AMPEL BioSolutions Announces Proof That A Novel Treatment Rapidly Eliminates Uric Acid Build Up in Gout Patients

CHARLOTTESVILLE, Va., Jan. 2, 2019 /PRNewswire/ -- AMPEL BioSolutions, a leading technology research firm based in Charlottesville, VA today announced the publication of new data in Arthritis Research and Therapy, co-authored by AMPEL Co-Founder Dr. Peter Lipsky, which demonstrates the effectiveness of Pegloticase (Horizon Pharma) in the resolution of urate depositions or tophi in people suffering from Gout. The full publication is here.

Gout is an ancient disease and the most common form of inflammatory arthritis in the US, with more than 8 million affected people. Gout is caused by the deposition of urate crystals into tissues. It is a genetically-based metabolic and inflammatory condition that can be worsened by diet, kidney disease and certain medications. Gout can cause inflammatory arthritis and is associated with many other diseases, including cardiovascular and kidney disease. The cardinal feature of Gout is the deposition of urate crystals into aggregates known as tophi, which can cause painful joint swelling.

Numerous treatments are available to decrease urate levels, but most are very slow acting and take years to resolve urate build up and cause visible clinical benefits. In contrast, Pegloticase has been proven to rapidly degrade urate levels, giving hope for a new thorough and proactive treatment for Gout patients. It is an innovative treatment that acts as a replacement therapy for the uricase enzyme that humans lost through evolution. Acting as the uricase enzyme, Pegloticase rapidly and persistently decreases urate levels inside the body and simultaneously resolves visible tophi and joint swelling that result from those urate deposits.

Dr. Brian Mandell, steering committee member of Gout Study Group, said, "Other than for acute attacks, it is no surprise that physicians have a no rush approach to the treatment of Gout. This has been reinforced over the years by the absence of any effective therapy to rapidly dissolve these tophi. Yet some patients are profoundly incapacitated by the presence of tophi not associated with flare ups, that cannot be seen by the naked eye, and that prevent the use of their hands, or drain through chronically infected sinus tracts. These patients, and those suffering from flare-ups, can benefit enormously from rapid tophi resolution. In the current reanalysis of data from the initial trials of Pegloticase, there is proof of concept that by maintaining an extremely low serum urate level over the course of only months, tophi can be very rapidly and in many patients completely dissolved.

By using its unique data mining capability, AMPEL was able to show that administration of Pegloticase caused complete resolution of all visible tophi in a mean of 9 months. This is dramatically faster than with other available urate lowering drugs that work by other mechanisms and may take years to resolve tophi. Since tophi are associated with local bone damage, loss of function when affecting the hand and also a decreased quality of life, rapid resolution of tophi provides new hope for the many people suffering from gout."

Dr. Peter Lipsky, Co-founder of AMPEL, said, "the results published today demonstrate and validate AMPEL's novel approach to data mining as a tool in understanding the effectiveness of a drug. In this case AMPEL's deep mining of data from the randomized controlled trials of Pegloticase, a U.S. approved treatment for chronic Gout, demonstrated that this treatment is proven to lower urate levels dramatically faster than the standard of care, given patients relief from both visible and lurking urate deposits."

About AMPEL BioSolutions

AMPEL BioSolutions is a technology research consultation firm specializing in translational and personalized medicine including drug and target identification, protocol design and management, biomarker identification, and bioinformatic analysis. AMPEL's approach is a powerful tool for the Pharma/Biotech community to assist in prioritizing pipeline assets for proof-of-concept Phase 2 clinical trials. AMPEL's bioinformatics pipeline utilizes BigData/Machine Learning techniques. 

Founded by Dr. Peter E. Lipsky and Dr. Amrie C. Grammer in 2013, the founders have over 20 years of collaborative experience in basic research, clinical research, and medicine as well as extensive experience in risk reduction in pharmaceutical development. Possessing a global understanding of the biomedical field as well as a commitment to precision, AMPEL is an intellectual resource for nonprofit organizations, pharmaceutical and biotech companies, and clinical research organizations in need of rapid and specific solutions to biomedical challenges.

About Gout Study Group

The Gout Study Group is a group of international experts on the science and clinical impact of gout who have decided to address the lack of sufficient discussion of this important condition by establishing a forum of communication centered on a new website.

The Gout Study Group website will host reports on the latest findings in the biology and clinical impact of gout, new insights into treatment and prevention as well as useful information on clinical management. While aimed primarily at researchers and health care providers, persons living with gout are welcome and will find a high-quality source of information provided by leading experts in the field. We believe that the entire gout community will benefit from a contemporary, reliable and interactive source of information on all aspects of this ancient disease.

SOURCE AMPEL BioSolutions

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