Trevena Inc (NASDAQ:TRVN) just kicked off a two concurrent phase III pivotals in its lead pain management candidate, Oliceridine. The trials are set to wrap up come the turn of he year, and topline should hit press at some point during the first quarter of 2017. This short term timeframe means we could see an NDA accepted for review during Q2 2017, and at a push, a regulatory approval before the end of next year. This makes Trevena a potentially rewarding short term exposure – assuming, of course, the candidate in question can hold its own in the ongoing phase IIIs. With this in mind, and as things get rolling, here’s a look at what’s under investigation, and what an approval might mean for Trevena and its shareholders.
Let’s look at the science first. Oliceridine is an intravenous opioid drug, designed to improve upon the currently available standard of care options in the space. To understand how, a basic knowledge of how the current options work is necessary. Conventional opioids (that is, at least, those that target the μ‑opioid receptor; read: the vast majority) work by acting on two specific pathways – one called the G protein pathway and the other called the B-arrestin pathway. The first is the pathway associated with the analgesic effects of opioid treatment. The second is associated with what is called the ORAE risk of this kind of treatment – essentially, the undesirable effects that come about when a patient undertakes a chronic administration of an opioid based compound, morphine‑induced constipation, respiratory depression, and analgesic tolerance.
Oliceridine is designed to have the same analgesic effect as the conventionally available treatments (by acting upon the G Protein pathway) but avoid the ORAE risks, by not acting upon the B-arrestin pathway. That’s the theory.
There have been 4 primary clinical trials to date. A phase I and a phase Ib in healthy volunteers to assess tolerability and dosing, a phase II in postoperative pain following bunionectomy surgery (surgery to remove bunions) and a phase IIb in postoperative abdominoplasty pain (tummy tuck, colloquially). Safety and tolerability looked fine in the two phase Is, so there’s not much to discuss there. In the phase IIs, where things got a little more interesting, efficacy also looked good. The first phase II demonstrated a stat sig improvement in analgesic activity compared to placebo. Even better, the second phase II showed a stat sig improvement in analgesic activity over morphine treatment. No serious AEs were reported, and the mild AEs were primarily drug related and no more serious than the control morphine arm. Even more importantly, the ORAE risk associated AEs came in reduced for the Oliceridine arm when compared to the morphine arm. This is where things stand heading into the ongoing and above mentioned pivotals. For reference, the first of the two pivotals, called APOLLO-1, is targeting postoperative bunionectomy pain and the second, called APOLLO-2, is targeting postoperative abdominoplasty pain. Both involve three arms – a placebo arm, a morphine arm and an Oliceridine arm, the latter of which is broken into three further subsections, each of which involves a different dosing regimen.
So what sort of a market could Trevena Inc (NASDAQ:TRVN) be targeting with the drug if the phase IIIs come out as hoped? Well pain management is a huge global market, worth a little over $50 billion at present. Opioids account for circa $11 billion of this, and this figure should grow to $21 billion by 2020. Intravenous opioids are the go to method for any inpatient delivery, and as such, represent a low double digit billion-dollar market right now.
So what are we looking at going forward? Well, chances are we will see some level of interim release, primarily because the test period is so short. Patients in both trials will be monitored across the 48-hour period immediately after their respective operations, and so Trevena Inc (NASDAQ:TRVN) should have some reportable figures at a pretty regular interval across the next six to eight months. Any hint at efficacy (and anything that supports tolerability) during this period is a potential upside catalyst. As mentioned, topline is set for the first quarter of 2017, and this, alongside the NDA submission and subsequent FDA review, represent the major catalyst to watch.
At time of writing, the market has Trevena at a $376 million market capitalization.
Note: This article is written by Mark Collins and originally published at Market Exclusive.