3 Promising Maryland Biotechs that are Targeting Neurological Disorders
BrainScope, AgeneBio and Neuraly
February 13, 2019
Neurological disorders are diseases of the central nervous system such as Alzheimer’s and Parkinson’s. Neurological issues can also result from strokes and traumatic head injuries. These disorders affect millions of people worldwide, and the annual cost of care in the U.S. alone exceeds $789 billion.
Current neurological disorder treatments are mostly focusing on symptom reduction and pain management, but a new breed of companies are now taking a different approach. There is a huge unmet need to develop drugs or molecules that can slow disease progression and enhance early identification of disease markers to enhance the standard of care.
These three Maryland companies are focused on this unmet need, and all have promising technology that could impact this patient population greatly.
BrainScope, founded in 2006, is a commercial stage medical neurotechnology company headquartered in Bethesda, MD. The company’s main focus is assessing traumatic brain injuries, including concussions. The company has developed and commercialized the FDA approved BrainScope® One, a handheld product to empower physicians to make quick and accurate assessments for mild-head injuries within the previous 72 hours.
BrainScope has raised over $32 million in U.S. Department of Defense research funding for the development of its technology, in addition to private investment from the Maryland Venture Fund and Revolution LLC. BrainScope has been nominated twice, in 2017 and 2018, for the Prix Galien Foundation U.S.A Award for Best Medical Technology Product. BrainScope was also named as Maryland’s Emerging Life Science U.S. Business of the Year award winner in 2016.
Developed using electroencephalogram (EEG) technology, advanced signal processing, machine learning technologies, and sophisticated algorithms, BrainScope® One identifies and assess the brain’s electrical activity during a mild traumatic brain injury (mTBI). When someone has a brain injury, the electric signals of the injured brain are different from those who are uninjured. BrainScope One has the ability to assess the normal and injured brain’s electrical activity to identify mTBI in patients. The rapid identification of brain injury in terms of brain structure and function at the point of care provides a dramatic improvement to treat patients with mTBI or concussion.
AgeneBio is a clinical-stage pharmaceutical company located in Baltimore, MD with multiple late-stage assets. Founded in 2008 out of research conducted at John Hopkins University, AgeneBio is venturing to identify novel drugs that can restore and recover brain function for neurodegenerative disease patients.
The company’s lead drug is AGB101, a potential treatment for MCI due to Alzheimer’s disease. After a successful phase 2 clinical trial (known as the HOPE4MCI trial), the National Institute of Aging (NIA) awarded AgeneBio approximately $16 million to fund the phase pivotal 3 trial. AGB101 is a proprietary, extended release formulation of levetiracetam, an FDA-approved anti-epileptic drug, that targets overactivity in the hippocampus that can cause mild cognitive impairment (MCI) in patients with neurological disorders like Alzheimer’s.
Another program in the AgeneBio pipeline is a GABAA-α5 positive allosteric modulator program, a late discovery stage program with potential indications for Alzheimer’s disease, schizophrenia and autism. The hippocampus has high expression of GABAA-α5 receptors. The allosteric modulators to GABAA-α5 can decrease and control the overactivity of the hippocampus. This program was funded by the Blueprint Neurotherapeutics (BPN) Network Program, which is part of the NIH Blueprint for Neuroscience Program.
Neuraly is an early development-stage biopharmaceutical company founded in 2018 based on research and technology developed at the John Hopkins School of Medicine. Now located at the Germantown Innovation Center (GIC), their focus is on the development of drugs that can help in the successful treatment of neurodegenerative diseases like Parkinson’s and Alzheimer’s.
Lead by industry veteran Viktor Roschke, Neuraly’s chief scientific officer, the company has secured $36 million from the holding company, D&D Pharmatech with participating Korean venture funds. Locally, Maryland Venture Fund and Octave Life Sciences have also provided financing to the company.
Most of the drugs available in the market are helpful to reduce or manage the symptoms but not for treating the disease. Neuraly is seeking to identify new drugs that can improve the lives of patients suffering from the disease, and their lead compound, NLY01, aims slow the disease progression by blocking glial cell activation. Glial cells support brain function; however, in diseased states, the cells become neurotoxic. “We expect NLY01 to be a pioneering treatment for Parkinson’s with low development risks,” shared Roschke. “we have seen unprecedented efficacy in pre-clinical models and well-characterized safety profiles in a similar class of molecules.”
Phase 1 clinical trials for NLY01 were targeted for late 2018. Two other products in early stage development include NLY02 and NLY03. NLY02 is a kinase inhibitor that targets glial cell activation while NLY03 targets the neuronal survival pathways. Keep an eye on this company as they move these products forward.