HLB Therapeutics (HLBT) has signed a letter of intent to engage an international ophthalmology contract research organisation (CRO) to carry out two Phase III trials of RGN-259 in neurotrophic keratitis (NK) patients in the US and Europe. However, HLBT did not name the CRO in its media release.
These simultaneous trials will commence in September this year in the US and Europe. The purpose of carrying out these trials at the same time is to cut down the time needed to conclude Phase III development.
HLBT noted that NK trials need a single primary endpoint, such as complete healing as against dry eye disease (DED).
HLBT is a US joint venture (JV) partner and licensee of RegeneRx Biopharmaceuticals.
A sterile, preservative-free, eye drop, RGN-259 was developed for lowering damage and enhancing healing for several ophthalmic indications including neurotrophic keratopathy and dry eye syndrome.
Thymosin beta 4 is the product’s active pharmaceutical ingredient and showed several mechanisms of action, including boosting cell migration, healing of the wound, cytoprotection as well as anti-inflammatory effects.
The decision to commence these trials for NK is based on findings from the SEER-1 study.
Commenting on the development, RegeneRx J J Finkelstein president and chief executive said: “We are pleased HLBT is continuing to move forward with both NK and DED clinical trials with RGN-259 as previously discussed.
“Accelerating NK clinical development by simultaneously conducting two trials will speed up the process while also working with the FDA under an SPA to refine our approach to DED.”
So far, more than 1,700 participants received RGN-259 treatment showing various levels of efficacy in DED and NK.
Furthermore, the eye drop also demonstrated to be rapidly acting, well-tolerated and does not have any documented side effects linked with other products for such indications.