Dermira Inc (NASDAQ:DERM) just reported topline from its pivotal DRM04 trial. The trial investigated the efficacy of a condition called hyperhidrosis – a condition that affects more than 4 million individuals in the US. It’s essentially an over activity of sweat glands, and for many (circa 33% of the 4 million) is intolerable. This presents Dermira with a pretty healthy market if it can get DRM04 approved. The company is set to submit an NDA based on the phase III data, so here’s a look at what the results showed, and what an approval might mean for Dermira going forward.
So, the drug. DRM04 is a receptor inhibitor designed to stop the glands responsible for sweat production becoming active. When people sweat, the sympathetic nervous system passes a message to a group of receptors called cholinergic receptors (these are the ones responsible for sweat gland activation). It uses a molecule called acetylcholine to pass the message. When the acetylcholine reaches the cholinergic receptors, it binds to them, and they activate the glands that produce and release sweat. These types of drugs are called anticholinergics. Currently, the most common type of administration is oral dosage – that is, a patient takes a pill once or twice a day and the inhibitors go to work. There are a few issues with this type of administration, however. Specifically, the pharmacokinetics of oral administration can translate to certain levels of inefficiency. The nature of acetylcholine inhibition means that inefficiency (and the higher toxicity the inefficiency necessitates) can have some side effects. Dermira is trying to reduce the toxicity (and in turn, the side effects) by bringing a topical admisitration alternative to market. This topical administration is its DRM04 candidate. Patients apply the active compound to their skin at sweat regions (under the arms, groin etc.) and on absorption, the drug gets to work on the cholinergic receptor inhibition. Its topical qualities make it self administration, so patients need not book an outpatient appointment to pick up their treatment regimen.
So what did the data show?
The data comes from two trials – ATMOS 1 and ATMOS 2. Primary endpoints were a point measured improvement in sweating severity, with a four-point minimum improvement classed as an endpoint meet. In ATMOS 1, 52.8% of patients treated with DRM04 logged a min 4-point improvement, while only 28.3% of patients receiving vehicle therapy logged the gain. In ATMOS 2, these figures were 66.1% and 26.9 respectively.
Average reduction in sweat in ATMOS 1 was production was 104.9 mg in patients treated with DRM04 as compared to 91.9 mg in patients who received the vehicle, and in ATMOS 2 was 110.3 mg in patients treated with the drug as compared to 92.2 mg in vehicle patients. These data were backed up by a host of secondary endpoint meets, and safety and tolerability looks to be no issue aside from the usual topical issues – administration site irritability, redness etc. In other words, nothing to worry about.
So what are we looking at? Well, Dermira has said it plans to submit a new drug application (NDA) at some point during the second half of 2017. Why is it waiting this long? Well, there’s an ongoing trial called ARIDO, which is assessing the long term tolerability and safety of DRM04 as an extension to the above mentioned ATMOS trials. This needs to complete to sure up the data that will underpin the NDA, and in turn, boos the chances of approval. There’s also a meeting planned with the FDA to discuss the submission, and this will likely take place at some point during the first quarter of 2016.
The point here is that there is a bit of a wait before the company can submit its NDA, but this wait shouldn’t derail any potential opportunity come commercialization (if the company gets an agency green light). There aren’t any real contenders that could pose a threat to DRM04’s topical market penetration, so it’s just a case of waiting for the extension trial safety data and (so long as this data proves positive) waiting on the agency’s decision.
For final approval, we’re probably looking at sometime during the first half of 2018. A slow burner, but one to keep an eye on as things progress.