Huons may give up on the development of HU024, a new biologic drug for dry eye treatment, industry watchers speculated.

On Thursday, Huons filed a public disclosure saying it would withdraw its plan for the local phase-2 clinical trial of HU024 but did not elaborate clearly. Observers said it might signal that the company has virtually nullified the drug development plan.

HU024 is a biologic drug using a recombinant protein called “thymosin beta 4.”

Huons licensed in the thymosin beta 4 from Northland Biotech, a Chinese biopharmaceutical developer, in 2015 to work on HU024.

Huons had expected that wound healing and the anti-inflammatory effect of the thymosin beta 4 could suppress inflammation in the lacrimal glands, the major cause of dry eye syndrome. It could also induce proliferation of “Goblet cells” that secrete mucin, a mucous component in the eye, and fundamentally treat dry eye syndrome, the company had anticipated.

The anticipation for HU024 development was particularly high because it was Huons’ first biologic eye drop treatment.

The company has emphasized that the investigational eye treatment could fundamentally treat the disease, provide an immediate therapeutic effect, and offer less foreign body sensation.

When Huons obtained the regulatory nod for the phase-2 study in October 2020, Huons CEO Eom Gi-an said HU024 was “a new biologic pipeline prepared by Huons, a leading firm in ophthalmology.”

At that time, Eom said the company would confirm the efficacy and safety in the local study first and go on with global trials consecutively.

However, Huons’ Thursday disclosure showed the company notified the Ministry of Food and Drug Safety on Wednesday that it would cancel its local trial of the experimental drug.

The company canceled the investigational new drug (IND) trial “because the ministry ordered the company to submit the results of the non-clinical toxicity test,” Huons said. “Reflecting the ministry’s correction order,” the company decided to withdraw the IND application, it said in the public filing.

Asked why the company did not submit the data but nullified the trial plan, an official at Huons said, “We needed to review the entire data for submission internally, and we thought it would take a considerable amount of time to do so, so we voluntarily nullified the IND development plan.”

However, the ministry said it granted new approval for a changed trial plan, but Huons withdrew it almost immediately. “We approved the study plan on May 10, but the company reported an early ending of the trial on May 13,” an official at the ministry said.

According to Huons and the ministry, Huons changed the phase-2 trial plan at least once after winning the nod for the trial of HU024 in October last year. Then, the ministry recently approved the revised trial plan, but the company decided to stop the trial.

Huons' data submitted to the ministry earlier indicated that the company had planned to proceed with the Phase-1/2a study in 192 healthy people and dry eye patients at the Seoul National University Bundang Hospital, starting this month, to evaluate 0.05 percent and 0.10 percent HU024 eye drop’s efficacy, safety, and pharmacokinetic characteristics.

Huons’ voluntary withdrawal of the HU024 trial indicates that the company may have dropped the entire development plan for the eye treatment, industry watchers said.

“Even if the ministry requested additional data submission, there is no reason for the company to nullify the IND trial plan,” an industry official said.

Asked if Huons would re-apply for a HU024 trial, the official at Huons said nothing had been decided regarding HU024 development.