CereNovo is a North Carolina based start up that is developing a biologic to treat the neurological damage caused by traumatic brain injury and stroke. CereNovo is currently seeking $1.5 MM to proceed with  preclinical IND-enabling studies. CereNovo intends to use the $50,000 prize money, in conjunction with other non-dilutive capital to incorporate, license, and continue preclinical studies.  To further explain our value proposition we have created a short 5-minute video.

Every 40 seconds, someone in the United States has a stroke. This number adds up to 795,000 strokes a year. The statistics for traumatic brain injury (TBI) are similar with 1.5 million TBIs occurring each year in the United States; of this number, 275,000 TBI patients are hospitalized and 43% suffer long-term cognitive, motor, and emotional changes. The total direct medical cost, including both acute and long-term care, of TBI and stroke is approximately $89 billion per year. After the initial insult to the brain (trauma/bleeding/infarct), it is vital for a patient’s survival and recovery to prevent further brain deterioration (secondary damage). However, the major problem with treating stroke and TBI is that current treatment is merely palliative and focuses on stabilizing the patient’s intracranial pressure, cerebral blood flow, and oxygen supply. No treatment today effectively addresses the secondary neurological damage caused by the body’s immune response after a brain-injuring event. The lack of an FDA approved drug to effectively treat TBI and stroke shows a clear unmet need for these patients.

CereNovo, a North Carolina based start up, addresses this need by creating a proprietary neuro-protective biologic called CN-1.  It reduces neuronal degeneration and death by shielding the brain from the secondary damage derived from inflammation after a stroke/TBI event. CN-1 achieves its therapeutic effect by mimicking apoE, a protein found in the brain that reduces inflammation after brain injury. Animal studies have revealed that CN-1 not only diminishes neural degeneration and death, but also improves recovery of motor and cognitive functions. Clinicians surveyed on CN-1’s potential used words like “fascinating”, “exciting” and “important” to express their interest in the CN-1 biologic.

CN-1 is targeting two global market segments: TBI and stroke. The estimated annual TBI market exceeds $500 million both in the United States and Europe. The global TBI therapeutics market was worth $1.54 billion in 2010, growing at an estimated 3.8% for seven years, and is expected to reach $2 billion by 2017. The global market for stroke was valued at approximately $3.0 billion in 2008.  It is forecast to grow at a CAGR of 3.4% and projected to reach $3.6 billion by 2015.

For the next 2-4 years, CereNovo will be performing preclinical testing such as: 1) toxicology and PK/PD studies, 2) a primate dose escalation and/or Phase 0 human micro-dosing efficacy study, and 3) manufacturability and formulation testing. After preclinical testing is completed, an IND application will be submitted to the FDA and Phase I-III human clinical trials will begin, running for approximately 6 years. Upon completion, a Biologic License Application (BLA) will be submitted to the FDA for approval. 

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