PharmAbcine, Inc. (“PharmAbcine” or the “Company”) (KOSDAQ: 208340), a clinical-stage public company focused on developing novel antibody therapies for patients, today announced that the Safety Review Committee (SRC) has approved advancing to dose level 2 of the PMC-403 Phase 1 clinical study in neovascular age-related macular degeneration patients following completion of dose level 1 safety data evaluation.
In this clinical study, a maximum of 36 patients with neovascular age-related macular degeneration with suboptimal response to currently available therapy will be evaluated for safety and maximum tolerated dose (MTD) of PMC-403. The SRC reviewed the clinical data for dose level 1, and all of the SRC members agreed to advance to the dose level 2.
The secondary endpoint for this clinical study is efficacy data which includes changes in best corrected visual acuity (BCVA), central retinal thickness, and intraocular fluid leakage. All of the patients who received the dose level 1 treatment of PMC-403 showed improvement in BVCA in the first month, suggesting the potential for promising efficacy data.
PMC-403 is an antibody therapeutic candidate with a novel mechanism of action in which it activates the TIE2 receptor and normalizes the leaky pathological blood vessels. PMC-403 offers a new treatment option for patients with unmet needs in vascular ophthalmic diseases who do not respond to current marketed treatments which target vascular endothelial growth factor (VEGF).
Dr. Jin-San Yoo, President and CEO of PharmAbcine, commented “As the safety of the starting dose of PMC-403 has been confirmed and the dose escalation has been approved, as well as improvements in the patients’ vision, PMC-403 will most likely be the new treatment option for age-related ophthalmic diseases. In addition, the MoA of PMC-403 has potential to treat various systemic vascular diseases which enables expansion of indications and maximizing the value of PMC-403.”
Age-related macular degeneration is a vision-threatening condition caused by abnormal blood vessels in the macula due to retinal aging. While the aging population has led to a significant increase in the number of patients, the current standard treatment, VEGF inhibitors, still show non-responders and do not guarantee optimal treatment. Therefore, there is a high demand for a new treatment option with novel MoA that can complement existing therapies.
According to the global market research agency Market Research Future (MRF), the global age-related macular degeneration market was estimated to be US$9.6 billion in 2021 and is expected to grow at an average annual rate of 8.09% (2018-2027), reaching US$15.3 billion in 2027.