- Realm Therapeutics, a small clinical-stage biotech company, announced Tuesday morning that its lead drug candidate failed in a Phase 2 eczema study.
- While the company didn't provide specific data on the trial in a statement, it clearly stated the topical gel formulation, PR022, failed to achieve the primary endpoint of working better than a vehicle in improving the Eczema Area Severity Index.
- In light of the results, Realm said it will review its two other pipeline programs, PR022 for psoriasis and RLM023 for acne, both of which are preclinical. The Malvern, Pennsylvania-based company plans to provide an update next month on the programs.
This is the second Phase 2 failure this year for Realm. In March, it announced a topical ophthalmic solution failed its clinical trial for allergic conjunctivitis. Now, another of its drug candidates has fallen short for atopic dermatitis, a serious form of eczema.
Investors hit the stock then, and slammed it harder after this news on the London Stock Exchange's Alternative Investment Market. Shares fell 50% Tuesday.
Realm CEO Alex Martin said in a statement the company is "conducting a full review to determine whether there is a path forward" in eczema, "and to evaluate the implications" for the its acne and psoriasis programs.
These three programs make up the company's entire drug pipeline.
Realm also divulged its most recent financial picture Tuesday in its second quarter earnings report. Cash and cash equivalents were at $23.7 million at the end of June, down from $33.9 million at the beginning of the year.
The path forward is murky at best, as it is for any small biotech that suffers failure in clinical studies. Realm's pipeline is small and shrunk as 2018 progressed. The company is now a self-described clinical-stage company with no ongoing clinical trials.
Realm's sole source of revenue comes from a licensing deal for a medical device used for cleansing and debriding acute and chronic wounds, which gives them a yearly minimum of $900,000 in royalty payments through March 2021.
The company said it expects to provide an update on the future of its two remaining preclinical programs in September.