Realm surrenders after back-to-back clinical defeats

Faced with a pair of phase 2 failures, Realm Therapeutics has abandoned the platform that underlies all its drug development programs and engaged advisers to look into a possible sale.

Realm has been focused on developing a series of products based on stabilized high-concentration hypochlorous acid, but with two midstage trials missing the mark in allergic conjunctivitis and atopic dermatitis, it has decided that going on with the program is futile. Its only remaining hypochlorous acid program was in acne and still in preclinical development.

Although there was a glimmer of efficacy at the high-dose end of the atopic dermatitis study, “we have decided to discontinue all of our drug development programs, which are all based on the company’s proprietary technology,” said Alex Martin, the Pennsylvania-based company’s CEO.

Realm has hired MTS Health Partners to help it look into options and has slashed its headcount, among other cost-cutting measures. At the end of June it had 15 full-time employees, according to an SEC filing dated mid-August.

Martin said Realm may also “look to in-license or acquire further assets or undertake a broader corporate transaction,” but isn’t giving any assurances that a deal will result.

Realm was hoping to show that high concentrations of hypochlorous acid could downregulate multiple cytokines involved in inflammation and so developed formulations of the active ingredient tailored to its target indications. Now, its left with no pipeline, around $21 million in ready cash, plus a modest royalty stream from a wound care product range.

It also has rights to an anti-itching product based on hypochlorous acid called Aurstat, which was approved several years ago as a medical device and had a similar formulation to Realm’s atopic dermatitis candidate PR022. Aurstat was taken off the market several years ago however, so the biotech could focus on the development of PR022 as a prescription drug.

Realm said it has no negotiations with interested parties on the go right now, and it remains to be seen whether there is anything among its remaining assets to entice a potential purchaser.