The top priority this year is the technology export of the atopic dermatitis treatment 'Nugel.'
Seong Seung-yong, CEO of Shaperon, noted in a meeting with ChosunBiz on the 21st of last month, "Recently, through Phase 2 Part 1 clinical trials in the U.S., we have proven the excellent safety and efficacy of Nugel in patients with mild to moderate atopic dermatitis, and based on this, we are discussing with several global pharmaceutical companies." Shaperon is a company established in 2008 as an on-campus venture by Professor Seong Seung-yong from Seoul National University College of Medicine and was listed on the KOSDAQ in October 2022.
Atopic dermatitis is a representative chronic inflammatory skin disease. The main causes are immune hypersensitivity and impaired skin barrier function. About 60% of atopic dermatitis patients are under 15 years old, and existing treatments all have risks of side effects, making continued use difficult.
Nugel is an anti-inflammatory agent that targets GPCR19, which exists only in immune cells. It regulates the inflammatory response caused by excessive immune cell activity fundamentally, resulting in fewer side effects, according to CEO Seong.
According to Shaperon, Nugel has demonstrated therapeutic efficacy in Phase 2b Part 1 clinical trials involving 33 patients in the U.S. The 'EASI 50' index, which evaluates the effectiveness of atopic dermatitis treatment, refers to the percentage of patients showing over 50% improvement compared to right before dosing. In the clinical trial, patients on placebo showed an EASI 50 of 44.4%, while the Nugel 0.5% dosing group recorded 80%, the Nugel 1% group reached 100%, and the Nugel 2% group had 83.3%.
The clinical trial results for Nugel surpass those of competing drugs. Jakavi from Insight in the U.S. showed an EASI 50 figure of 78.8% in its Phase 3 trial. Pfizer's Eucrisa registered 68.8%, and Acuris' Zolireb showed 69.2%. Otsuka's Moisturizer in Japan only reached 58.24%.
CEO Seong stated, "After completing Phase 2b Part 1 in the U.S. last year, we are currently preparing to enter Part 2," adding that "patient enrollment in U.S. institutions will begin in March." Phase 2b Part 2 will see significant expansions in the U.S. and Korea. A total of 12 institutions, including four new U.S. sites and four institutions in Korea, will conduct trials involving 177 patients.
In 2004, while a professor at Seoul National University, CEO Seong first published the theory that "the increase of molecular waste in the human body causes inflammation" in the international journal "Nature Reviews Immunology." Based on this theory that substances controlling molecular waste in the human body can suppress inflammation, he developed Nugel after 20 years of research.
However, commercialization is not easy. The rising interest rates, poor domestic stock market, and tightening funding markets made 2023 and 2024 particularly tough for domestic bio corporations. To obtain funding for Nugel's U.S. Phase 2b research, Shaperon conducted a capital increase for the first time since its listing last June, but it did not secure the target amount.
The process of developing new drugs takes an average of 10 to 15 years, from candidate discovery to FDA approval, with an expense of $800 million (about 1.1 trillion won). Given the enormous costs involved, domestic corporations are pursuing strategies to transfer technology to global pharmaceutical companies for commercialization. Shaperon is no exception.
CEO Seong mentioned, "We held follow-up meetings with companies with whom we signed non-disclosure agreements at the JP Morgan Healthcare Conference last January," adding that "we are advancing negotiations for technology transfer with 11 global pharmaceutical companies, including leading multinational firms in the dermatology institutional sector, and currently conducting technical due diligence with some of them."
Shaperon aims to achieve concrete business results, including technology transfer, within the year. CEO Seong expressed, "Once the results of Part 2 are out, the pace of negotiations with global corporations will accelerate," stating, "If Nugel is successfully launched, it could change the paradigm of atopic treatment."
CEO Seong said he aims to create a virtuous cycle by securing funds needed for the development of other treatments through the transfer of Nugel technology. Shaperon has also started developing new drugs in various treatment areas such as hair loss and anti-aging. The company built an artificial intelligence (AI) based new drug development platform last year. AI collects and learns data on the structures and biological activity of nearly 240 million low molecular weight compounds and proteins, enabling the discovery of candidate substances.
CEO Seong noted, "Recently, we succeeded in developing new compounds that target specific proteins using AI," highlighting that "they exhibited over 100 times higher efficacy than competing substances of the same category." He also mentioned that this substance has shown excellent effects in treating alopecia areata among various indications and is currently under development as a treatment. CEO Seong stated, "We plan to strengthen research on alopecia areata, metabolic disorders, age-related diseases, and create additional opportunities for technology transfer."