AMPEL's System For Drug Repositioning Confirmed By Success Of Phase 2 Trial Of Stelara In Lupus

Janssen Announcement Validates AMPEL's Ranking of Stelara

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Oct 25, 2018, 16:21 ET

CHICAGO, Oct. 25, 2018 /PRNewswire/ -- AMPEL BioSolutions is excited to announce 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."

About Lupus
Lupus is a systemic autoimmune disease primarily affecting women of childbearing age. Despite advances in care, lupus is still associated with increased mortality and the frequency of progression to chronic renal failure has not improved. The immune system that normally protects against infectious diseases becomes misdirected and attacks the person's organs and tissues. Lupus is more severe in African-American and Hispanic women. Although a multitude of drugs with potential for lupus are tested for efficacy every year, in the last 60 years only one drug has been FDA-approved for lupus (Belimumab/Benlysta®).

About AMPEL BioSolutions

AMPEL is a technology company based in Charlottesville, Virginia focused on identifying, validating and testing effective drugs for autoimmune and inflammatory diseases. AMPEL's goal is the right drug for the right patient at the right time. AMPEL's five divisions (Bioinformatics/Machine Learning; Clinical Trial Design/Operation; Mobile eHealth; Education; Systems Immunology) work together to solve problems and overcome barriers that emerge while pursuing true precision medicine for patients with lupus and gout.

About Janssen and Stelara®

Janssen is headquartered in Titusville, New Jersey and is a pharmaceutical company of Johnson & Johnson. Janssen is committed to providing safe and effective medicines as well as the services and support that contribute to healthy outcomes. Janssen is committed to the best science, the most creative minds and an openness to collaborate with researchers, governments and patient organizations at every stage. The FDA approved Stelara® for severe plaque psoriasis in 2009, psoriatic arthritis in 2013 and Crohn's disease in 2016. Stelara® is a modern, smart-bullet biologic drug specific for an inflammatory mediator in the immune system called IL12/23.

SOURCE AMPEL BioSolutions