- 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, USA I May 05, 2021 I 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 40% of AOSD patients have severe chronic disease2.
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.
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.
SOURCE: Cerecor
Post Views: 94
- 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, USA I May 05, 2021 I 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 40% of AOSD patients have severe chronic disease2.
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.
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.
SOURCE: Cerecor
Post Views: 94
