Cerecor Doses First Patient in a Phase 1b Proof-of-Concept Clinical Trial of CERC-007 for the Treatment of Adult Onset Still’s Disease
Cerecor Inc. (NASDAQ: CERC) announced the dosing of its first patient in a Phase 1b clinical trial for CERC-007, targeting adult onset Still’s disease (AOSD). The trial aims to evaluate the safety and tolerability of this high-affinity, fully human anti-IL-18 monoclonal antibody. Initial data is expected in Q3 2021, with top-line results from a related trial in relapsed or refractory multiple myeloma patients anticipated in H2 2021. AOSD is a rare inflammatory disease affecting approximately 3,500 - 7,000 patients in the U.S. and has significant unmet medical needs.
- Dosing of the first patient in Phase 1b trial for CERC-007 indicates progress in addressing AOSD.
- Anticipated initial data in Q3 2021 could enhance investor confidence.
- CERC-007's mechanism targeting IL-18 could address a significant unmet need in AOSD.
- Reliance on successful enrollment and trial outcomes poses risks to CERC.
- Potential delays in trial results and regulatory review due to external factors.
- Initial data anticipated in the third quarter of 2021
- Top-line data from the ongoing Phase 1b proof of concept clinical trial in relapsed or refractory multiple myeloma patients anticipated in the second half of 2021
ROCKVILLE, Md. and CHESTERBROOK, Pa., May 05, 2021 (GLOBE NEWSWIRE) -- Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that it has dosed its first patient in a Phase 1b open-label dose-escalation clinical trial of CERC-007 in patients with adult onset Still’s disease (AOSD). The Company anticipates initial data to be reported in the third quarter of 2021.
CERC-007 is a high affinity, fully human anti-IL-18 monoclonal antibody (mAb). IL-18 has been demonstrated to have a key role as a marker of disease activity and its concentration correlates with disease severity in AOSD patients. Proof-of-concept of anti-IL-18 therapy has been demonstrated, establishing the clinical utility of this mechanism for patients with AOSD1.
“We are pleased to announce that we have dosed the first AOSD patient with CERC-007. AOSD is a rare auto-inflammatory disease associated with fever, rash, pharyngitis, arthritis, liver disease, and increased ferritin. The initiation of this trial is a critical step toward addressing the urgent unmet need for a treatment option,” said H. Jeffrey Wilkins, MD, Chief Medical Officer of Cerecor.
The Phase 1b clinical trial (NCT04752371) is a global multi-center, open-label trial of CERC-007 that will enroll approximately 12 subjects with active adult onset Still’s disease. The primary objective of the study will be to determine the safety and tolerability of CERC-007 in AOSD patients. Key secondary endpoints include assessing pharmacokinetic profile of CERC-007 and determining the effect of CERC-007 on systemic clinical manifestations and systemic markers of inflammation in subjects with AOSD.
More information about this study and general information about participating in clinical trials can be found at clinicaltrials.gov and on our website at www.cerecor.com.
About Adult Onset Still’s Disease
Adult onset Still's disease is a rare inflammatory disorder affecting approximately 3,500 - 7,000 patients in the U.S.2 and approximately 3,400 - 6,900 patients in Europe2. Symptoms include fever, rash, pharyngitis, arthritis, liver disease, and increased ferritin. Approximately
About CERC-007
CERC-007 is a high affinity, fully human monoclonal antibody targeting the proinflammatory cytokine IL-18. It is in development for multiple auto-immune diseases, including Still’s disease (adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM).
About Cerecor
Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases. The company is advancing its clinical-stage pipeline of innovative therapies that address unmet patient needs within rare and orphan diseases. The company's rare disease pipeline includes CERC-801, CERC-802 and CERC-803, which are in development for congenital disorders of glycosylation and CERC-006, an oral mTORc1/c2 inhibitor in development for the treatment of complex lymphatic malformations. The company is also developing two monoclonal antibodies, CERC-002, and CERC-007. CERC-002 targets the cytokine LIGHT (TNFSF14) and is in clinical development for treatment of severe pediatric-onset Crohn's disease, and COVID-19 acute respiratory distress syndrome. CERC-007 targets the cytokine IL-18 and is in clinical development for the treatment of Still’s disease (adult onset Still’s disease (AOSD) and systemic juvenile idiopathic arthritis (sJIA)), and multiple myeloma (MM). CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval.
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,” “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.
For media and investor inquiries
Chris Brinzey
Westwicke, an ICR Company
chris.brinzey@westwicke.com
339-970-2843
or
Schond L. Greenway
Investor Relations
Chief Financial Officer
Cerecor Inc.
sgreenway@cerecor.com
610-522-6200
1 Gabay C, Fautrel B, Rech J, et al. Open-label, multicentre, dose-escalating phase II clinical trial on the safety and efficacy of tadekinig alfa (IL-18BP) in adult-onset Still's disease. Ann Rheum Dis. 2018 Jun;77(6):840-847.
2 Gerfaud-Valentin M, Jamilloux Y, Iwaz J, Sève P. Adult-onset Still's disease. Autoimmun Rev. 2014;13(7):708-22.
FAQ
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