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Huons Discontinues Development of Dry Eye Treatment After 10 Years of Effort

[비즈한국] It has been identified that Huons243070 has recently discontinued the development of a dry eye treatment and a peptic ulcer medication. Among them, the dry eye treatment was a product Huons had cherished since 2015, having pushed it through two Phase 3 clinical trials. Attention is now focused on how this will shift Huons' future strategy for developing new drugs and improved versions of existing ones.

According to the Financial Supervisory Service's Data Analysis, Retrieval and Transfer System (DART) on the 29th, Huons removed the dry eye treatment HUC2-007 from the list of R&D projects in its semi-annual report for this year. While it had been included in the R&D list up until the Q1 report, it was excluded starting from the semi-annual report.

HUC2-007 was an improved drug candidate that Huons had high expectations for, to the point that the company conducted two Phase 3 clinical trials. Although the first Phase 3 trial was completed in July 2020, it failed to obtain product approval. At the time, Huons applied for approval to the Ministry of Food and Drug Safety, but after receiving a request for supplementary data, the company voluntarily withdrew the application a year later.

After much deliberation, Huons proceeded with a second Phase 3 clinical trial, but the results were not satisfactory. In September last year, the results of the second Phase 3 trial for HUC2-007 were released; while it proved non-inferiority compared to the control group "Restasis Ophthalmic Solution," it failed to demonstrate superiority over another control group, "Moisview Ophthalmic Solution." When asked about the status of HUC2-007, a Huons official replied, "It is true that the project has been discontinued."

In the second quarter of this year, Huons also ceased development of HUC2-363, a treatment for peptic ulcers. This was an improved drug candidate that had been in development since February last year, with its status disclosed through the third-quarter report of that year. Regarding the reason for the discontinuation of HUC2-363, a Huons official stated, "We discontinued it due to fluctuations in the gastrointestinal drug market."

With this, most of Huons' current pipeline of new drug and improved drug candidates—with the exception of HUC3-637, which is being developed as a treatment for primary open-angle glaucoma or ocular hypertension—are in the early stages of clinical development. HUC3-637 received approval for its Phase 3 clinical trial plan (IND) from the Ministry of Food and Drug Safety last April. A Huons official said, "It is a product with improved application comfort compared to existing glaucoma treatments, and we plan to begin the Phase 3 trial within this year."

HUC1-394, the only dry eye treatment currently being developed as a new drug in the pipeline, is in Phase 1 clinical trials. The initial plan was to complete it within this month. Huons has decided to determine whether to proceed to Phase 2 clinical trials within the year.

HUC2-364, another candidate for a peptic ulcer treatment—the same indication as the discontinued HUC2-363—is also undergoing Phase 1 clinical trials. HUC2-364, a proton pump inhibitor (PPI), is an improved drug candidate that Huons is developing as a film-coated tablet to reduce the unpleasant smell and taste inherent in the original drug "Pariet" (generic name: rabeprazole). It received approval for its second Phase 1 clinical trial plan (IND) from the Ministry of Food and Drug Safety on September 4 last year, and it is expected to conclude next month.

Last year, rabeprazole recorded 202.2 billion KRW in outpatient prescription sales in the domestic peptic ulcer market, ranking second only to esomeprazole (288.9 billion KRW). Its advantage lies in its faster onset of action compared to other PPI agents, allowing for rapid suppression of stomach acid.

A Huons official stated, "We are developing not only the generics required by the market but also differentiated improved products through formulation research," adding, "We are expanding our new drug pipeline through open innovation and strengthening our internal research capabilities."