[MIK Hot Spot_KHIDI] Eye Bio Korea developing eye drop-type macular degeneration treatment made with new peptide
2020-04-29, Jane Lee Reporter
Eye Bio Korea participated in the MIK Hot Spot (Made in Korea Online Exhibition) KHIDI and introduced its macular degeneration treatment drugs with high hopes of meeting buyers and investors.
Q. Market situation (problems and limitations) at the time of starting the business and how it started (solutions)
Macular degeneration is a disease in which the macula, the nerve tissue in the center of the retina that plays an important role in vision, weakens due to aging and inflammation. It is characterized by angiogenesis in the eyeballs in the case of exudative macular degeneration, and is a major cause of blindness due to a sharp decrease in vision.
Currently in Korea, the elderly take up more than 10%, and by 2026, Korea will be entering the post-aged society. So, Korea needs to prepare well for elderly diseases such as macular degeneration. In fact, between 2011 and 2015, the number of people with macular degeneration increased by about 49%, and one in 100 people aged 65 or older suffer from macular degeneration. The most effective treatment currently known is an injection of an inhibitor of VEGF, the cause of angiogenesis, directly into the eye. This injection is given for quite a long time, and in some cases, it may require lifelong treatment. But, this treatment is very expensive (about 1 million won per time), and the insurance benefits is limited, so the patients often give up on the treatment due to the burden on the patient's medical expenses. In addition, the intraocular injection method is often repulsive to patients and many patients do not respond to this drug, so it is urgent to develop alternative drugs.
To replace the existing treatment for macular degeneration, we really needed to develop an inexpensive domestic treatment. In addition, we started the research on wet macular degeneration treatment using bio-friendly peptides with the idea that the existing treatments should be applicable to patients with resistance and improvement in the method of drug administration is needed. Peptides are the smallest unit of protein function that can have a strong effect even in small amounts and are very unlikely to cause toxicity in the human body. Also, it is expected to reduce the burden on patients by developing in the eye drop formulation for convenient administration.
Q. Product Introduction (Usage)
We are developing eye drop-type macular degeneration treatment made with new peptide. The synthetic peptide under development is a 7-mer size which is small in size and easy to synthesize, making it outstanding in production. It has gone through prior researched by synthesizing in the same injection-type that is currently out in the market, and the effect of suppressing inflammation and angiogenesis has been confirmed.
To alleviate the patient's objection to the injection procedure and increase the convenience of administration, we are currently changing the formulation to eye drop form, and the SMEDDS technology will be introduced here. When the SMEDDS technology is applied, the absorbancy in the eyeball tissue will increase and the permeability by per tissue will be improved to reach the effective concentration level of the drug to the eyeball tissue, so we are expecting to see the improvement in the bioavailability of the drug.
Q. Unique features and strengths of our product
Eye Bio's main pipeline is EB-201, which is being developed as a treatment for wet macular degeneration. It is a 7-mer sized synthetic peptide product that is excellent in terms of productivity and has excellent solubility and stability in physical properties as well.
Eye Bio Korea is developing a wet macular degeneration treatment using EB-201 as an eye drop by applying SMEDDS technology. Through this, we intend to overcome the shortcomings of intravitreal injection selected by existing wet macular degeneration treatments.
Eye Bio Korea's research results, EB-201 has been confirmed to exhibit treatment efficacy equal to or higher than that of existing anti-VEGF treatments, and is expected to replace existing treatments. Since it is a different inflammation targeting treatment agent from the previous one, it is seen possible to use together with anti-VEGF. Therefore, we can expect synergy from the wet macular degeneration with EB-201.
Q. Introduction of members (company credibility goes up due to related experience of major members)
I am the CEO of Eye Bio Korea, and also the supervising professor at the Class of Ophthalmology at Inje University Busan Paik Hospital. I am the head of many research centers. Our center was selected as ophthalmic disease T2B (Technology to Business) base implementation center by the Ministry of Health and Welfare (MOHW) in August 2015, and supports the initial non-clinical efficacy evaluation stage of new drugs and medical devices in the ophthalmology field. We have also been selected as the open lab implementation business center by the MOHW in March 2019, providing clinical linkages and brokerage research support to companies that need to start businesses and commercialize technologies. By using the 27 years of experience in clinical and basic medical research, we are in charge of presenting the direction of developing new drugs and designing clinical trials. We are about to acquire the AAALAC-I certification, expecting to grab more reliable results in the evaluation of the efficacy of new drug development.
Vice President Lim Hyung-jun is a veterinarian with over 15 years of experience in non-clinical research on ophthalmic diseases and the development of therapeutic agents for ophthalmic diseases with peptides. His roles in presenting the direction of non-clinical research development of the ophthalmic pipeline and reviewing the non-clinical research results are very important to our company.
The head of the research center Cho Yoon-seok is an ophthalmic drug development expert who served as the head of the research center at Hanlim Pharm, the number one company in the ophthalmic solvent market in Korea. With years of experience in developing ophthalmic solvents, he presents the direction for the research, and plays an important role in developing the treatment drugs that meet the needs of the pharmaceutical company.
Also, in Eye Bio Korea, there are many talented members optimized for the development of ophthalmic treatments drugs, from the directors who was a pharmacist with a lot of experience in pharmacokinetics research and a veterinarian who worked as a non-clinical research center head in a large pharmaceutical company in Korea to researchers with more than seven years of research experience in ophthalmic disease research.
Q. Future plans (global entry, new product launch, etc.)
Eye Bio Korea plans to receive IND approval for clinical phase 1 trial of wet macular degeneration treatment using EB-201 by the first half of 2022, and is planning for a license out or global clinical trials by joint research with multinational pharmaceutical companies.
The total amount of EB-201's technology export that we are thinking of is about $1 billion with the contract amount of about $30 million. The time point of license out we are planning is around the end of 2022 to early 2023.
For the successful implementation of technology development and export, Eye Bio Korea is trying to develop products that meet the needs of pharmaceutical companies based on continuous discussions with global pharmaceutical companies.
Q. Introduction of the programs supported by KHIDI's support programs
Currently, Eye Bio Korea has been selected by KHIDI for the 2019 Startup Leap Package Project and received approximately 1.3 billion won. Through this, we were able to recruit new research personnel, register intellectual property rights, receive technical evaluations, complete discovery studies of major pipelines, and enter the non-clinical research stage.
In particular, Eye Bio Korea applied to the bio-industry core technology development project of this year to conduct full-scale non-clinical research on pipelines that were discovered and improved through the Startup Leap Package Project. We were selected, and have received 4.2 billion won for five years as development cost.
Venture companies developing bio new drugs often face many economic difficulties until the initial investment is completed and the development gets on the track, and I think the Startup Leap Package Project is an important support program that can solve the dilemmas of such bio startups.
The products and services of the major companies of KHIDI Health Industry Startup Innovation Center in the MIK Hot Spot (Made in Korea Online Exhibition) will also be displayed in BIO KOREA 2020. Asia's biggest bio convention BIO KOREA 2020 co-organized by KHIDI and Chungbuk Province and sponsored by MOHW will be open online due to the COVID-29 pandemic on May 18-23. Virtual exhibition halls, conference, and business forums will be operated, and the companies will be promoting their competitiveness. Also, with video meetings, businesses between overseas speakers, buyers, and domestic and foreign participating companies will be made. To date, more than 160 companies have applied for the virtual exhibition booth at BIO KOREA 2020. Companies wishing to participate can apply through the web page or email by Apr. 30.
The global news network AVING News has begun holding the MIK Hot Spot (Made in Korea Online Exhibition) to help small and medium-sized companies enter the market and attract investment 365 days a year. AVING News has been running online exhibitions since 2005 and had 975 online exhibitions so far. Its YouTube online exhibition has placed itself as Korea's largest online exhibition hall that opens with 19,000 videos (booths) with more than 800,000 visits per month which means more than 10 million visits per year.
The MIK Hot Spot online exhibition is scheduled to be held regularly according to the field, target market, and participating institutions, and it will be presented as a new type of online business by transforming the know-hows and values of the participating companies according to the trend. Companies that want to participate can apply and apply through the marketing support projects from supporting institutions in the local governments. Refer to the institutions for more information.