Posted by Michael Wonder on 13 Feb 2019
Neurotech Pharmaceuticals granted fast track designation from the U.S. FDA for the treatment of macular telangiectasia type 2
12 February 2019 - Neurotech Pharmaceuticals announced today that the U.S. FDA has granted fast track designation for the Company's development candidate, NT-501 or Renexus for the treatment of macular telangiectasia type 2.
Renexus is a novel cell-based drug delivery system. Human-derived cells encapsulated in a semipermeable hollow fiber membrane device release ciliary neurotrophic factor (CNTF) demonstrated to reduce photoreceptor cell loss in animal models of retinal degeneration. The implanted Renexus device results in sustained delivery of CNTF localised to the retina, the light-sensing tissue in the back of the eye. MacTel is a rare macular degenerative disease typically diagnosed in middle age. Patients rarely experience total vision loss, but the disease nonetheless has a significant impact, through visual loss, on a patient's quality of life.
In a multi-center, randomised, controlled Phase 2 clinical study of MacTel, Renexus was shown to slow the progression of retinal degeneration compared with participants who received the sham treatment. Based on the positive Phase 2 results, two parallel Phase 3 studies were initiated and are currently enrolling patients in the United States, Australia, and Europe to determine the safety and efficacy of Renexus for the treatment of MacTel (NCT03319849, NCT03316300). These studies are sponsored by Neurotech in collaboration with the Lowy Medical Research Institute (LMRI).
