Cerecor Announces Peer-Reviewed Publication Highlighting the Role of the Inflammatory Cytokine, LIGHT, in COVID-19 ARDS - Seite 2

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.

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 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.