ROCKVILLE, Md. and CHESTERBROOK, Pa., Aug 13, 2020 (GLOBE NEWSWIRE via COMTEX) -- Cerecor Inc. /zigman2/quotes/201368871/composite CERC +3.04% , a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, today announced the publication of a peer-reviewed paper demonstrating significantly elevated free LIGHT levels in the serum of hospitalized patients with severe COVID-19 infection. The publication, entitled Levels of the TNF related cytokine, LIGHT, increased in hospitalized COVID-19 patients with Cytokine Release Syndrome and ARDS in the Journal mSphere by David S. Perlin et al, highlights the potential role of the inflammatory cytokine, LIGHT in the development of COVID-19 ARDS. Cerecor believes that the publication supports its clinical program evaluating CERC-002, the only clinical stage anti-LIGHT monoclonal antibody, as a potential treatment for patients with severe COVID-19 acute respiratory distress syndrome ("ARDS"). A link to the publication can be accessed here.
Dr. Perlin, chief scientific officer, senior vice president of the Center for Discovery and Innovation, and Professor of Medical Sciences at the Hackensack Meridian School of Medicine, said, "Identifying the role of LIGHT in patients infected with SARS-CoV-2 ("COVID-19") is a seminal finding pointing to understanding the potential mechanism by which COVID-19 infection leads to ARDS and suggests a promising new strategy to treat these patients."
"We believe these compelling results strongly support our hypothesis that LIGHT plays an important role in COVID-19 ARDS and indicated that a clinical trial of CERC-002 in COVID-19 ARDS was a logical next step," said Dr. Garry Neil, chief scientific officer at Cerecor. "This study is now well underway, and we expect topline results in the fourth quarter of 2020. We are further exploring the potential role of LIGHT as a driver of and biomarker for ARDS in additional studies of both COVID-19 infected patients as well as in a broader patient population of non-COVID-19 associated ARDS patients. From these studies we hope to learn more about the role of LIGHT in ARDS in general, while potentially opening a path for treatment of a broader population of ARDS patients who have high mortality and, in many cases, lack effective treatment options."
Role of LIGHT in Acute Inflammatory Response
LIGHT (homologous to Lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocytes) is a cytokine with inflammatory actions encoded by the Tumor Necrosis Factor Super Family 14 gene. LIGHT has been shown to play a key role in the immune response to viral pneumonia. LIGHT plays an important role in regulating immune responses in the lung, gut and skin. It stimulates T Cell and B Cell response as well as induces the release of other cytokines such as IL1, IL6, IL-8, IL-10, TNF and GM-CSF.
CERC-002 (anti-LIGHT monoclonal antibody)
CERC-002 is a first in class fully human anti-LIGHT (TNFSF14) monoclonal antibody licensed from Kyowa Kirin Co., Ltd. It offers the potential to treat cytokine release syndrome-induced COVID-19 ARDS in the near-term and broader ARDS indication beyond. It is currently being developed as a treatment for pediatric Crohn's disease and now cytokine release syndrome induced COVID-19 ARDS. Cerecor has also developed a validated serum/plasma free LIGHT assay in collaboration with Myriad RBM. This assay has shown to have high sensitivity and specificity for free LIGHT which has been shown to be elevated in patients with active Crohn's disease and with COVID-19 related ARDS.
About the CERC-002 COVID-19 ARDS Trial
Cerecor is sponsoring a randomized, multicenter U.S., double-blind, placebo-controlled clinical study that will enroll approximately 82 subjects hospitalized with COVID-19 ARDS. The primary objective of the study is to demonstrate that treatment with CERC-002 results in fewer instances of respiratory failure and death versus the standard of care. Patients in the CERC-002 arm will receive a single dose of drug and be followed for 28 days. Key secondary endpoints include intensive care unit length of stay, hospital length of stay, and oxygen saturation at the end of the study. The trial is currently underway and enrolling patients in the U.S. with topline data expected in the fourth quarter of 2020.
Cerecor is a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases. The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare pediatric and orphan diseases. The company's pediatric rare disease pipeline includes CERC-801, CERC-802 and CERC-803 ("CERC-800 compounds"), which are therapies for inherited metabolic disorders known as congenital disorders of glycosylation. The U.S. Food and Drug Administration ("FDA") granted Rare Pediatric Disease Designation ("RPDD") and Orphan Drug Designation ("ODD") to all three CERC-800 compounds, thus potentially qualifying the Company to receive a Priority Review Voucher ("PRV") upon approval of each new drug application ("NDA"). The company is also developing CERC-002, CERC-006 and CERC-007. CERC-002 is an anti-LIGHT monoclonal antibody being developed for the treatment of COVID-19 acute respiratory distress syndrome and pediatric-onset Crohn's disease. CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex lymphatic malformations and has been granted ODD and RPDD by the FDA, thus potentially qualifying the company to receive a fourth PRV upon approval of an NDA. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as adult onset Stills disease and multiple myeloma.
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," "might," "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; potential attributes and benefits of product candidates; 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, including reliance on investigators and enrollment of patients in clinical trials, which might be slowed by the COVID-19 pandemic; regulatory risks; Cerecor's cash position and the potential need for it to raise additional capital; general economic and market risks and uncertainties, including those caused by the COVID-19 pandemic; 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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