Consistent Efficacy Demonstrated Across Four Major Autoimmune Diseases:
Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis, and Crohn's Disease
Hyundai ADM Bio, together with its parent company Hyundai Bioscience, announced on the company's website on October 24 the interim preclinical research results for Penetrium in autoimmune diseases, which were presented at the ongoing 'AACR-NCI-EORTC 2025' international conference in Boston, USA. The AACR-NCI-EORTC is a global academic conference jointly hosted by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC).
This latest result follows the previously released research on rheumatoid arthritis and multiple sclerosis, which was made public at the Seoul Press Center on October 14, and includes additional studies on psoriasis and Crohn's disease. It marks the first case in which consistent efficacy was reproduced across all four major diseases using the same drug, dosage, and administration method.
Hyundai ADM and Hyundai Bioscience have selected four diseases-rheumatoid arthritis (joints), multiple sclerosis (nerves), psoriasis (skin), and Crohn's disease (digestive organs)-as initial development targets, based on criteria such as ease of entry into global clinical trials, market size, and fast-track suitability, representing the overall pathological and industrial structure of the autoimmune disease market, which includes over 200 systemic autoimmune diseases.
By reproducing consistent efficacy across these four disease groups with the same drug, dosage, and administration method, the companies have demonstrated the industrial potential of treating all autoimmune diseases through a single mechanism. This suggests the possibility of shifting from the traditional paradigm of developing treatments for individual diseases in parallel to a platform-based revenue model encompassing multiple diseases through a unified mechanism.
Penetrium does not suppress the immune response of cells. Instead, it restores the pathological stiffness of the extracellular matrix (ECM) and tissue microenvironment (TME), guiding cells and the immune system to regain their original order.
According to the research results, psoriasis showed a 33.6% reduction in PASI (Psoriasis Area and Severity Index), and when combined with the standard treatment (Methotrexate), Penetrium demonstrated 1.66 times the efficacy compared to Methotrexate alone. In Crohn's disease, there was a 47.0% reduction in DAI (Disease Activity Index), and when combined with the standard treatment (Prednisolone), Penetrium showed 2.13 times the improvement compared to Prednisolone alone. For rheumatoid arthritis, when combined with the standard treatment (Methotrexate), complete remission was observed in 4 out of 6 subjects after 9 days of administration. In multiple sclerosis, when combined with the standard treatment (Ozanimod), the recovery rate of motor function improved by 62.0% compared to the untreated group.
This research experimentally demonstrates that the cause of autoimmune diseases is not immune overactivity, but rather pathological changes in the ECM and TME-so-called 'pseudo-resistance.' Penetrium's consistent efficacy with the same dosage and administration method confirms its structural potential as a multi-disease treatment based on a single mechanism.
As of 2024, the autoimmune disease therapeutics market is valued at approximately 120 billion dollars, with an average annual growth rate of 3-7%. It is considered the second-largest global therapeutic sector after oncology.
Most existing treatments are immunosuppressants, which carry high risks of infection and relapse with long-term use, leading to increasing industrial demand for 'non-immunosuppressive alternatives.'
Penetrium, with its three key strengths-non-immunosuppressive, oral administration, and multi-disease applicability-has the potential to shift the treatment paradigm in the autoimmune disease therapeutics market from suppression-focused to restoration-focused approaches.
Hyundai ADM explained that Penetrium is evaluated as having an Expandable Indication Platform structure, enabling early entry into the multi-disease market through joint development and global licensing. This signifies the emergence of a platform-type blockbuster drug capable of restructuring the industry itself, rather than being a new drug for a single disease.
This research is the first to demonstrate that the ECM and TME restoration mechanism, previously confirmed in cancer treatment, also operates in autoimmune diseases. It also confirms that 'pseudo-resistance,' a major cause of cancer treatment failure, is a common pathological phenomenon in autoimmune diseases.
With cancer and autoimmune diseases now redefined as disease groups existing on the same structural pathological axis, Penetrium is being evaluated as the first therapeutic agent capable of integrating cancer, autoimmune, and neurological diseases into a single pathological platform.
Penetrium is an oral formulation based on niclosamide, with a 4.3-fold improvement in absorption compared to conventional niclosamide. Its safety has already been demonstrated in phase 2/3 clinical trials for COVID-19. As a result, for autoimmune disease indications, it is eligible to proceed directly to phase 2 clinical trials without phase 1.
This interim research result is described as 'the first experimental case to open the path for treating systemic autoimmune diseases with a single drug' and is expected to serve as a turning point that fundamentally transforms the global therapeutic industry structure and revenue models, beyond mere medical innovation.
Cho Wondong, Chairman of Hyundai ADM, stated, "Together with Hyundai Bioscience, we are pursuing applications for Fast Track and Breakthrough Therapy designations with the US FDA," adding, "We also plan to concurrently pursue joint development and licensing partnerships with global pharmaceutical companies."
He further stated, "Going forward, we aim to develop into a 'cell microenvironment restoration therapy' (MERT) platform company through Penetrium."
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