Realm tanks again as second drug fails phase 2

Realm Therapeutics has reported its second midphase flop of the year. The setback threatens to wipe out Realm’s clinical-phase pipeline, leaving the immunology player with just a preclinical acne asset that features the same active ingredient as the failed programs.

Pennsylvania-based Realm’s latest woes stem from a phase 2 trial of PR022 in atopic dermatitis. The candidate features the same active ingredient—hypochlorous acid—as the Realm asset that failed a midphase allergic conjunctivitis trial in March. At that time, Realm tried to downplay to implications of the flop for PR022 by pointing to differences in the immunological pathways that underpin atopic dermatitis and allergic conjunctivitis. 

Regardless of those differences, Realm emerged from the PR022 trial with similarly weak data. Realm is yet to provide a look at the data but disclosed PR022 failed to outperform placebo on the Eczema Area Severity Index, causing the study to miss its primary endpoint. 

Realm responded to the previous phase 2 allergic conjunctivitis failure by dropping the trialed drug, PR013, and pinning its hopes on PR022 and the preclinical asset RLM023. The PR022 failure is yet to trigger a decision on the future of the asset but could ultimately have farther-reaching effects than the previous setback.

"Having just received the data, we are working to better understand this outcome and to analyze all of the data collected in the study," Realm CEO Alex Martin said in a statement. "We are conducting a full review to determine whether there is a path forward for our proprietary technology in atopic dermatitis, and to evaluate the implications for our acne and psoriasis programs." 

The psoriasis program is assessing PR022. The acne program is testing the aforementioned preclinical asset RLM023. Both programs are due to reach the IND stage around the turn of the year. Perhaps more importantly, PR022 and RLM023 are both formulations of hypochlorous acid, the ingredient that has now failed two midphase trials.

Realm thinks delivering high concentrations of hypochlorous acid downregulates multiple cytokines involved in inflammation. That encouraged Realm to create formulations of the ingredient tailored to a range of conditions. However, the back-to-back clinical failures have created doubts about the effectiveness of the approach. 

Shares in Realm fell more than 40% following news of the atopic dermatitis setback. The stock is down more than 50% on the high it hit in the run-up to the allergic conjunctivitis readout.  

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