 again? As I write this, they are sitting at ~$14 USD, which was their original IPO price about 3 years ago. And right now their market cap is just over $300 M. In my opinion, we will need to wait for the CLEAR study to finish up around December 2017 or afterwards for much movement to happen. However, I could be completely off here. ESPR share price was hammered not because of bad results, but because of the market's reaction to Esperion's dealings with the FDA and to the approval of another statin-alternative (the anti-PCSK9 antibody therapies).

One of their upcoming milestones is: "Q3 2016: Esperion plans to announce details of the cardiovascular outcomes trial (CVOT) for bempedoic acid in statin intolerant patients." This could potentially be a catalyst for ESPR. If the market perceives this CVOT information as positive, then we could see some significant share price movement.

Long story short, yes I think we will see $122 again. But most likely we will see gradual/incremental increases in the share price unlike the wild upswing from $14 to $122 before. I don't have a position in ESPR right now. I'm still on the fence, but I am always watching it.

BearDownAZ


May 24, 2016 11:04AM

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