(Health Korea News / Lee Si-woo) AngioLab announced on the 10th that the Ministry of Food and Drug Safety approved the phase 3 clinical trial plan (IND) for the company’s oral wet macular degeneration treatment candidate ‘ALS-L1023’.
AngioLab previously transferred ALS-L1023 technology to Sangmyung Innovation, a subsidiary of Hanlim Pharmaceutical, in November of last year. This clinical trial will be jointly conducted by Hanlim Pharmaceutical and Sangmyung Innovation in the future. The three companies are operating a joint research and development consultative body with the goal of obtaining approval for a treatment for wet macular degeneration.
Hanlim Pharmaceutical, specializing in ophthalmology, is a mid-sized pharmaceutical company that is developing and selling various treatments. Sangmyung Innovation, a subsidiary of Hanlim Pharmaceutical, plans to introduce technology and conduct clinical trials, and after the wet macular degeneration treatment is commercialized, Hanlim Pharmaceutical will be in charge of sales.
AngioLab will receive a technology transfer fee of KRW 11 billion, including a KRW 1 billion deposit, and a separate royalty based on sales through the technology transfer agreement. With the approval of the Phase 3 clinical trial IND, the KRW 1 billion deposit (upfront payment) received immediately after the technology transfer agreement can be recognized as revenue in accounting. If the first IRB approval is obtained, it is expected that an additional fixed technology fee will be received. This can be interpreted to mean that biotech companies that use technology transfer as their main revenue model are finally starting to generate revenue (accounting recognition) through technology transfer.
Anti-VEGF drugs currently used for macular degeneration, such as Lucentis, Eylea, and Bavismo, are all administered by direct injection into the eye, which has been criticized for causing inconvenience to patients, low administration convenience, high cost, and resistance issues due to long-term administration. ALS-L1023, which is a multi-target angiogenesis inhibitor with retinal pigment epithelial cell protection, is highly effective in improving vision even with a small number of intraocular injections when administered orally in combination with existing treatments.
In particular, AngioLab claimed that the proportion of patients who showed improvement in vision of 15 letters or more (3 lines on the ETDR visual acuity chart) was significantly higher than the control group in the phase 2 clinical trial. With this phase 3 IND approval, AngioLab plans to accelerate overseas technology transfer and apply for a technology assessment at an early date in order to challenge for a KOSDAQ listing next year.
AngioLab CEO Minyoung Kim said, “We are delighted that the IND for the phase 3 clinical trial of ALS-L1023, which we have been developing with great care for a long time, has been approved,” and added, “We will do our best to achieve good results in the phase 3 clinical trial to be conducted in cooperation with Hanlim Pharmaceutical and Sangmyung Innovation.”
Meanwhile, AngioLab’s R&D pipeline based on its core technology includes, in addition to wet macular degeneration treatment, metabolic-related fatty liver disease treatment, periodontal disease treatment, and exudative otitis media treatment. It has completed phase 2 or 2a clinical trials and is currently exploring technology transfer targets. Obex (lemon balm extract mixed powder), a health functional food for reducing visceral fat based on angiogenesis inhibition, has also been approved by the Ministry of Food and Drug Safety and is being sold domestically and internationally.
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