HLB Therapeutics CEO Interview
Targeting Neurotrophic Keratitis 'RGN-259'
Plans to Complete Phase 3 Clinical Trial Within the Year
Brain Cancer Drug 'OKN-007' Also in Final Stage of Phase 2
[Asia Economy Reporter Chunhee Lee] "Ophthalmic diseases still represent a market with significant unmet needs. We plan to complete the Phase 3 clinical trial of 'RGN-259' within this year and deliver results soon."
On the 14th, An Ki-hong, CEO of HLB Therapeutics, who met with Asia Economy, expressed confidence that the company would soon achieve results with its pipeline drugs: RGN-259 for ophthalmic diseases and 'OKN-007', targeting glioblastoma, a type of brain cancer.
Among these, RGN-259 is conducting clinical trials for two indications: neurotrophic keratitis (NK) and dry eye disease (DED). Of the two, clinical progress is faster for NK. Phase 3 trials are currently underway simultaneously in the United States and Europe with a slight time difference. CEO An explained, "New drug approvals for ophthalmic diseases require verification of repeated treatment effects," adding, "We started first in the U.S. and plan to complete dosing within this year." Currently, 'Oxervate' is the only FDA-approved treatment in the U.S., but due to its high price and limited dosing convenience, the company aims to improve dosing convenience by reducing the dosing period to two weeks as a strategic move.
For dry eye disease, preparations are underway for the fourth Phase 3 clinical trial. The previous three Phase 3 trials failed to meet the primary efficacy endpoint. CEO An repeatedly emphasized that this is an unavoidable aspect of the nature of ophthalmic diseases rather than the efficacy of the candidate drug. He said, "Clinical trials for ophthalmic diseases are inherently difficult because signs, symptoms, and effects must all align one-to-one," and added, "Based on lessons learned from previous trials, we will thoroughly verify the clinical plan in advance through the FDA's Special Protocol Assessment (SPA) to ensure no failures and enter clinical trials within this year."
For OKN-007, a glioblastoma treatment, the plan is to increase the likelihood of success by combining various clinical trials. The company has completed dosing for a Phase 2 trial targeting patients with recurrence after surgery. In addition, they are conducting a Phase 1 trial for early-stage patients with an oral formulation designed to improve dosing convenience and enable combination therapy, aiming to enhance the value of the new drug.
There are also plans to expand the pipeline aligned with the company's identity as a developer of biologic new drugs. CEO An stated, "We plan to expand our pipeline into advanced new drug development fields, including investing in Immunomic Therapeutics, HLB's U.S. affiliate specializing in cancer treatment vaccines," and added, "In the long term, we also plan to move into the gene therapy field."
Regarding the synergy from being incorporated into the HLB Group, CEO An cited "ecosystem entry" as the greatest strength. He explained that within the framework called the 'HLB Eco-Bio System (HBS)', a well-formed structure exists where affiliates support each other. Although some critics call this an "octopus-like expansion," he emphasized, "Developing various pipelines simultaneously is necessary, but it would be burdensome for one company to handle everything alone," and added, "HLB, HLB Life Science, HLB Pharmaceutical, and HLB Therapeutics have created an ecosystem where each helps with what they do best."
The financial structure, which was previously manufacturing-centered with pump production accounting for 70% of sales during the GtreeBNT era, is gradually shifting. Thanks to the acquisition of YSP Pharm and entry into the vaccine distribution business, including being solely selected as the distributor for the national public COVID-19 vaccine this year, related sales have shown continuous growth. CEO An said, "We are transforming into a definitive bio-medical device company," and added, "While maintaining pump sales, we are steadily increasing bio-related sales such as vaccine distribution, changing the sales composition. We expect that sales from vaccine distribution and bio-medical device manufacturing will exceed 70% this year."
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