The J.P. Morgan healthcare conference is now in full swing in San Francisco and, as we outlined yesterday, we are already seeing a range of fresh inputs hit press related to the space.
While yesterday we focused on a buyout, and in particular, Celgene’s acquisition of Impact, today our focus is on to fresh data releases and their effect on the companies that took the stage in San Francisco to present them.
Specifically, we are focusing on Revance Therapeutics Inc (NASDAQ:RVNC) and Acorda Therapeutics Inc (NASDAQ:ACOR).
So, first up, Revance.
This data released is rooted in an asset called RT002, which the company was trialing as part of a phase II program designed to demonstrate safety and efficacy in a target indication of what’s called plantar fasciitis, which is a common debilitating form of foot pain.
RT002 is another name for DaxibotulinumtoxinA for Injection and the drug, from a mechanism of action (MOA) perspective, is a neuromodulator that’s designed as an entirely synthetic asset, meaning the technology eliminates the need for human- and animal-based components, which carry a potential risk of transmitting pathogens.
It is a long-lasting asset (designed to target pain for up to six months’ post administration) and, if approved, it would become the first drug of its type in a whole host of its initial target indications, including the above-mentioned plantar fasciitis, glabellar lines and cervical dystonia.
So, what did the data tell us?
Well, the data derived from a phase 2 a trial and the trial’s primary endpoint was defined as the reduction in the patient-reported visual analog scale (VAS) for pain at week 8 (so, 8 weeks after initial administration).
The trial was set up to compare active compounds to placebo and, as per the just reported data, patients who received the active compound reported a 54.2% reduction in VAS from baseline against the above-mentioned scale while patients in the placebo arm recorded a 42.6% reduction from baseline.
At a glance, these look like okay data but from a bottom-line perspective, the numbers mean that the trial failed to achieve statistical significance and, in turn, at this interim point, can’t be regarded as successful.
This is a 16-week trial so the data may improve as the study moves towards its completion point and, as relates to the recent data, management is blamed a stronger-than-expected placebo result on the failure to reach statistical significance.
Full data should hit later this quarter (or early second quarter) so we’ll keep an eye on things and update as appropriate when the updated numbers hit press.
At last night’s close, Revance was trading down by about 5% on the news and there’s a good chance we’ll see a continuation of this weakness, at least near term, as markets open for the US session on Tuesday.
Moving on, Acorda.
This one is in a similar vein to the above Revance data.
The data reported relates to an asset called SYN120, which the company has been trialing as a potential therapy in patients with Parkinson’s disease. Parkinson’s is a notoriously tough condition to treat and – as a result – it’s become one of the major areas of unmet need in the US healthcare system over the last twenty years or so.
The trial in question here is a phase 2 proof-of-concept study and, just as above, was set up to demonstrate a degree of clinical benefit in the target administration subsequent to administration.
And also as above, the numbers weren’t what the company hoped for.
The report that just hit press served up very little detail as far as specifics are concerned, with the company simply reporting that while several of the outcome measures trended in favor of drug versus placebo, neither the primary nor key secondary endpoints achieved statistical significance.
Obviously, then, that’s not a great result, and markets are interpreting it as such in their response to the development – Acorda is down around 6% as things stand.
This one’s got a second layer to it, however. The company is reportedly looking for a buyout and the latest data puts a real dent in its chances of a substantial premium on current share price if and when an entity makes a bid.
Again, then, there’s a real chance we’ll see further weakness as things mature to a close this week.