OBIGEN PHARMA, Inc. (hereinafter referred to as "OBIGEN") announced today (3/20) that the interim analysis of its OBI-858 novel botulinum toxin in the "Dose-ranging Phase 2 Clinical Trial" has shown that the product successfully met the efficacy and safety objectives for the treatment of moderate to severe glabellar lines. The analysis also received a positive response from the Data and Safety Monitoring Board (DSMB), which recommended the 20-unit dose for Phase 3 clinical trials.

OBI-858 is a new botulinum toxin independently developed by OBIGEN, designed for both aesthetic and medical indications. It has received patents in multiple countries, including Taiwan, Australia, New Zealand, Japan, Russia, Saudi Arabia, Indonesia, Malaysia, and Singapore. This new botulinum toxin utilizes a proprietary bacterial strain developed by OBIGEN, featuring innovative molecular weight and formulation design.

The interim analysis of the second part of the ongoing Phase 2 clinical trial for OBI-858 aimed to evaluate the efficacy and safety of the 10-unit and 20-unit dose groups in treating moderate to severe glabellar lines. The analysis results showed that both the 10-unit and 20-unit dose groups demonstrated significant improvements in glabellar line treatment by Day 29. This was assessed using the Glabellar Lines Severity Scale, the Global Aesthetic Improvement Scale (GAIS), and self-assessments of treatment satisfaction, all showing statistically significant differences compared to the placebo group (10U, p< 0.001; 20U, p< 0.001).

In terms of safety, the trial results showed that both the 10-unit and 20-unit dose groups had excellent safety profiles, with no detection of antibodies against OBI-858 after treatment, indicating good tolerability.

Based on the recommended dosage from the DSMB, OBIGEN will proceed to the next stage of the Phase 3 clinical trial, increasing the sample size to further verify the efficacy and safety of OBI-858. The Phase 3 trial is expected to be completed in 2026.

The complete data from this Phase 2 clinical trial will be made available after the trial unblinding, and will be presented in a future conference, where detailed efficacy and safety data for OBI-858 will be shared.

Dr. Heidi Wang, Chairperson of OBIGEN, stated, "We are thrilled with the performance of OBI-858 in clinical trials. The interim analysis results not only show excellent safety but also confirm its outstanding efficacy. We are confident in OBI-858’s performance in the upcoming Phase 3 trials, and we will continue our efforts to bring this innovative product to market, benefiting global aesthetic consumers and medical patients, helping people pursue health and beauty."

According to a report from Research And Markets, the global botulinum toxin market sales are estimated to grow from USD 7.48 billion in 2024 to USD 8.12 billion in 2025, and are expected to reach USD 12.41 billion by 2030, with a compound annual growth rate (CAGR) of 8.8%. With the global aging population and increasing emphasis on beauty, consumer demand for botulinum toxin in aesthetic and medical applications is rapidly growing. OBIGEN’s OBI-858 new botulinum toxin is well-positioned to play an important role in this expanding market.

About OBIGEN

OBIGEN PHARMA, Inc. focuses on the research, development, and production of new drugs. It is the first Taiwanese startup company to research, develop, and manufacture botulinum toxin products. With its core research and production capabilities in botulinum toxin products, OBIGEN is injecting new vitality into the medical industry.

Contact Information:

Contact: Anais Chen
Phone: +886-2-2786-1217
Email: contactus@obigenpharma.com
Website: https://www.obigenpharma.com