Dermira’s acne candidate DRM01 failed to hit the mark in two phase III trials and this has left the company with a big hole in its pipeline that could take years to plug.
The US biotech’s chief development officer Luis Peña said that DRM01 (olumacostat glasaretil) was unable to achieve a significant reduction in inflammatory and non-inflammatory lesion counts when compared to placebo in the CLAREOS-1 and CLAREOS-2 studies and “based on the information we have to date, we expect to discontinue the development programme”.
The fallout was particularly damaging for Dermira, which lost two-thirds of its share value yesterday after the news broke, because there had been high expectations of success in the trials. The company had already reported positive and consistent results in phase II studies, and several analyst reports were giving a high probability of success for the programme as recently as last week. It now thinks that a decision to cut the dose used in phase III on the strength of mid-stage dose-ranging data could potentially have scuppered the trials.
The topical drug, which acts to inhibit sebum production in the skin by blocking acetyl coenzyme-A carboxylase, had been expected to make inroads into the $3bn US market for acne products quickly as the first therapy with a new mechanism of action in decades. Analysts had suggested it could achieve sales of $250m-plus in a short time after launch.
The fact that Dermira is the third company to have a late-stage failure in acne after Novan and Foamix Pharmaceuticals both reported negative trial results in 2017 will be cold comfort.
The fall of DRM01 leaves Dermira with a late-stage candidate called glycopyrronium tosylate for hyperhidrosis or excessive sweating, which could claim FDA approval this year but is considered to offer a much smaller market opportunity than acne.
Also in its pipeline is an injectable drug for atopic dermatitis – IL-13 inhibitor lebrikizumab – which was developed by Roche and licensed to Dermira in a deal valued at up to $1.4bn last year. That programme is in mid-stage clinical testing.
Even if it successfully reaches the market, lebrikizumab will be playing catch-up with other drugs in atopic dermatitis, including Sanofi and Regeneron’s IL-4 and IL-13-targeting drug Dupixent (dupilumab), Pfizer’s new topical treatment Eucrisa (crisaborole) and potentially other drugs such as GlaxoSmithKline’s asthma drug Nucala (mepolizumab), which is in phase II for the skin condition.
Thankfully for Dermira, it is sitting on more than $550m in cash that will allow it to bring its other programmes forward and potentially add to its pipeline to fill the void left by DRM01.