Positive Clinical Trial News: Janssen, Humanigen, Pfizer, Equillium and ChemoCentryx
There was a handful of positive clinical trial news reported today. Here’s a look.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced two Phase III trials, DISCOVER-1 and 2 demonstrated Tremfya (guselkumab) improved fatigue in adults with active psoriatic arthritis (PsA). It also maintained that effect through 52 weeks of active treatment. Fatigue is classified as one of the three most important symptoms in patients with active PsA, with moderate to severe fatigue reported in up to half of these patients.
“Data from the DISCOVER-1 and DISCOVER-2 studies demonstrating Tremfya reduced fatigue through 52 weeks provide evidence of an additional treatment benefit for patients with active PsA,” said Alyssa Johnsen, vice president, Rheumatology Disease Area Leader, Janssen Research & Development. “The positive outcomes in fatigue assessment add to the body of data for Tremfya, which has shown improvements in multiple clinical outcomes including joint symptoms, skin symptoms, soft tissue inflammation, and physical function.”
Humanigen announced positive interim Phase III data of lenzilumab in hospitalized COVID-19 patients. They found the drug had a clinically meaningful impact on patient recovery. About 37% more recoveries were seen in the lenzilumab arm of the trial compared to standard-of-care (SOC). As a result, the company plans to increase enrollment to about 515 patients, which would increase the likelihood of hitting the primary endpoint while maintaining the power of the trial at 90%.
“Based on this feedback from the DSMB, we believe the Phase III trial is significantly de-risked,” said Dale Chappel, Humanigen’s chief scientific officer. “Targeting 402 events improves the probability of success, maintains the power of the study at 90%, and further supports our plans for Emergency Use Authorization (EUA) and Biologics License Application (BLA) submission. We are working to quickly activate additional trial sites across the U.S. to support rapid enrollment and increase access to lenzilumab with a continued commitment to inclusion and diversity.”
Pfizer reported positive data from its Phase III trial of Xeljanz (tofacitinib) in adults with active ankylosing spondylitis (AS). The drug is not currently approved by the U.S. Food and Drug Administration (FDA) for AS. The trial met its primary and key secondary endpoints of Assessment in SpondyloArthritis International Society (ASQS) 20 and 40 response, respectively, compared to placebo at 16 weeks.
“Ankylosing spondylitis is a debilitating condition, and its often-progressive nature affects patients for most of their adult lives, limiting physical function and perceived health-related quality of life,” said Michael Corbo, Pfizer Global Product Development’s chief development officer, Inflammation & Immunology.
Equillium announced positive interim data from the third cohort of the Phase I EQUATE trial of itolizumab in the first-line treatment of acute graft-versus-host disease (aGVHD). The overall response rate across the first three dose cohorts was 80%, with seven of eight patients hitting a complete response and one a very good partial response by Day 29.
“We continue to accrue compelling data in the EQUATE trial — the rapid and durable response rates in patients treated with itolizumab meaningfully exceeds what has been observed in patients with severe aGVHD treated with steroids alone,” said Bruce Steel, Equillium’s chief executive officer. “We plan to engage the U.S. Food and Drug Administration (FDA) to explore expedited regulatory pathways to advance itolizumab for the first-line treatment of aGVHD.”
ChemoCentryx presented data on the ADVOCATE Phase III trial of avacopan for ANCA-associated vasculitis at the ACR Convergence 2020 virtual annual meeting of the American College of Rheumatology. The study demonstrated that avacopan was as effective as prednisone in moving patients into remission by 26 weeks and was superior to prednisone for sustained remission after 52 weeks. The presentation was made by Peter Merkel, from the Hospital of the University of Pennsylvania.