ENDECE Neural Receives National MS Society Funding to Advance Myelin Repair Compound

Mequon, Wisc., Sept. 27, 2013 – ENDECE Neural today announced that it has entered into a sponsored research agreement for funding from the National Multiple Sclerosis Society through Fast Forward. Under the terms of the agreement ENDECE Neural will receive funding to advance the preclinical development of the company’s lead compound, NDC-1308. If successfully developed into a therapeutic, NDC-1308 could provide physicians with a treatment to restore and repair the protective covering surrounding axons (nerve fibers) in the brain and spinal cord.

ENDECE Neural will use the $225,000 in funding to validate preliminary data suggesting that NDC-1308 can restore and repair the axons’ protective covering, which is known as the myelin sheath. NDC-1308 demonstrated the ability to significantly remyelinate the myelin sheath in mice. The validation study will repeat the testing using an optimized formulation to determine how robustly NDC-1308 can stimulate remyelination in different regions of the mouse brain.

ENDECE Neural also announced today that researchers will present data from preclinical trials of NDC-1308 at the 29th Congress of the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark. The oral presentation, titled, “NDC-1308 induces remyelination in experimental models of multiple sclerosis,” is scheduled for Friday, Oct. 4 at 7:40 a.m. CDT during Parallel Session 12, “Looking into the Future: Experimental Studies of New Therapies.”

“Currently available therapies for MS are designed to slow the progression of the disease by reducing inflammation, but do not activate key target cells that can manufacture myelin,” said

Steven H. Nye, Ph.D., Vice-President of Discovery at ENDECE Neural and principal investigator in the study. “In our preliminary studies, a 2-week course of NDC-1308 led to a significant increase in the number of mature oligodendrocytes that produce and maintain the myelin sheath. With this National MS Society funding, we hope to validate and extend those results to help propel NDC-1308 into the clinic, a development that may ultimately improve the lives of patients with MS.”

“The National MS Society is committed to speeding solutions for people living with multiple sclerosis by pursuing promising paths and funding cutting-edge research,” noted Timothy Coetzee, Ph.D., Chief Research Officer, National MS Society. “We are pleased to partner with innovators like ENDECE Neural to enable continued development of their therapeutic programs.”

About NDC-1308

NDC-1308 is a novel chemical entity designed to address one of the root causes of MS by inducing differentiation of oligodendrocyte progenitor cells (OPCs) into mature oligodendrocytes (cells that synthesize and maintain the myelin sheath). By controlling key genes in pathways leading to myelin synthesis, NDC-1308 appears to stimulate restoration of the lost myelin sheath that is believed to cause the devastating symptoms of MS. NDC-1308 is a small molecule that readily crosses the blood-brain barrier, allowing it to reach the tissues in the brain and spinal cord where promoting myelin production is needed. ENDECE Neural discovered NDC-1308, and owns the intellectual property surrounding the compound. The company is developing NDC-1308 for potential use either alone or in combination with other MS therapeutics that slow the progression of the disease.

NDC-1308 is the most potent of several estradiol analogs (compounds resembling naturally occurring estrogen in structure and/or function) synthesized by ENDECE Neural that have the ability to directly induce differentiation of OPCs into mature oligodendrocytes. In a cuprizone mouse model of demyelination, a 2-week course of NDC-1308 (50 mg/Kg once daily) was associated with a 20% increase in remyelination of hippocampal regions of the brain (P<0.01).

“In addition to validating and extending the results from the cuprizone mouse studies, we hope the proof-of-concept study provides answers that will help us identify a viable formulation and dosing regimen for NDC-1308,” commented Dr. Nye.

“Our plan is to leverage that information for pharmacokinetic and safety studies that will form the basis for an investigational new drug (IND) application, ultimately guiding NDC-1308 to the clinic.”

About ENDECE Neural

ENDECE Neural is a private biotechnology company at the forefront of developing therapies to repair and potentially reverse damage caused by devastating neurological diseases such as MS. A wholly owned subsidiary of ENDECE LLC, ENDECE Neural was founded in 2011 to focus on the development of what could be the first drug capable of inducing remyelination of damaged nerves in patients with MS. The company is leveraging decades of accumulated knowledge about how activation of estrogen receptors in a specific manner affects gene regulation. Researchers at ENDECE Neural have identified small-molecule compounds that upregulate key genes in pathways involved in promoting myelin synthesis. ENDECE Neural is developing NDC-1308, which appears to directly induce OPCs to differentiate into mature oligodendrocytes that restore the depleted myelin sheath in patients with MS. ENDECE Neural discovered and owns the intellectual property surrounding its compounds, and the company’s management team has an extensive track record of successfully taking products from the laboratory through FDA approval and commercial release.

About Multiple Sclerosis

Multiple sclerosis, an unpredictable, often disabling disease of the central nervous system, interrupts the flow of information within the brain, and between the brain and body.

About the National Multiple Sclerosis Society and Fast Forward, LLC

The Society mobilizes people and resources to drive research for a cure and to address the challenges of everyone affected by MS. To fulfill this mission, the Society funds cutting-edge research, drives change through advocacy, facilitates professional education, collaborates with MS organizations around the world, and provides programs and services designed to help people with MS and their families move their lives forward. In 2012 alone, through its home office and 50-state network of chapters, the Society devoted $122.1 million to programs and services that assisted more than one million people. To move us closer to a world free of MS, the Society also invested $43.3 million to support more than 350 new and ongoing research projects around the world. The Society is dedicated to achieving a world free of MS. Join the movement at www.nationalMSsociety.org.

Fast Forward, LLC was established by the National Multiple Sclerosis Society as part of a comprehensive approach to MS research and treatment, focusing on accelerating commercial development of promising research discoveries. Through Fast Forward, the Society connects university-based MS research with private-sector drug development and funds small biotechnology/pharmaceutical companies to develop innovative new MS therapies and repurpose FDA-approved drugs as new treatments for MS. For more information, please visit or more information, please visit www.nationalmssociety.org/fast-forward//index.aspx.

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