Innocoll Holdings PLC (INNL) Could Pick Up Two US Approvals Before 2018

As the markets closed out on Friday, we got word that Innocoll Holdings PLC (NASDAQ:INNL) had completed enrollment in two phase III pivotals for its second lead development candidate, Cogenzia. The treatment, a diabetic foot infection target, is the second of two candidates that Innocoll is hoping to get approved before the close of the decade, with the first, Xaracoll, a post op pain target, set for NDA submission across the coming couple of quarters. Topline from the Cogenzia trials is slated for third or fourth quarter this year, so whatever happens, it’s going to be a big 24 months for the company and its shareholders. If things go well, Innocoll Holdings PLC (NASDAQ:INNL) could be looking at two approved products in both Europe and the US before the start of 2019. With this in mind, let’s take a look at the ongoing trials, and what to keep an eye on come topline when it hits.

So, Cogenzia. With a diabetic foot infection focus it’s not a particularly glamorous indication, but it’s a potentially lucrative one. Estimates put the global market for this indication at around $1.5 billion by 2017, with the US market accounting for more than 85% of this figure. Current treatment options are limited, and amputation is a highly prevalent resolution, so there’s a major unmet need. This means the company that brings an effective treatment to market should be able to pick up a decent sized penetration relatively quickly.

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The science behind this one isn’t all that complicated. When a diabetic patient gets a foot ulcer, there’s a high chance of it becoming infected. Current standard of care uses antibiotics to treat the infection, but there’s a high failure rate (up to 50%). The failure is rooted in the systemic administration of the antibiotics. They don’t target the infection with a high enough degree of localization toxicity, and this means they don’t completely eliminate the problem. Cogenzia is designed to work in combination with the current SOC antibiotics. It’s a topical administration formulation of antibiotic called gentamicin, which is already approved and generally considered safe for use in the US and Europe when administered systemically. At high doses, however, and specifically in the doses required to have an impact on a foot infection when administered systemically, it can be toxic. Innocoll Holdings PLC (NASDAQ:INNL)’s administration involves a sponge application, and so can be applied directly to the infection/wound. It’s essentially an antibiotic on a sponge, but one that could be easily worth a billion dollars with an FDA green light.

So what are we looking for from the data? Well, the primary endpoint is pretty simple – an improved rate of cure in patients that receive systemic antibiotics in conjunction with Cogenzia when compared to patients who just receive the systemic treatment. Initial assessment (and the data on which the primary endpoint meeting/not meeting will be based) will come after 10 days of treatment completion. After 90 days, a follow up investigation will measure efficacy and safety against various secondary endpoints.

The obvious thing to look out for from the data, therefore, is a higher cure rate in the active arm than the control arm, and a resulting meeting of the primary endpoint. Secondary endpoints, and specifically, tolerability, will also be key drivers behind the drug’s prospects come NDA submission. Looking at timelines, the short nature of the trial (the 10-day initial period plus the 90 days follow up) gives us plenty of things to watch. Chances are the company will offer up some degree of interim analysis based on the 10-day post treatment period, and this analysis will likely be an upside catalyst if it hints at efficacy in the active arm. That’s milestone one. Milestone two comes at topline release, slated for end of the third quarter, or early fourth quarter, this year. Beyond that, we’re looking at an NDA submission early 2017, assuming the data offers up some level of efficacy, and the agency’s accepting of this submission becomes a major upside catalyst when the time comes. Of course, the final point is PDUFA, which should come in sometime during the final quarter of 2017, if everything goes to plan.

One to watch going forward, with plenty of potential catalysts along the way.

Note: This article is written by Mark Collins and originally published at Market Exclusive.