RegeneRx Biopharmaceuticals, Inc. announced a clinical trial update provided by GtreeBNT, RegeneRx's partner for development of RGN-259 and RGN-137 in the U.S. Regarding progress on ARISE-3, the manufacturing of the investigational product for ARISE-3 has been completed and the protocol for the study has been finalized and is now ready for the study. Also, since funding for the ARISE-3 clinical study is progressing smoothly towards the final stage, The company will do their best to inform the customer of ARISE-3 study initiation as soon as possible. The company also hope that their potential discussions with multinational pharmaceutical companies for a deal will accelerate the process by launching the ARISE-3 clinical trial.

ARISE-3 is the designation for the phase 3 clinical trial for RGN-259, RegeneRx's sterile, preservative-free, eyedrop to treat dry eye syndrome and other corneal wound disorders. The production of investigational product for an Open Study has been completed. The company also have a signed a contract with the clinical sites where recruitment of EB patients will start soon.

In terms of the regulatory aspect, the FDA already approved the company's open study protocol. The company are currently preparing for the final clinical trial with the goal of FPFV (first patient first visit) to occur in November 2018. In June of this year, the U.S. FDA has announced new guidelines solely for EB, and The company is currently revising the company study design for Phase 3 in accordance with the new FDA guidelines.

The company is preparing to enter the clinical trial phase 3 in 2019. The company's open study which is starting now is expected to make a decisive contribution to setting up a strategic clinical phase 3 study incorporating the new U.S. FDA guidelines. The EB clinical trial is to test RGN-137, RegeneRx's dermal gel for wound healing in epidermolysis bullosa patients.

EB is an orphan disease in the U.S. and EU.