760 kDa Botulinum Toxin Type A Candidate Demonstrates Favorable Tolerability, Rapid Onset of Treatment Response and Treatment Responses Observed Through Day 365
TAIPEI, Taiwan – September 8, 2026 — OBIGEN Pharma, Inc. (Taipei Exchange Emerging Market: 7876), a biopharmaceutical company focused on the development and manufacturing of botulinum toxin products, today announced results from its Taiwan TFDA-approved one-year, open-label, repeat-dose clinical study of OBI-858, the Company’s proprietary 760 kDa botulinum toxin type A drug candidate.
The study enrolled 200 participants, with 432 treatment exposures included in the safety analysis. OBI-858 was generally well tolerated following repeated administration, with treatment-related adverse events reported in 1.6% of treatment exposures. The study also generated supportive observations regarding the onset and persistence of treatment response.
Key Clinical Findings
● 200 participants enrolled in the one-year repeat-dose study
● Up to four 20 U treatment cycles permitted under the study protocol
● 432 treatment exposures included in the safety analysis
● 1.6% treatment-related adverse event rate per treatment exposure
● More than 50% of participants recorded an initial treatment response by Day 1, based on the study-defined Participant Glabellar Line Scale (GLS ≥1)
● Approximately 60% of participants received only one or two treatments during the one-year study period
● 20 participants who received only one treatment had a treatment response recorded at the Day 365 assessment
● No clinically meaningful impact of observed immunogenicity on treatment response or safety was identified during the one-year study period
Favorable Repeat-Dose Safety and Tolerability
The primary purpose of the one-year study was to evaluate the safety and tolerability of repeated administration of OBI-858.
Across 432 treatment exposures included in the safety analysis, treatment-related adverse events were reported in 1.6% of exposures. OBI-858 was generally well tolerated, and no new safety signal was identified during the repeat-treatment period.
Immunogenicity was also assessed during the study. No persistent immune response was observed, and no observed antibody response was associated with an apparent impact on treatment response or safety during the study period.
Supportive Observations Regarding Treatment Response
More than half of participants recorded an initial treatment response by Day 1, based on the study-defined Participant Glabellar Line Scale (GLS ≥1).
During the one-year follow-up period, approximately 60% of participants received only one or two treatments. Among the 20 participants who received only one treatment, a treatment response was recorded at the Day 365 assessment.
Because this was an open-label study without a concurrent control group and was designed primarily to evaluate safety and tolerability, these observations are considered supportive and exploratory and are not intended to establish comparative efficacy or a confirmed duration of effect.
Advancing OBI-858 Toward Regulatory and Global Development
OBI-858 is currently evaluated for the temporary improvement in the appearance of moderate to severe glabellar lines in a Taiwan Phase 3 clinical program. The Phase 3 program has completed last patient last visit (LPLV) following enrollment of approximately 600 participants. The Company is progressing toward database lock and planned unblinding of the Phase 3 results.
In parallel, OBIGEN Pharma is advancing plans for a U.S. Phase 2 clinical study of OBI-858 in glabellar lines, with the goal of generating additional controlled clinical data to support the Company’s international development strategy.
OBIGEN Pharma is also evaluating global licensing, regional distribution and strategic partnership opportunities for OBI-858.
A Proprietary 760 kDa Botulinum Toxin Type A Platform
OBI-858 is based on OBIGEN Pharma’s proprietary strain and manufacturing technology and incorporates a distinctive 760 kDa botulinum toxin type A complex. The Company’s technology has been granted patent protection in multiple markets, including the United States, Taiwan, Japan, South Korea, Australia, Mexico, Saudi Arabia, Indonesia, the Philippines, Vietnam, Malaysia and Singapore.
OBIGEN Pharma believes its proprietary platform, intellectual property and clinical development progress provide a foundation for further development of botulinum toxin type A products across potential aesthetic and therapeutic applications.
About OBIGEN Pharma, Inc.
OBIGEN Pharma, Inc. is a Taiwan-based biopharmaceutical company focused on the research, development and manufacturing of botulinum toxin products. The Company’s lead product candidate, OBI-858, is a proprietary botulinum toxin type A drug candidate featuring a distinctive 760 kDa complex protein structure. OBI-858 is formulated without animal-derived or alcohol-derived ingredients and has received Halal certification.
OBIGEN Pharma has established manufacturing facilities in the Hsinchu Biomedical Science Park and Tainan Science Park designed to comply with PIC/S GMP requirements, providing integrated capabilities spanning research and development, clinical development and commercial manufacturing. The Company is targeting completion of Phase 3 data unblinding by the end of 2026, submission of a Taiwan marketing authorization application in the first half of 2027 and potential commercial launch in Taiwan in 2028, subject to clinical results, regulatory review and approval. For more information, please visit www.obigenpharma.com.
Forward-Looking Statements
This press release contains forward-looking statements concerning OBI-858’s clinical development, potential regulatory submissions and approvals, future clinical studies, commercialization, market opportunities, licensing and strategic partnerships, manufacturing capabilities and anticipated development timelines.
These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Such risks include future clinical trial outcomes, regulatory review and approval, manufacturing and supply considerations, intellectual property protection, market acceptance, competition, pricing, changes in applicable laws and regulations, economic conditions and other factors beyond the Company’s control.
The supportive and exploratory observations described in this press release may not be predictive of results from future or controlled clinical studies. OBIGEN Pharma undertakes no obligation to update these forward-looking statements, except as required by applicable law.
Media and Investor Contacts
Patricia Chou
Spokesperson, OBIGEN Pharma, Inc.
Tel: +886-2-2786-1217
Email: contactus@obigenpharma.com