SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--iPierian, Inc., a biotechnology company developing novel therapies for neurodegenerative diseases, announced today the presentation of a preclinical study of their Tau antibody program that demonstrated the inhibition of global disease progression of Alzheimer’s disease across numerous endpoints and multiple brain regions. The promising in vivo efficacy results relate to iPierian’s lead antibody drug candidate, IPN007, which targets the Tau protein, and were described in an oral presentation at the Society for Neuroscience annual meeting in San Diego, CA. Based on this study, as well as additional in vitro and in vivo preclinical data and achievements in developing the IPN007 humanized antibody, iPierian plans to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in 2014.
“The results presented today are the latest in a series of findings suggesting that our lead antibody, IPN007, is a promising new therapeutic approach, targeting a novel form of secreted Tau, to slow the spread of Tau throughout the brain and, therefore, inhibit the associated disease progression,” said Nancy Stagliano, CEO of iPierian. “We will continue on our rapid development course with IPN007; our recently completed venture financing enables us to file an IND with the FDA next year in order to realize the potential of IPN007 for the treatment of Alzheimer’s disease and other tauopathies.”
Dr. Irene Griswold-Prenner, who leads iPierian’s Tau program, made the oral presentation at the Society for Neuroscience meeting of in vivo efficacy results in the P301L tauopathy mouse model.
- The study dosed the mice for six months using IPN002, the parental version of the lead candidate IPN007.
- The results demonstrated that IPN002 inhibited global disease progression across numerous endpoints and multiple brain regions—showing improvements in behavior, biochemistry and histopathology.
- IPN002 showed target engagement of Tau in the central nervous system (CNS), using the company’s proprietary assays that measure levels of free and bound Tau in the cerebrospinal fluid (CSF); these assays can be directly translated to human clinical trials.
- The target engagement results have also been replicated in two additional in vivo studies with IPN002 in the P301L transgenic mouse model.
In addition, iPierian described new data on a novel interaction between secreted Tau and amyloid beta that was confirmed in two in vivo studies in mouse models, following initial observations using the company’s induced pluripotent stem cell (iPSC) platform.
The Tau protein functions to stabilize microtubules and is abundant in neurons in the central nervous system. Aberrantly modified forms of Tau have been correlated with dementias such as Alzheimer’s disease (AD), frontotemporal dementia, progressive supranuclear palsy (PSP) and other tauopathies. Aberrant Tau accumulation correlates with the disease progression of dementia, in contrast to amyloid beta which maximally deposits years prior to dementia and, therefore, may be too late to intervene against. Animal models of AD have recently suggested that Tau can spread from one neuron to another, transmitting pathological Tau and correlating with the progression of AD pathology in humans. It is possible that therapeutics which slow the spread of Tau may also slow the clinical course of AD and related tauopathies.
iPierian is a biotechnology company developing novel therapies for neurodegenerative disease, specifically focused on discovering monoclonal antibodies against targets of the Tau protein for treatment of Alzheimer’s disease and other tauopathies (e.g., progressive supranuclear palsy, frontotemporal dementia). The company’s lead antibody, IPN007, represents a new approach to Alzheimer’s by targeting a novel form of secreted Tau protein that is differentially regulated in Alzheimer’s disease patients, to slow the spread of Tau throughout the brain and, therefore, inhibit the associated disease progression. iPierian’s monoclonal antibody program for Tau is based on novel Tau discoveries made using the company’s proprietary induced pluripotent stem cell (iPSC) technology. iPierian is located in South San Francisco, California. For more information, please visit www.ipierian.com.