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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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. 

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.