Eloxx Pharmaceuticals Inc. (Nasdaq: ELOX), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ELX-02, a drug candidate intended to treat cystic fibrosis patients with nonsense mutations. ELX-02 is currently in Phase 2 clinical trials in CF patients affected by nonsense mutations in the CFTR (CF transmembrane conductance regulator) gene for whom there are no effective disease modifying therapies. The Phase 2 trials are designed to evaluate the safety of ELX-02 and assess its biological activity, and Eloxx expects to present data from the first four treatment arms in the fourth quarter of 2021.
“We are delighted to receive Fast Track Designation from the FDA for ELX-02 as the need for patients remains significant. The ability to have greater access to the FDA and their guidance on the regulatory pathway for ELX-02 can help provide the ability to work with the urgency needed on behalf of CF patients with nonsense mutations,” said Sumit Aggarwal, President and CEO of Eloxx.
Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the provision is to help facilitate development and expedite the review of drugs to treat serious or life-threatening conditions so that an approved product can reach the market expeditiously. Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.
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