KOSDAQ-listed company Mediphron announced on the 13th that it has confirmed successful Phase 1 clinical trial results for ‘MDR-652,’ a non-opioid analgesic acting on neuropathic pain.
The company disclosed that it reviewed the key clinical trial details and the Clinical Study Report (CSR) with Hallym University Sacred Heart Hospital, the clinical trial institution for MDR-652.
Developed based on resiniferatoxin, a TRPV1 agonist significantly more potent than capsaicin, MDR-652 aims to suppress neuropathic pain such as diabetic neuropathy and postherpetic neuralgia, which do not respond to common anti-inflammatory analgesics.
In the form of a topical gel applied directly to the affected area, the primary objective of this Phase 1 clinical trial was to evaluate safety, tolerability, and systemic exposure after single or repeated application to the skin.
According to the report, MDR-652 showed no serious adverse reactions or significant changes in any subjects, and systemic exposure after single and repeated dosing was minimal, indicating excellent tolerability in the evaluation of local adverse reactions.
A Mediphron representative stated that to effectively advance MDR-652 toward new drug approval, the company is currently reviewing various future directions, including discussions with clinical contract organizations for Phase 2 trials and licensing-out opportunities with global pharmaceutical companies.
Meanwhile, Mediphron, a leading research company in the field of Alzheimer’s dementia treatment, is accelerating clinical research and drug development based on the beta-amyloid mechanism. The early dementia diagnostic kit, co-developed with in vitro diagnostics specialist Quantamatrix through a 2020 licensing-out agreement, is currently preparing for new medical technology registration following product certification from the Ministry of Food and Drug Safety.
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