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Dermira Ends Acne Program After Phase III Failure, Tries To Keep Focus On Hyperhidrosis Drug

 
• By Mandy Jackson

FDA approval for DRM04 in hyperhidrosis is expected at the end of June, but Phase III data for DRM01 in acne was the main event for investors. CEO Tom Wiggans said Dermira will try to understand what went wrong, while staying focused on DRM04 commercialization and lebrikizumab in Phase IIb.

Acne on face

Dermira Inc. Chairman and CEO Tom Wiggans did not pull any punches when talking about negative Phase III results for acne candidate olumacostat glaseratil (DRM01) March 5, instead being very upfront that the CLAREOS-1 and CLAREOS-2 studies failed and did not merit continued development of the drug.

Wiggans told Scrip that while Dermira was "stunned" by the results – the most anticipated milestone for the company's investors this year – the data will not throw the company into crisis mode

Hyperhidrosis Potential

Hyperhidrosis, otherwise known as excessive sweating, is a 15m-patient market in the US, including 10m people with axillary (underarm) hyperhidrosis. The main treatments are aluminum salts or injections with Allergan PLC's Botox (onabotulinumtoxinA) every three months. Also see "No Sweat – Hyperhidrosis Patients Seek Broader Approvals; Botox Access An Issue" - Pink Sheet, 16 November, 2017.

Dermira's glycopyrronium tosylate (DRM04) is a once-daily topical treatment that is designed to inhibit the interaction between acetylcholine and the cholinergic receptors responsible for sweat gland activation or sweat production.

"Trials have shown that if you use it a few days, it has a rapid effect," CEO Tom Wiggans said in an interview during the American Academy of Dermatology (AAD) meeting Feb. 16 to 20 in San Diego.

While axillary hyperhidrosis is the first indication for which the company is seeking approval, Dermira may also pursue development in palmar hyperhidrosis, or excessive sweating of the hands

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