Cerecor Announces First Patient Enrolled in Phase I Trial for Neurogenic Orthostatic Hypotension (nOH) in Parkinson’s Disease
Study to evaluate safety, tolerability and effects on blood pressure of CERC-301 in patients with nOH
BALTIMORE, Md., Aug. 01, 2018 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), today announced that it has enrolled the first patient in a Phase I study of its proprietary drug candidate CERC-301 in patients with neurogenic Orthostatic Hypotension (nOH) associated with Parkinson’s disease. The study will evaluate the single-dose safety, tolerability and pharmacokinetics of CERC-301 in this patient population, as well as explore the effects on blood pressure and symptoms of nOH during an orthostatic challenge at escalating dose levels.
Peter Greenleaf, Chief Executive Officer of Cerecor, commented, "With the first patient enrolled in our Phase I trial, we are now actively studying CERC-301 in nOH. We are excited about the progress that our team has made in advancing the clinical development of CERC-301, which demonstrates the potential of our pipeline. We are transforming Cerecor into a fully integrated innovation driven Specialty Pharmaceutical Company. Our intent is to leverage the profits of our commercial portfolio as fuel for innovation to support our clinical development programs.”
Dr. Stuart Isaacson, Director, Parkinson’s Disease and Movement Disorders Center of Boca Raton, Associate Professor of Neurology, Herbert Wertheim College of Medicine and lead investigator for the study, commented, “We are extremely excited about this compound. There is a substantial unmet need in this area for Parkinson’s patients. What we like about the compound is that it’s previously been evaluated in patients with Parkinson’s and though small numbers, we have not seen any serious adverse events, so we hope it will be safe and well tolerated and offer a new option into the management of nOH in patients with Parkinson’s Disease as it progresses in its evaluation.”
nOH is an orphan disease resulting from failure of the autonomic nervous system to regulate blood pressure in response to postural change, due to an inadequate release of norepinephrine. 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, fludrocortisone, pyridostigmine, atomoxetine).
About the nOH Study
This is a single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of CERC-301 in patients with symptomatic nOH associated with Parkinson's disease. This is a multi-center study in the United States, with data expected in the first half of 2019.
CERC-301 is an oral, NR2B specific N-methyl-D-aspartate receptor antagonist Cerecor is developing for treatment of nOH. In previous clinical studies, CERE-301 has demonstrated a pressor effect on blood pressure in healthy volunteers, Parkinson’s disease patients and patients with Major Depressive Disorder. We believe CERC-301 has the potential to be a first-in-class medication that reduces symptoms of nOH.
Cerecor is a biopharmaceutical company focused on the near-term goal of becoming the leading U.S. pediatric pharmaceutical company while developing innovative therapies that make a difference in the lives of patients. The Company’s pipeline is led by CERC-301, which Cerecor currently intends to explore as a novel treatment for orphan neurologic indications. Cerecor is also developing two pre-clinical stage compounds, CERC-611 and CERC-406. The Company’s R&D efforts are supported by revenue from its franchise of commercial medications led by Poly-Vi-Flor® (multivitamin and fluoride supplement tablet, chewable) and Tri-Vi-Flor® (multivitamin and fluoride supplement 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 of trial results, 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; Cerecor’s cash position and the potential need for it to raise additional capital; risks associated with acquisitions, including the need to quickly and successfully integrate acquired assets and personnel; 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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Released August 1, 2018