Cerecor Announces Positive Interim Results of CERC-301 in the Treatment of Neurogenic Orthostatic Hypotension (nOH)
ROCKVILLE, MD / ACCESSWIRE / April 15, 2019 / Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, today announced positive interim results from the Phase I study of CERC-301, an NMDA receptor antagonist, being developed for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in Parkinson's Disease.
CERC-301 is an orally available, NR2B-specific, NMDA receptor antagonist being developed for the treatment of symptomatic neurogenic orthostatic hypotension (nOH). NMDA receptor overactivation is associated with many neurodegenerative diseases, including Parkinson's disease.
All doses showed clinically meaningful increases over placebo, within the 6-hour post-dose timepoints. The top-line results demonstrate a rapid, robust increase in systolic blood pressure (SBP) from baseline to 6 hours. The highest dose demonstrated an improvement in SBP of 15.6 mmHg at 1-hour post-dose that continued to improve, ultimately reaching 26.7 mmHg in SBP over baseline at the last study measurement (6 hours post-dose). This early and sustained effect could differentiate CERC-301 from existing nOH treatments. Additionally, all doses tested were safe and well tolerated with no serious adverse events reported.
"We are extremely pleased with the results from this interim analysis as they confirm that CERC-301, a selective inhibitor of the NMDA receptors, provides meaningful increases in blood pressure in patients suffering from nOH. On the basis of these robust data and excellent safety profile, we are committed to the further development of CERC-301 for Parkinson's patients suffering from nOH and expanding to other conditions complicated by low blood pressure," stated Dr. Perry Calias, Ph.D., Cerecor CSO.
Dr. Stuart Isaacson, Director, Parkinson's Disease and Movement Disorders Center of Boca Raton, Associate Professor of Neurology, Herbert Wertheim College of Medicine and the Study's Lead Investigator, noted, "These are incredibly encouraging results for this compound. The magnitude of BP increases and consistent duration of these increases, coupled with a favorable safety and tolerability profile make this a promising candidate to add to our limited armamentarium of treatment options for patients with nOH."
About the Study
This was a phase 1, single escalating dose, placebo-controlled study to assess the safety, tolerability, and pharmacodynamics of CERC-301 in patients with nOH associated with Parkinson's disease. Patients were randomized to one of four treatment arms where they received single escalating doses of CERC-301 at 8mg, 12mg, 16mg, or placebo over 4 study visits. All patients received placebo during at-least one study visit. Patients returned for a fifth study visit and were randomized again to receive either CERC-301 at a dose of 20mg or placebo. At each visit, patients completed 6 Orthostatic Standing Test (OSTs) over a 6-hour period.
About Neurogenic Orthostatic Hypotension (nOH)
nOH is a rare disease resulting from failure of the autonomic nervous system to regulate blood pressure in response to postural change such as standing up. nOH is observed in several neurodegenerative diseases, including Parkinson's disease (PD), multiple systems atrophy, primary autonomic failure, and non-diabetic autonomic neuropathy. The Company believes that nOH constitutes an area in which there is still significant unmet medical need.
Current treatment options for nOH target symptom burden reductions to increase quality of life such as correcting aggravating factors (i.e. discontinuation of hypotension drugs and correction of anemia and vitamin deficiencies); nonpharmacologic measures such as intravascular volume expansion, increased physical activity, reduction of meal size, compression stocking/abdominal binder, and sleeping arrangement; and drug therapies (i.e. droxidopa, midrodrine).
Cerecor is a biopharmaceutical company focused on becoming a leader in the development of orphan neurologic and pediatric therapies that make a difference in the lives of patients. The Company's pipeline is led by CERC-301, which Cerecor is currently exploring as a novel treatment for neurogenic orthostatic hypotension. Cerecor has six additional programs in development, including CERC-406 for Parkinson's Disease, CERC-611 for epilepsy, CERC-801, CERC-802, and CERC 803 for Congenital Disorders of Glycosylation and CERC-913 for DGUOK Deficiency a mitochondrial DNA Depletion Syndrome. The Company's R&D efforts are supported by revenue from its franchise of commercial medications led by Poly-Vi-Flor® and Tri-Vi-Flor® (multivitamin and fluoride supplement tablet, chewable and suspension/drops). In February 2018, the Company added to its marketed product portfolio by acquiring Karbinal™ ER, AcipHex® Sprinkle™, Cefaclor for Oral Suspension, and Flexichamber™.
For more information about Cerecor, please visit www.cerecor.com.
This press release may include forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to significant risks and uncertainties that are subject to change based on various factors (many of which are beyond Cerecor's control), which could cause actual results to differ from the forward-looking statements. Such statements may include, without limitation, statements with respect to Cerecor's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "continue," "seeks," "aims," "predicts," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," or similar expressions (including their use in the negative), or by discussions of future matters such as: the development of product candidates or products; timing and success of trial results and regulatory review (including as it may be impacted by government shut-downs), potential attributes and benefits of product candidates; the expansion of Cerecor's drug portfolio; and other statements that are not historical. These statements are based upon the current beliefs and expectations of Cerecor's management but are subject to significant risks and uncertainties, including: drug development costs, timing and other risks; reliance on and the need to attract, integrate and retain key personnel; Cerecor's cash position and the potential need for it to raise additional capital; and those other risks detailed in Cerecor's filings with the Securities and Exchange Commission. Actual results may differ from those set forth in the forward-looking statements. Except as required by applicable law, Cerecor expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Cerecor's expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based.
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SOURCE: Cerecor Inc.
Released April 15, 2019