New York, NY – (GLOBE NEWSWIRE) – October 13, 2016 – Filament BioSolutions Inc., a company focused on the development and commercialization of innovative clinical nutrition products announced today an exclusive license to a portfolio of intellectual property covering FB-4040, a patented formula for the nutritional management and prevention of kidney stones and other indications. The license was completed with several academic institutions led by New York University (NYU), and included both Massachusetts General Hospital in Boston and University of California, San Francisco (UCSF).
FB-4040 is a patented formula of generally-recognized-as-safe (GRAS) citrates and anti-oxalates that alters urine chemistry to decrease the risk of kidney stone formation. The formula was invented by a team of thought leaders in the science and clinical management of patients suffering from kidney stones, including David S. Goldfarb M.D., Clinical Chief of Nephrology at NYU Langone Medical Center, Marshall Stoller, M.D., Professor and Vice Chair of Urology at UCSF, and Brian Eisner, M.D., Co-Director of the Kidney Stone Program at Massachusetts General Hospital and Assistant Professor of Surgery at Harvard Medical School. The inventors of FB-4040 will also join Filament’s scientific advisory board to support the development and launch of the product.
FB-4040 represents the second product candidate in Filament’s portfolio. Filament is leveraging its industry-leading clinical, product and commercial development platform to generate robust, clinical evidence to maximize the value of each product. In addition to engaging scientific leaders, Filament has partnered with leaders in the formulation and flavoring industry to enhance patient experience with its products. Filament is currently undertaking pre-commercialization activities to enable rapid and seamless market access to its portfolio of therapeutic nutrition products once efficacy is demonstrated in clinical trials.
Tom Cirrito, CEO of Filament, remarked, “The license to FB-4040 exemplifies Filament’s core model of identifying products supported by a solid scientific rationale that will provide significant clinical benefit. We are also privileged to continue working with the inventors, as they will provide invaluable scientific and clinical insight to us as we aggressively pursue the initiation of our clinical studies. Adding this product to our portfolio strengthens Filament’s goal to become the premier evidence-based clinical nutrition company in the industry with an unwavering commitment to the highest level of scientific rigor.”
Dr. Goldfarb said: “This technology, now called FB-4040, is an effort to leverage established science to create a safe and convenient solution that achieves clinically-significant stone prevention. We believe that there is a substantial unmet need for a safe, daily-use product for patients. We are excited about Filament’s commitment to generate further clinical data on FB-4040 and look forward to supporting efforts to bring this product to the urology, nephrology, emergency medicine and primary care communities.”
Dr. Stoller added: “Patients at high risk for kidney stones always ask us how to prevent them. We set out to address that problem by applying our knowledge of urine chemistry and years of experience treating patients in our university-based kidney stone clinics, as well as the American Urological Association’s guidelines. Our hope is that further clinical trials will find this to be useful in preventing recurrent kidney stones.”
Dr. Eisner commented: “Recent research shows that less than 10% of patients with recurrent kidney stones are offered therapies for prevention. Our goal is to make kidney stone prevention widely available and most important, to improve the lives of patients and families.”
Kidney stones result when poorly soluble salts concentrated in urine precipitate and form hard deposits in the kidney. When stones obstruct the urinary tract, they cause extreme discomfort and pain. An estimated 17 million people in the US have a history of kidney stones, with 12% of American men and 7% of American women having at least one stone in their lifetimes. Approximately 50% of patients who experience a kidney stone will have a recurrence within 5 years. Kidney stone prevalence has been steadily increasing over the last few decades due to multiple risk factors including high rates of obesity and diabetes, rising global temperatures, and changes in dietary habits. Current management and prevention of kidney stones is primarily focused on dietary and lifestyle changes, and less frequently, prescription medications.
Filament BioSolutions, Inc. is a company focused on the development and commercialization of innovative clinical nutrition products. Filament is committed to the principle of evidenced-based nutrition, and is developing high-quality products that will undergo rigorous clinical trials with thought leader support. Filament is generating a portfolio of therapeutic nutrition products that are clinically proven to improve patient health. For more information about Filament BioSolutions, Inc., visit www.filamentbiosolutions.com.