The Company’s fibrosis program focuses on non-alcoholic steato-hepatitis (NASH), and also includes idiopathic pulmonary fibrosis, scleroderma, congestive heart failure, and liver cirrhosis.
Our technologies offer a quantitative method for measuring changes in tissue collagen synthesis and breakdown.
Our technology has the potential to measure liver collagen synthesis rate and liver collagen degradation/turnover rate from blood samples. These turnover measurements can be used as early predictors of fibrosis resolution in response to treatment with a therapeutic. Our tests can show if there is a reversal of cirrhosis, reduction of fibrosis, and an improvement of non-alcoholic steatohepatitis (NASH) activity. KineMed’s non-invasive blood-based biomarkers for liver disease provide information on a drug candidate’s effect on fibrosis progression without the need for hospital-based biopsies.
While collagen is popularly known for its essential role in maintaining tissue strength and healing, including its role in youthful looking skin, the overabundant production of collagen due to injury or disease (termed fibrogenesis) can lead to a deadly disease known as fibrosis. Diseases involving fibrosis cause nearly 45% of all deaths in industrialized nations, according to statistics published in the Journal of Pathology (J. Pathol. 214, 199-210, 2008).
Fibrosis is often the end result of chronic inflammatory reactions induced by a variety of stimuli including persistent infections, autoimmune reactions, allergic responses, chemical insults, radiation, and tissue injury. Although current treatments for fibrotic diseases such as idiopathic pulmonary fibrosis, liver cirrhosis, systemic sclerosis, progressive kidney disease, and cardiovascular fibrosis typically target the inflammatory response, there is accumulating evidence that the mechanisms driving fibrogenesis are distinct from those regulating inflammation. Studies now suggest that ongoing inflammation is needed to reverse established and progressive fibrosis.
No therapeutic is currently approved by the US Food and Drug Administration (FDA) for the treatment of fibrosis. The difficulty of tackling the mechanism of fibrosis-based disease is illustrated by recent trials of drugs to treat Idiopathic Pulmonary Fibrosis (IPF), a common and lethal lung disease, affecting approximately 200,000 Americans. Thus far, trials have failed to yield drugs that improve patient outcome.
KineMed’s patented approach to monitoring fibrosis uses proprietary stable isotope labeling techniques combined with ultra-high resolution mass spectrometry to measure the dynamics of collagen in the body. This technology provides unique insights into the causal events underlying fibrotic diseases. This program is currently accelerating the development of therapeutic approaches to fibrosis in collaboration with academic, government and commercial partners. The Small Business Innovation Research Program (SBIR) administered by the National Science Foundation, has awarded KineMed a phase II grant to fund the development of KineMed’s lead compound, Noscapine, an inhibitor of fibrogenesis.
“Before you can attempt to modulate fibrosis, you have to be able to measure it. Our approach has already proven useful for a broad range of diseases.
The ability to translate these techniques from preclinical studies into humans makes this a particularly powerful approach. Any company seeking to develop drugs that reduce abnormal collagen production can benefit from KineMed’s expertise and remarkably sensitive analytic tools.”
Marc Hellerstein, M.D., Ph.D.
Co-Founder and Chairman of the Scientific and Clinical Advisory Boards