The Californian biotech Dermira ($DERM) says its experimental sweat drug DRM04 passed one Phase III test but narrowly missed its target on a second late-stage trial--although analysts believe this will still be good enough to reap an FDA approval.
The company has released topline results from its Phase III Atmos-1 and Atmos-2 pivotal trials for DRM04--a topical anticholinergic product candidate in development for patients with primary axillary hyperhidrosis (aka excessive underarm sweating).
The data showed that in the Atmos-2 trial, the once-daily topical treatment DRM04 produced statistically significant improvements for both co-primary endpoints and both secondary endpoints compared to vehicle.
The co-primaries were measured over 4 weeks and assessed the proportion of patients who achieved at least a four-point improvement from baseline in sweating severity as measured by the Axillary Sweating Daily Diary (ASDD)--Dermira’s own patient report card--and the average absolute change from baseline in gravimetrically-measured sweat production.
The secondary endpoints in both trials measured the proportion of patients who had at least a two-grade improvement from baseline as measured by the Hyperhidrosis Disease Severity Scale (HDSS) and the proportion of patients with at least a 50% reduction from baseline in gravimetrically-measured sweat production.
But in the Atmos-1 trial, the drug narrowly missing statistical significance on the average gravimetric measure of sweat production. After playing with the numbers, however, Dermira spun this into a more positive outcome, as it excluded an analysis center (something it was permitted to do) with “extreme outlier data”, which made the drug’s outcomes look a little better in Atmos-1.
Analysts at Leerink however were happy with the data, with Seamus Fernandez saying in a note to clients that the firm was “raising our overall probability-of-success from 75% to 85%, and increasing our price target from $46/shr to $47/shr.”
In a breakdown, the company believed that the totality of DRM04's data suggests approval is likely and the “highly credible, pre-specified statistical analysis plan and a deeply experienced management team further increases our conviction in approval.”
Fernandez explained: “The simplest conclusion we draw from the overall DRM04 results is that the data are highly consistent and meaningfully positive across all of the primary and secondary patient reported outcomes (ASDD & HDSS), as well as the secondary outcome of the percentage of patients achieving a 50% reduction in gravimetric sweat measures from baseline.”
One of the more recent drugs to be approved for this condition is Allergan’s ($AGN) injectable Botox, which has a license in severe primary axillary hyperhidrosis--but only after topical treatments have failed.
Fernandez said: “Notably, the Botox label is based purely on the successful secondary endpoints in Atmos-1 & 2. However, that doesn't fully exonerate the one pre-specified co-primary endpoint that did not achieve a statistically significant result.
“But given the fact that one analysis center in the ATMOS-1 study, as identified by the pre-specified statistical analysis plan, had a "cluster of patients that had very extreme gravimetric measurements, 15 standard deviations from the mean," we believe the exclusion of these patients is highly credible and should pass muster with FDA.”
Based on the results of these trials, Dermira said it plans to submit an NDA to the FDA for the approval of DRM04 for the second half of 2017--subject to it completing the Phase III ARIDO trial, an open-label trial assessing the long-term safety of DRM04.
The company was up 4.7% pre-market.