Realm Therapeutics has scrapped development of PR013 after the opthalmic drops failed to improve outcomes in patients with allergic conjunctivitis. The setback wiped almost 30% off Realm’s stock as investors digested the loss of the program and assessed its implications for the rest of the pipeline.
Investigators enrolled 90 patients in the trial and randomized them to receive one of two doses of PR013—a topical ophthalmic solution of hypochlorous acid—or placebo.
Realm hoped to link PR013 to reductions in ocular itching and conjunctival redness. But in a brief statement to discuss its findings, the Malvern, Pa.-based company said the drug “did not demonstrate efficacy.” Realm responded by halting further development of PR013 and switching its attention to PR022 and RLM023.
Atopic dermatitis drug PR022 is the more advanced of the two candidates. The prospect is a topical gel formulation of hypochlorous acid, the same active ingredient used in the failed PR013 program. Realm sought to downplay the readthrough from the PR013 failure to PR022 by noting differences in the immunological pathways underlying atopic dermatitis and allergic conjunctivitis.
Data from a phase 2 trial of PR022 in patients with mild-to-moderate atopic dermatitis are due in the third quarter. The 120-person clinical trial is targeting the same indication as the drug at the center of Pfizer’s $5.2 billion takeover of Anacor Pharmaceuticals, but expectations are currently moderate. Realm’s market cap stands at around $62 million following the failure of PR013.
If PR022 goes the same way as PR013, Realm would be left with RLM023—also known as PR023—to fall back on. Realm plans to file an IND to trial RLM023 in patients with acne in the fourth quarter. A portion of the $26 million Realm raised last year is earmarked for taking the drug through a phase 2 proof-of-concept trial.
As with PR022, Realm thinks the prospects of RLM023 are unaffected by the failure of its eye drug.
“Atopic dermatitis and acne vulgaris have different immunologic pathologies and are otherwise unrelated to allergic conjunctivitis,” Realm CEO Alex Martin said in a statement. “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.”