Complement Therapeutics received FDA fast track for geographic atrophy treatment
Following IND clearance in December, Complement Therapeutics has now received FDA Fast Track Designation for its lead candidate CTx001 for the treatment of geographic atrophy.
CTx001 is a novel adeno-associated virus (AAV)-based gene therapy designed to deliver a truncated version of Complement Receptor 1 (mini-CR1), with the potential for long-term potent modulation of the classical and alternative pathways of the complement cascade. GA is an advanced form of dry AMD that leads to irreversible vision loss, with limited therapeutic options.
Dr. Rafiq Hasan, Chief Executive Officer of Complement Therapeutics, said:
FDA Fast Track Designation for CTx001 is an important regulatory milestone recognising the seriousness of Geographic Atrophy, the unmet medical need faced by patients as well as the innovative potential for CTx001 to meaningfully address this need” . “Together with the recent IND clearance, this designation supports our efforts to efficiently advance CTx001 into clinical development as we work to address a leading cause of irreversible vision loss.
