Startups, Venture

Milestone Pharma preps a leap into PhIII cardio study with $55M round backed by Novo

A little more than two months after scoring the proof-of-concept data that he was looking for, Joe Oliveto is steering Milestone Pharmaceuticals into a Phase III efficacy study that will put their one and only drug to a pivotal test. And he has a $55 million round led by Novo to pay for it.

Joe Oliveto

Milestone, based out of Quebec with a satellite office in North Carolina, where the CEO lives, has kept the crew small and focused. The drug is etripamil, which is designed to treat a tricky, hard-to-track disease called paroxysmal supraventricular tachycardia, or PSVT.

PSVT is an erratic arrhythmia; a racing heart beat that can be misdiagnosed as a panic attack.

“It feels like you’re having a heart attack,” says the CEO, “then goes away” — often by the time you get to the ER, leaving a mystified group of doctors and nurses puzzling it out.

Oliveto, though, estimates that about 1.5 to 2 million people have it in the US, though he freely admits that is a rough ballpark figure. Hospital records can only tell you so much about this.

Currently, one of the ways that this condition is treated is through catheter ablation, where you use heat or cold to kill heart tissue. IV adenosine is used in the hospital. At Milestone, they’re working on a spray formulation of a short-acting calcium channel blocker that can be administered at home through a rescue device, much the way asthmatics control a sudden attack.

Oliveto and the 10-member crew at Milestone took four doses into a Phase II study and came away with some dose-dependent responses on the top three.

Based on his talks with the FDA, Milestone reckons it can limit the Phase III efficacy study to about 300 patients, planning to get started late this year or early next and wrap it around mid-2019. At that point the company will need to look for more cash if it wants to go solo into the separate safety study that the FDA will require for a cardio therapy like this.

Small team, single asset biotech working in the daunting field of heart therapies sounds like a profile for a buyout, if the cards fall the right way. Oliveto, who headed Chelsea Therapeutics when the company was sold to Lundbeck in a $658 million deal, knows a bit about that topic. But he’s keeping his options open, thinking about new venture cash or an IPO or … a sale.

Time will tell. In the meantime, he also plans to start laying the groundwork for marketing.

Following Novo Holdings’ lead is Forbion Capital Partners and funds managed by Tekla Capital Management, with participation from Milestone’s existing investors: Domain Associates, Fonds de solidarité FTQ, BDC Capital, Pappas Capital, and GO Capital.


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RAPS Regulatory Convergence 2017