Data from a recent trial of EVO301, a long-acting injectable interleukin-18 binding protein, show that the anti-IL-18 protein was effective for the treatment of moderate-to-severe atopic dermatitis (AD) in adults.
Elevated IL-18 levels have long been associated with inflammatory and autoimmune diseases, and this small but meaningful trial demonstrated safety and efficacy levels that may make EVO301 a promising option for future AD therapies.
Key takeaways:
- EVO301, an investigational biologic, was effective for the treatment of moderate-to-severe AD in adults.
- The drug was well tolerated and did not lead to any treatment discontinuations.
Surprise Results
According to topline phase 2a results, EVO301 rapidly improved moderate-to-severe AD in adults, providing highly statistically significant outcomes. Mark Lebwohl, MD, dean for clinical therapeutics, professor and chairman emeritus of the Department of Dermatology at the Icahn School of Medicine at Mount Sinai, expressed optimism about the findings.
“The results with this anti-IL-18 are very promising,” he said. “These are phase 2 data with a small number of participants, but the results that we are seeing are a complete surprise.”
The results came from a randomized, double-blind, placebo-controlled trial that evaluated the safety and efficacy of two 5-mg IV doses of EVO301 for the treatment of moderate-to-severe AD over 12 weeks. Seventy participants were included in the trial, 48 of whom received EVO301 and 22 of whom received placebo.
Participants in the EVO301 group received a dose on day one and again on day 28. The primary endpoint was the difference in percentage improvement from baseline in EASI scores between the active and placebo arms.
Results showed those treated with EVO301 experienced reductions in EASI scores of 41%, 50%, and 55% at weeks 4, 8 and 12, respectively. Participants receiving placebo saw EASI reductions of 18%, 16%, and 22%, during the same time periods.
Researchers also found that 23% of participants treated with EVO301 achieved an IGA score of 0 or 1 and a reduction of 2 points or more from baseline, compared with 0% of those who received placebo.
“This is as effective as any of the well-established drugs currently on the market,” Dr. Lebwohl said, adding that there is an urgent need for new options for the growing number of patients suffering from AD. “EVO301’s ability to target the novel IL-18 mechanism and show clinically relevant treatment activity, without side effects, could offer real benefit for patients in such a heterogeneous disease.”
Moving Forward
For the 16.5 million adults in the United States affected by AD, the condition not only causes physical discomfort, but it also affects quality of life, leading to sleep disturbances and emotional distress. Identifying effective management strategies and treatment options for AD, which is prevalent worldwide, remains an important objective for the global dermatologic community.
In addition to establishing its efficacy, the trial found that EVO301 was well tolerated. No related serious or severe adverse events were reported, and none of the participants discontinued treatment because of drug-related adverse events. The rate of adverse events was similar between the active and placebo arms.
Evommune, the clinical-stage biotechnology company developing EVO301and other innovative therapies that target key drivers of chronic inflammatory diseases, plans to present full results from the phase 2a trial at upcoming medical conventions.
“This is a big milestone for Evommune,” said Luis Peña, the company’s president and CEO. “These data support our plans to move EVO301 into a Phase 2b dose-ranging trial where we can optimize the dose and seek to further improve patient outcomes.”
The company is also evaluating potential additional indications for EVO301, including ulcerative colitis.
“With multiple programs now having positive Phase 2 data,” added Peña, “we are poised to grow into a significant company in the immunology space.”
