Realm Therapeutics Flunks PhII Trial for Conjunctivitis Drug

Realm Therapeutics, Inc., based in Malvern, Pennsylvania, announced today that its PR013, failed to show efficacy in its Phase II trial for allergic conjunctivitis. As a result, shares in the company dropped 34 percent. The company indicates it is halting further development of the program.

PR013 is a proprietary, topical ophthalmic solution that contains high concentrations of hypochlorous acid.

"While the PR013 results are disappointing, we are extremely pleased with the progress we are making with our dermatology programs, as they continue to be our top priority," said Alex Martin, Realm’s chief executive officer, in a statement. "Atopic Dermatitis and Acne Vulgaris have different immunologic pathologies and are otherwise unrelated to Allergic Conjunctivitis. We remain confident in our technology’s potential to deliver immunomodulatory and anti-inflammatory benefits, and continue to believe that it has potential for application in multiple disease areas."

The company continues to enroll patients for its Phase II trial of PR022, a topical gel, in a Phase II trial and expects top-line results in the third quarter of this year. Realm also says that its preclinical program in Acne Vulgaris is advancing. It has held preliminary talks with the U.S. Food and Drug Administration (FDA) and plans to file an Investigational New Drug (IND) application for RLM023 in the fourth quarter of this year for RLM-023 in Acne Vulgaris.

On February 27, Realm announced that the U.S. Patent and Trademark Office (USPTO) had issued allowances for two new patents that expanded its intellectual property portfolio. The first was for U.S. Patent Application No. 15/170,046, "Methods for Treating Inflammation Associated with Allergic Reaction," which relates to its two lead candidates, PR013 and PR022. The patent provides coverage through March 2032.

The second is U.S. Patent Application No. 14/670,046, "Methods and Compositions for Treating Inflammatory Disorders." This is related to the inflammation associated with Type II or Type III hypersensitivity reactions, and grants the company extra exclusivity for its immunomodulatory technology for auto-immune disorders.

"These patent allowances expand the breadth of our intellectual property estate and further validate the proprietary nature of our immunomodulatory technology," Martin said in a statement. "As we look forward to the result of our Phase II study for PR013 in Allergic Conjunctivitis later in the first quarter, as well as the results of our Phase II trial for PR022 in Atopic Dermatitis in the third quarter, we are gratified to have even stronger patent protection for our dermatology and ophthalmology programs. We believe our proprietary technology has potential applications across a wide array of indications and are pleased that our patent portfolio extends to the treatment of autoimmune disorders."

The company’s PR022 for atopic dermatitis, if successful, would face competition from Pfizer Inc.’s Eucrisa (crisaborole). Pfizer picked up the drug in 2016 when it acquired Anacor Pharmaceuticals, Inc. for $5.2 billion. EvaluatePharma projected Eucrisa sales in 2022 at $1.3 billion, but at least some of that is because of its first-to-market advantage. And there are other drugs that are PDE-4 blockers in development,including drugs by Otsuka and Mitsubishi Tanabi, and other treatments in development by GlaxoSmithKline and Novartis AG, as well as Sanofi US and Regeneron Pharmaceuticals, Inc.’s Dupixent.

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