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Cerecor Inc. (NASDAQ: CERC) announced that the FDA has accepted its IND application to study CERC-007 for treating Adult Onset Still's Disease (AOSD). The global multicenter Phase 1b trial will start in Q1 2021, enrolling around 12 patients to evaluate safety and preliminary efficacy. CERC-007 is a high-affinity monoclonal antibody targeting IL-18, a pro-inflammatory cytokine linked to AOSD. The company is also advancing its pipeline of therapies for rare diseases, including other candidates with Orphan Drug Designation.
Cerecor Inc. (NASDAQ: CERC) has initiated a Phase 1b clinical trial of CERC-007 for relapsed or refractory multiple myeloma, marking a significant milestone in its development pipeline. The trial aims to assess the safety, tolerability, and preliminary efficacy of CERC-007, a fully human anti-IL-18 monoclonal antibody. Initial data is expected in Q1 2021. With approximately 140,000 patients diagnosed in the U.S., the need for novel therapies in multiple myeloma is critical, given its high mortality rate.
Cerecor Inc. (NASDAQ: CERC) announced the acceptance of its Investigational New Drug Application (IND) for CERC-007 to treat relapsed or refractory multiple myeloma by the FDA. A multicenter Phase 1b clinical trial will commence, involving approximately 30 patients. The trial aims to assess safety, dose, and preliminary efficacy, with initial data expected by Q1 2021. Multiple myeloma, affecting around 140,000 patients in the U.S., has a poor survival rate despite new treatments. CERC-007 is also under development for other autoimmune diseases.
Cerecor Inc. (CERC) announced that the FDA accepted its Investigational New Drug Application for CERC-803 to treat Leukocyte Adhesion Deficiency Type II (LAD-II). A pivotal trial is expected to start in the first half of 2021, with topline data anticipated later that year. Both Orphan Drug Designation and Rare Pediatric Disease Designation were granted for CERC-803, which may lead to a Priority Review Voucher upon new drug application approval. The company targets rare diseases with innovative therapies, including CERC-801 and CERC-802.
Cerecor Inc. (NASDAQ: CERC) announced a collaboration with The Frontiers in Congenital Disorders of Glycosylation Consortium to conduct a pivotal trial on CERC-801 for patients with Phosphoglucomutase-1 deficiency (PGM1-CDG). This study will assess the drug's safety, tolerability, and efficacy, leveraging data to support an FDA submission for the treatment of this rare condition. Currently, there are no approved therapies for PGM1-CDG, marking a significant potential advancement for patients suffering from this disorder.
Cerecor Inc. (CERC) reported progress on its clinical trial for CERC-002, targeting COVID-19 ARDS, poised for completion by year-end 2020. The firm appointed Dr. Gilla Kaplan to its Board, enhancing its leadership in immunology. Financially, Cerecor faced challenges with a decrease in cash to $33.4 million, operating expenses rising to $14.4 million, and a net loss of $13.5 million for Q3 2020. R&D costs surged to $8.9 million, reflecting ongoing advancements in its drug pipeline, including CERC-007 for multiple myeloma.
Cerecor Inc. (NASDAQ: CERC) announced the appointment of Dr. Gilla Kaplan to its Board of Directors. Dr. Kaplan brings over 30 years of experience in academia and the biopharmaceutical industry, especially in immunology. Her previous roles include Director of the Global Health Program at the Bill and Melinda Gates Foundation. Cerecor is advancing its innovative pipeline targeting rare and orphan diseases, including treatments for metabolic disorders and COVID-19 related conditions. Dr. Kaplan's expertise is expected to support the company's clinical development goals.
Cerecor Inc. (NASDAQ: CERC) announced that Michael F. Cola, President and CEO, will present at two upcoming virtual conferences: H.C. Wainwright 22nd Annual Global Investment Conference on September 14, 2020, at 3:00 PM ET and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 21, 2020, at 1:40 PM ET. Cerecor focuses on developing treatments for rare and orphan diseases, with a pipeline including CERC-800 compounds for inherited metabolic disorders and CERC-002 for Crohn's disease. The presentations will be accessible via the company's website.
Cerecor Inc. (NASDAQ: CERC) has resumed its Phase 1b clinical study of CERC-002, aimed at treating anti-TNF refractory Crohn’s disease patients, after the lifting of a moratorium related to COVID-19. CERC-002 is a first-in-class fully human anti-LIGHT monoclonal antibody also being evaluated in patients with COVID-19 ARDS. Topline results from the study are anticipated in Q1 2021. The company continues to advance its pipeline, including other compounds for rare diseases, with promising regulatory designations.
Cerecor Inc. (NASDAQ: CERC) announced a peer-reviewed publication revealing elevated free LIGHT levels in hospitalized COVID-19 patients, suggesting a link to cytokine release syndrome and ARDS. This supports the company's clinical program for CERC-002, an anti-LIGHT monoclonal antibody aimed at treating severe COVID-19 ARDS. The randomized trial, enrolling 82 patients, aims to show that CERC-002 can reduce respiratory failure and mortality rates. Topline results are expected in Q4 2020, with hopes to expand research on LIGHT as a treatment target beyond COVID-19.
