Don’t Get Dizzy! Milestone Pharma to Release Trial Results Soon

featured-image
Etripamil will be an inhaled drug for tachycardia. DepositPhotos

Imagine being in the middle of a grocery store when all of a sudden, out of the blue, your heart starts racing and won’t stop. You get dizzy and feel like you might pass out. This condition, known as tachycardia, is caused by an electrical problem in your heart that causes a misfire and can send your heartbeat up to 250 beats per minute (an average heartbeat is between 60-100 beats per minute).

A Canadian company named Milestone Pharmaceuticals $MIST is working on a treatment for this condition, and they have Phase 3 drug results coming out in the middle of the first half of 2020.

A video showing what it’s like to live with Tachycardia

The Drug With the Catalyst

For people who get chronic tachycardia attacks, current options are not great. If you head to the emergency room, a doctor may give you an intravenous injection of adenosine, but you’ll also get an emergency-room-sized bill. If problems persist, doctors may recommend a catheter ablation, where heat or cold is used to destroy heart tissue (ouch). Wouldn’t it be much better if there were a treatment that was immediate and fast-acting when tachycardia strikes?

Milestone’s drug, named etripamil, promises to be both fast-acting and used only when needed. The drug is a nasal spray, and it is intended to be used much like an asthmatic uses an inhaler, to control a sudden attack.

The drug is a calcium channel blocker.

How Etripamil may be used. Picture from Milestone’s Investor Presentation.

Milestone is currently running a Phase 3 study of their drug, Etripamil, with 500 patients, with results due out in the first half of 2020. They are also planning on testing the drug for atrial fibrillation and angina.

Clinical Pipeline for Etripamil, from Milestone’s website.

History of the Company

Milestone Pharmaceuticals is a Montréal, Québec company founded in 2003 to develop drugs for cardiovascular diseases. The company IPOed in May 2019 at $15, and while the stock has bounced between $15 and $25 for the past year, the company itself has been mostly devoid of big stock-moving events. Here’s a run-down.

1 year annotated chart of MIST
  1. Milestone IPOed at $15/share
  2. Analysts weigh-in, with the firms Piper Sandler, Cowen, Jefferies, and Oppenheimer all rating the company a buy, with one-year price targets between $26 – $32.
  3. Analysts at firm Piper Sandler write they expect a positive outcome from Milestone’s drug results, and they expect an FDA approval in 2023.

Upcoming Phase 3 Drug Results

Milestone is currently running a Phase 3 clinical study, called NODE-301, with 500 patients. The goal is to determine if etripamil is better than a placebo in terminating PSVT (Paroxysmal supraventricular tachycardia – a type of tachycardia) events.

The upcoming drug results are a big deal for Milestone Pharmaceuticals, as etripamil is the company’s only drug and tachycardia is its main indication. This is setting up for a binary event in the stock depending on these results. Research firm Cowen estimates that a positive Phase 3 result could give a 200% upside, and a failure could see an 80% downside. Here is @SyInvesting quoting Cowen’s research.

So will the Phase 3 trial be a success? The Phase 2 study, testing 105 patients with PSVT looked strong. The higher the dosage, the more patients the drug worked in. Here is a chart from the company showing dosage vs effectiveness in the Phase 2 trial.

Phase 2 data from Etripamil, showing the higher the dosage, the more patients the drug worked in. Taken from Milestone’s investor presentation.

However, with any drug, we must also consider safety. Calcium channel blockers like etripamil have undesirable side-effects like hypotension (low blood pressure). Milestone is trying to test a dosage that is effective enough to stop tachycardia but not high enough to cause hypotension. Below is a conversation on Twitter between @WhiteWharf and @JuggernautCap about the pros and cons of owning Milestone into this event.

Summary

Milestone Pharmaceuticals has a big binary event coming. As etripamil is the company’s only drug, success in the Phase 3 trial could mean a huge move to the upside or a major stock crash. Opinions on Twitter are generally bullish, but all eyes will be on drug safety.

TakeAway

  • Stock: Milestone Pharmaceuticals $MIST
  • Phase 3 Drug Results Due: Middle of the first half of 2020
  • Catalyst Score: 5/5

Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 24 hours. This article is for informational purposes only, and while the author makes every effort to present accurate and reliable information, Foreshadow, LLC does not guarantee the accuracy, completeness, efficiency, timeliness, or correct sequencing of such information.  Reliance on such information should only be undertaken after an independent review of its accuracy, completeness, efficiency, and timeliness. This article is not intended to serve as a recommendation to buy or sell any security. The author is not a registered investment advisor.

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