PharmAbcine Announces Safety Approval for 4mg Single-dose Cohort in Phase 1 Clinical Trial of PMC-403 for Neovascular Age-related Macular Degeneration
Overview
PharmAbcine, Inc. (KOSDAQ: 208340), a clinical-stage public company developing next-generation therapeutics to address unmet medical needs, today announced that its TIE2-activating antibody candidate, PMC-403, has received unanimous safety approval from the Safety Review Committee (SRC) for the 4mg single ascending dose (SAD) cohort in its Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD). The Company is now preparing to begin enrollment for the 4mg multiple ascending dose (MAD) cohort.
About the PMC-403
- PMC-403 is a novel TIE2-activating antibody with a unique mechanism that stabilizes pathological, leaky blood vessels.
- TIE2 receptors, expressed on endothelial cells, play a critical role in vessel normalization processes such as angiogenesis and intercellular adhesion, thereby inhibiting the progression of AMD.
Phase I target
- This Phase 1 trial targets patients with neovascular AMD who no longer respond to anti-VEGF standard therapies.
- The safety and tolerability of the 4mg single dose were successfully confirmed, laying the groundwork for advancing to the multiple-dosing phase.
Words from the CTO: PharmAbcine
Dr. Weon Sup Lee, Head of R&D and Chief Technology Officer at PharmAbcine, stated, ""The successful completion of the 4mg single-dose study is a significant milestone, highlighting the potential of PMC-403 as a breakthrough treatment for AMD. As we move forward with the multiple-dose study, we aim to gather additional safety and efficacy data to establish a robust foundation for Phase 2 trials.""
About Macular degeneration
- Macular degeneration, a leading cause of blindness, results from aging-related damage to the retina, particularly due to the development of abnormal blood vessels in the macula.
- The global aging population has led to a rapid increase in cases, and current treatments with anti-VEGF inhibitors are often insufficient for complete treatment.
- Consequently, there is a growing demand for therapies with novel mechanisms of action.
For phase II trial
- PharmAbcine plans to continue its research with the goal of initiating a Phase 2 trial after confirming the safety and efficacy of the 4mg multiple-dose cohort.
- The Company expects PMC-403 to play a pivotal role in the global market for AMD treatments.
PMC-403: study in diff therapeutic areas
- Beyond ophthalmology, PMC-403 is being explored in therapeutic areas, including vascular-related rare diseases, Acute Respiratory Distress Syndrome, Inflammatory Bowel Disease, Duchenne Muscular Dystrophy, Traumatic Spinal Cord Injury, oncology and kidney diseases.
- The Company has collaborated with Dr. Kirk Druey, former Chief of the NIH's Lung and Vascular Inflammation Section, to explore PMC-403's efficacy in animal models for Systemic Capillary Leak Syndrome (SCLS, also known as Clarkson disease).
- In a recent interview, Dr. Druey expressed excitement about PMC-403's potential in treating SCLS patients.
- While there is currently no approved treatment for SCLS, PMC-403 received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of SCLS on February 21, 2023.
Further info: -
- For more information about the Phase 1 clinical trial for neovascular age-related macular degeneration (nAMD), please visit (https://clinicaltrials.gov/study/NCT05953012).
- For more information about PMC-403 in SCLS, please visit Dr. Druey's interview on the NIH ""I am Intramural"" blog (https://irp.nih.gov/blog/post/2024/03/experimental-antibody-tightens-up-leaky-blood-vessels).
About PharmAbcine Inc.
- PharmAbcine is a clinical-stage public company developing next-generation IgG-based therapeutics to treat cancer, neovascular eye diseases, and unmet vascular-related needs.
- The Company's main pipeline includes clinical assets olinvacimab, PMC-403, and PMC-309.
Olinvacimab, the Company's lead asset, is undergoing a Phase II trial in combination with MSD's pembrolizumab for mTNBC patients in Australia to reconfirm the encouraging results from a Phase Ib olinvacimab plus pembrolizumab trial, which delivered 50% ORR, 67% DCR, and a clean safety profile.
About PMC-403
- PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional, leaky, and disorganized pathological vessels.
- It is being tested for neovascular AMD in Phase 1 trials in Korea.
- PMC-403 is also being explored in other therapeutic areas related to pathological blood vessels, including rare and non-rare vascular-related diseases.
