Milestone procures $80M to fund at-home phase 3 trial of tachycardia rescue nasal spray

Bringing It Home

Etripamil, a “short-acting calcium channel blocker being developed for paroxysmal supraventricular tachycardia, or PSVT, where the heart can beat over 200 times per minute,” is certainly exciting investors, according to an article by Conor Hale in Fierce Biotech. Milestone Pharmaceuticals of Montreal, Canada, has raised $80 million to fund its lead program, an at-home, phase 3 clinical trial of its nasal spray for rapidly reducing super high heart rates.

Although the condition is not life-threatening in and of itself, it can trigger great distress and anxiety in patients. In addition, it can be responsible for trips to the emergency room and the use of intravenous drugs to calm the heart. Such drugs might include adenosine or verapamil, a channel blocker that has the same mechanism of action as etripamil. According to Milestone, PSVT occurrences can lead to upwards of 600,000 claims in the U.S. per year.

According to Hale’s article, new backer RTW Investments led the equity financing round, supported by Venrock Healthcare Capital Partners and Tavistock Group’s Boxer Capital. There were returning investors -- Novo Holdings, Forbion, Domain Associates, BDC Capital, Pappas Capital, GO Capital, Fonds de solidarité FTQ and funds run by Tekla Capital Management. Novo Holdings led the company’s $55 million series C round in 2017.

New funding will help to finance the outpatient phase 3 study, which enrolled its first patient in July, and a second phase 3 safety study Milestone targeted for 2019. Milestone, which has 20 employees, also plans to expand its commercial, medical affairs, patient advocacy and late-stage development teams.

Milestone is also planning to run signal-finding studies in additional indications for the etripamil spray, including atrial fibrillation or stable angina. Because etripamil has an effective half-life of approximately 25 minutes, Milestone believes it is a safer alternative to IV drugs, as well as having the advantage of portability.

According to CEO Joseph Oliveto, the ongoing trial’s design is a “paradigm shift for PSVT investigations,” because patients are being sent home with the drug and a small cardiac monitor and waiting for an event to occur. ‘After self-administering the drug, the cloud-based ECG will aim to capture the conversion from tachycardia to a normal sinus rhythm, and then send the data back to researchers,” he explained. “It's a unique way of treating these episodes in the at-home setting, and groundbreaking in terms of how we're going to do this trial.”

Milestone hopes for about 500 participants and at least 100 events. The company is waiting about four to five months before making projections on timelines for completion or regulatory submissions.

Eventually, this at-home drug could be linked with at-home devices, including the latest version of the Apple Watch with a built-in ECG or other wearable devices from AliveCor and Fitbit. Oliveto thinks his company will be hitting commercialization at the right time for that. Such data could help physicians to better diagnose the condition, when heart rates can return to normal before the patient gets to an emergency room or doctor’s office.

Oliveto concluded, “We really want to partner with these companies that are at the forefront developing these wearables, and we're in that process now as we're getting into phase 3.”