AMPEL BioSolutions announced proof-of-principle for a multi-pronged approach to rank small molecules and biologics for safe, effective treatment of patients with Systemic Lupus Erythematosus (SLE) and reduce the risk of trial failure that has plagued the lupus community for years. AMPEL’s approach combines an evidence-based CoLT® scoring system with validation of the pathway inhibited by a drug identified as high-priority utilizing LuGENE™, a Big Data, Machine Learning methodology. The announcement was made today at the American College of Rheumatology Annual Meeting.
Today’s announcement by Janssen of the efficacy of Ustekinumab/Stelara® in their year-long worldwide Phase 2 lupus trial validates AMPEL’s ranking of Stelara® as a top priority candidate for repositioning into SLE. AMPEL’s approach is a powerful tool for the Pharma/Biotech community to assist in prioritizing pipeline assets for application into lupus clinical trials.
The need for new drugs for lupus patients is urgent, as only one drug has been approved for lupus in the last sixty years, Belimumab/Benlysta®. Stelara® is a promising candidate that Janssen is pursuing into Phase 3 trials. The results Janssen announced this week at the annual ACR meeting of physician-scientists specializing in rheumatic and autoimmune diseases indicate that Stelara® has an excellent lupus safety profile and significantly reduces lupus disease activity compared to placebo control.
In addition, Stelara® reduces the severity of skin involvement in lupus patients. Moreover, Big Data bioinformatic results demonstrate that the way that Stelara® normalizes lupus disease activity is different from Benlysta® and type I interferon-blocking drugs, thus paving the way for future combination therapies that may be synergistic with each other to bring relief to lupus patients.
“AMPEL’s technique of literature mining and bioinformatics to de-risk repositioning of existing FDA-approved drugs into lupus is evidence-based and emerges from one of the largest worldwide databases of over 3000 microarray and RNASeq gene expression profiles collected from the periphery and tissue biopsies of lupus patients as well as normal individuals,” says AMPEL co-founder and CMO Dr. Peter Lipsky. “AMPEL’s CoLT® scoring system utilizes information from pre-clinical models, in vitro data and clinical studies of autoimmune diseases similar to lupus to assess suitability of a drug for testing in lupus patients.”
Source – PR Newswire