The primary safety endpoint evaluation of the Phase I dose-escalation clinical trial for the novel botulinum toxin product OBI-858 has been completed, and a Phase II clinical trial is planned.
Name or Code of the Investigational New Drug
Novel Botulinum Toxin Product OBI-858
Intended Use
This product is a novel botulinum toxin formulation manufactured using a proprietary bacterial strain developed in-house and is intended for both medical and aesthetic applications.
Botulinum toxin is a neurotoxin protein produced during the growth of Clostridium botulinum. Its primary active component is a 150 kDa protein consisting of a 100 kDa heavy chain and a 50 kDa light chain linked by a disulfide bond. Additional components include non-toxic proteins and serum proteins. The active and accessory proteins may form protein complexes with molecular weights of approximately 300, 500, or 900 kDa.
OBI-858 is a unique botulinum toxin protein complex with a molecular weight of 760 kDa and contains the 150 kDa active neurotoxin protein. The unique molecular structure generated from the Company's proprietary bacterial strain has been granted patent protection in Taiwan, and international patent applications are planned.
Botulinum toxin causes temporary muscle paralysis and has applications in neurology, gastroenterology, otolaryngology, dermatology, and other medical fields. It is also widely recognized for its aesthetic and plastic surgery uses. Any condition involving excessive muscle contraction may potentially be treated with botulinum toxin. More than dozens of therapeutic indications have already been approved by the U.S. Food and Drug Administration (FDA).
Clinical Trial Information
https://www1.cde.org.tw/ct_taiwan/search_case2.php?caseno_ind%5B1%5D=6260
Planned Development Stages
．Phase I Clinical Trial
．Phase II Clinical Trial
．Phase III Clinical Trial
．New Drug Application (NDA) Review and Approval
Current Development Stage
Results of Human Clinical Trials or Other Material Events Affecting Drug Development
Clinical Trial Design
Study Protocol
OBI-858-001
Objectives and Endpoints
The primary objective of this Phase I dose-escalation study was to evaluate the safety and tolerability of OBI-858 in subjects with moderate to severe glabellar lines. The dose range evaluated was from 10 U to 30 U.
Clinical Phase
Phase I Dose-Escalation Clinical Trial
Investigational Product
Novel Botulinum Toxin Product OBI-858
Proposed Indication
Moderate to Severe Glabellar Lines
Number of Subjects
A total of 36 subjects were enrolled in the dose-escalation study.
Primary Endpoint Results
The OBI-858-001 study was a Phase I, single-treatment, open-label, dose-escalation trial designed to evaluate the safety, tolerability, and preliminary efficacy of OBI-858 in subjects with moderate to severe glabellar lines.
Safety evaluations have been completed for all 36 participants across the three dose cohorts of 10 U, 20 U, and 30 U.
The study results demonstrated favorable safety and tolerability profiles for all three dose levels. Regarding preliminary efficacy, improvements in glabellar line severity were observed across all dose groups following treatment, based on assessments conducted by both investigators and study participants.
The safety and preliminary efficacy data support proceeding to a Phase II clinical trial with an expanded sample size.
Commercialization Plan Following Phase III Clinical Results
Not applicable.
Investor Reminder
A single clinical study result is insufficient to fully predict the success or failure of future drug development and commercialization. Investors are advised to exercise caution and make prudent investment decisions.
Risks and Mitigation Measures
Not applicable.
Future Business Direction
The Company will proceed with the originally planned Phase II clinical trial.
Cumulative R&D Expenses
As disclosure of cumulative research and development expenses may affect future international licensing negotiations and potentially impact licensing values, such information is not disclosed at this time in order to protect shareholders' interests.
Next Development Stage
Expected Completion Timeline
The Phase II clinical trial is expected to be completed in 2024. However, the actual timeline may be adjusted depending on the progress of the study.
Expected Obligations
None.
Market Status
According to Global Market Insights, global sales of botulinum toxin products in both aesthetic and therapeutic markets reached USD 4.7 billion in 2018. The market is expected to grow at a compound annual growth rate (CAGR) of 9.1% from 2019 through 2025, reaching an estimated USD 8.5 billion by 2025.
Currently, approximately eight to nine competitors have entered the market. OBI-858 is intended for both therapeutic and aesthetic applications.
Other Matters Requiring Disclosure
None.
Cautionary Statement
Drug development requires substantial investment of time and resources and does not guarantee success. Such uncertainties may expose investors to significant risks. Investors are advised to carefully evaluate all relevant factors and exercise prudent judgment when making investment decisions.