Business
Eloxx Pharmaceuticals Reports Full Year 2017 Financial and Operating Results and Provides Business Update
Eloxx Pharmaceuticals Reports Full Year 2017 Financial and Operating Results and Provides Business Update.
About this update from Eloxx Pharmaceuticals, Inc.
[{"type":"text","content":"\n\n Company to host webcast and conference call on Tuesday, March 20, 2018 at 8 am ET Management to discuss recent data and progress on development plans\n WALTHAM, Mass., March 19, 2018 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (“Eloxx”) (OTC:ELOX), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel therapeutics to treat cystic fibrosis, cystinosis and other diseases caused by nonsense mutations limiting production of functional proteins, today reported its financial results for the twelve months ended December 31, 2017, and provided an update on its clinical development plans.  “Given the clinical accomplishments in 2017 for our lead product candidate, ELX-02, we are poised to seek regulatory clearance to initiate Phase 2 clinical trials in cystic fibrosis and cystinosis this year,” said Robert E. Ward, Chairman and CEO of Eloxx Pharmaceuticals. “Patients with nonsense mutations have a high burden of disease, and have few, if any, treatment options available. In cystic fibrosis, therapies to address the needs of patients with nonsense mutations have the potential to lead to the next breakthrough in treating this disease state. We are committed to bringing forward therapeutic options which have the potential to transform lives.” ELX-02 in Cystic Fibrosis and Cystinosis ELX-02 is our lead asset and our current development programs are focused on cystic fibrosis and cystinosis patients with diagnosed nonsense mutations. To advance the program, we have held pre-clinical trial application (CTA) discussions with the Federal Agency for Medicines and Health Products (FAMHP) in Brussels, Belgium and pre-IND discussions with the U.S. Food & Drug Administration (FDA) for cystic fibrosis and cystinosis, respectively. Currently, the European Medicines Agency (EMA) has designated ELX-02 as an orphan medicine for the treatment of mucopolysaccharidosis type I (MPS I), and the FDA has granted orphan drug designation to ELX-02 for the treatment of MPS I and for the treatment of Rett Syndrome. We are on-track for an expected mid-2018 submission of our CTA in Belgium for cystic fibrosis.We are on track for an expected mid-2018 submission of our IND for cystinosis.We expect to initiate Phase 2 studies in cystic fibrosis and cystinosis, by the end o...