HLB Therapeutics said Monday that it would simultaneously start clinical trials for neuroparalytic keratitis treatment in the U.S. and Europe, signing related contracts with a global contract research organization (CRO).

Eye disease drugs usually require two repetitive clinical outcomes. However, HLB plans to reduce the trial period by conducting the two clinical trials of SEER-2 and SEER-3 simultaneously in the U.S. and Europe, according to the company.

HLB’s U.S. subsidiary ReGenTree is developing the neuroparalytic keratitis (NK) treatment.

In phase 3 clinical trial, researchers will administer HLB Therapeutic’s novel drug substance RGN-259 to 60 NK patients in the U.S. and Europe. RGN259 is a candidate substance for ophthalmologic disease as it accelerates cell movement through thymosin beta 4 (Tβ4) medicinal substance and secures diverse potential such as anti-inflammatory and injury treatment.

In the first phase trial (SEER-1), the company confirmed a significant p-value, albeit from a relatively small number of 18 patients, but had to suspend trials temporarily due to lack of funds. However, after the HLB Group took over the company, it decided to push ahead with two clinical trials at once, seeing a high possibility of success on the candidate substance, it said.

A clinical trial for NK can receive swift approval if the drug proves efficacy and safety, as its primary endpoint is the complete healing of the illness. In contrast, xerophthalmia, a more common eye disease, has difficulty satisfying the patients’ symptoms and physicians’ sign index.

Oxervate, a treatment developed by Italy’s Dompe, is prescribed in the U.S. as a sole treatment. However, patients experience a financial burden as it costs more than $50,000 (65.8 million won) a month.

Expectations are high for the upcoming trial as the CRO, which closed a deal with ReGenTree, has diverse clinical trial experiences, participating in Oxervate’s clinical trial, the company said.

“Since HLB Therapeutics was incorporated into the HLB group, it has aimed to produce operating profit as a short-term goal and to commercialize new drugs as a mid-term goal,” HLB Therapeutics CEO Ahn Ki-hong said. “We will increase the possibility of commercializing new drugs by injecting development funds in adding indications for rare diseases.”

Neuroparalytic keratitis has a relatively large market for a rare disease as there are about 20,000 new patients in the U.S.