Cerecor Announces Exploration of the Role of an Inflammatory Cytokine, LIGHT, in COVID-19 Patients with Acute Lung Injury Leading to Acute Respiratory Distress Syndrome

ROCKVILLE, Md., March 26, 2020 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare pediatric and orphan diseases, today announces that it will explore the role of an inflammatory cytokine, LIGHT, in patients with COVID-19 induced Acute Respiratory Distress. The Company will use its proprietary free LIGHT assay as well as a multiplex assay to determine whether there are differences in LIGHT levels and other inflammatory markers including IL-18 and IFN-g in patients with mild to moderate vs severe disease with Acute Lung Injury / Acute Respiratory Distress Syndrome (“ARDS”).

Dr. Garry Neil, Chief Medical Officer for Cerecor, commented, “We know there is accumulating evidence that suggest that the main cause for morbidity and mortality from COVID-19 is a dysregulated immune response causing a “cytokine storm” that can exacerbate lung injury and in some patients cause Acute Respiratory Distress Syndrome (ARDS) and even fatal respiratory failure. We believe there is a strong mechanistic rationale for anti-LIGHT therapy in patients infected by COVID-19 who progress to ARDS.”

COVID-19 and Auto-Inflammatory Response
Dysregulated inflammatory response and cytokine storm in patients with acute infection leading to respiratory distress and failure is well documented. Many of these patients require intensive care and ventilation owing to emergence of acute respiratory distress syndrome (ARDS) which is a well-described and potentially fatal complication of other viral respiratory syndromes (i.e., SARS, MERS, and H1N1).

In COVID-19 and other human corona respiratory virus (hCoV) infections, ARDS appears to result from a dysregulated hyperinflammatory response manifested by the release of excessive pro‐inflammatory cytokines and chemokines, coined a “cytokine storm”. This cytokine storm can drive acute lung injury and multiple system organ failure.

In addition, reports indicate that pulmonary fibrosis, which is known to be a result of ARDS, is a known COVID-19 infection complication. The cytokine storm that drives tissue injury and vascular permeability in the lungs is likely mediated, in part by T cell, monocytes and macrophages activation with increased expression of cytokines.

Role of LIGHT in Acute Inflammatory Response 
An important immunoregulatory cytokine, LIGHT (homologous to lymphotoxin, exhibits inducible expression and competes with HSV glycoprotein D for binding to herpesvirus entry mediator, a receptor expressed on T lymphocyte) is secreted in high levels during viral infection. Early in infection, LIGHT is released from neutrophils and macrophages, bind its cellular receptors, which causes inflammatory cell infiltration and the release of high levels of TNF and additional pro-inflammatory cytokines. LIGHT also has a co-stimulatory role in T cell activation driving proinflammatory and tissue damaging effects. Neutrophils and macrophages express high levels of LIGHT and TNF and are a major source of these inflammatory cytokines. Moreover, LIGHT has a key role in driving pulmonary fibrosis via well characterized mechanisms. Therefore, neutralizing LIGHT may be beneficial for severe COVID-19 infection who are at high risk of ARDS and respiratory failure.

About Cerecor

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 an emerging clinical-stage pipeline of innovative therapies. The Company’s pediatric rare disease pipeline is led by CERC-801, CERC-802 and CERC-803 (“CERC-800 programs”), which are therapies for inborn errors of metabolism, specifically disorders known as Congenital Disorders of Glycosylation (”CDGs”). The FDA granted Rare Pediatric Disease Designation and Orphan Drug Designation (“ODD”) to all three CERC-800 programs, thus potentially qualifying the Company to receive a Priority Review Voucher (“PRV”) upon approval of a new drug application (“NDA”). The Company is also developing CERC-002, CERC-006 and CERC-007. CERC-007 is an anti-IL-18 monoclonal antibody being developed for the treatment of autoimmune inflammatory diseases such as Adult Onset Stills Disease (“AOSD”) and Multiple Myeloma (“MM”). CERC-006 is a dual mTOR inhibitor being developed for the treatment of complex Lymphatic Malformations. CERC-002 is an anti-LIGHT monoclonal antibody being developed for the treatment of Pediatric-onset Crohn’s Disease. 

For more information about Cerecor, please visit www.cerecor.com.

Forward-Looking Statements

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; 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; regulatory risks; Cerecor's cash position and the 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.

For media and investor inquiries

James Harrell,
Investor Relations
Chief Commercial Officer
Cerecor Inc.
jharrell@cerecor.com
623.439.2220 office

Released March 26, 2020