1.Date of occurrence of the event:2021/11/30
2.New drug name or code:Novel Botulinum Neurotoxin, OBI-858
3.Indication:OBI-858, an in-house developed new botulinum neurotoxin (BoNT) product, is planned for aesthetic and therapeutic uses. BoNT is a protein neurotoxin produced by the bacterium, Clostridium botulinum, during the process of reproduction. It consists of a complex mixture of proteins containing 150-kDa protein toxins organized into 100 kDa heavy chain and 50 kDa light chain, which are linked by disulfide bond as well as several other nontoxic accessory proteins that varies the molecular weight from 300 to 900 kDa. OBI-858 is a special 760 kDa molecular weight BoNT containing active 150 kDa core neurotoxin protein. Patents for the above-mentioned special molecular weight have been granted in Taiwan and filed for application internationally. BoNT induces muscle paralysis and has been used for indications in areas such as neurology, gastroenterology, otolaryngology, dermatology, and especially in aesthetic applications. It is known that BoNT is FDA-approved for more than 10 therapeutic indications.
4.Planned development stages:Phase I, II, III clinical trial, and Biologics License Application (BLA)
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials (include interim analysis):
(A) Study design
a. Study: OBI-858-001
b. Objectives: to investigate the safety, tolerability, and preliminary efficacy of OBI-858 as treatment for subjects with moderate to severe glabellar lines.
c. Phase: Phase 1 dose escalation
d. Name of product: OBI-858
e. Indication: moderate to severe glabellar lines
f. Patient number: 36 subjects enrolled for dose escalation
(B) Study Evaluation and Results: OBI-858-001 is a Phase I, single treatment, open-label, Dose Escalation Study to evaluate the safety, tolerability and preliminary efficacy as treatment for subjects with moderate to severe glabellar lines. 36 subjects in 3 dose cohorts (12 subjects in each of the 10U/20U/30U cohorts) were successfully enrolled. There are no safety or tolerability concerns for above-mentioned 3 dose levels. Regarding preliminary efficacy, data revealed that the severity of glabellar lines at maximum frown, whether assessed by the investigators or subject themselves, demonstrated a significant decrease after OBI-858 injections. The results provide support for the implementation of Phase II Clinical Trial in the future.
(C) If it is a Phase 3 clinical trial result, brief the marketing plan: Not applicable
(D) Single clinical trial result may not accurately reflect the possibility of drug commercialization. Investors shall make prudent judgments and investments.
(2) Once disapproved by competent authority or each of clinical trials (include interim analysis) results less than statistically significant sense, the risks & the associated measures the Company may occur: Not applicable
(3) After obtaining official approval or the results of statistically significant sense, the future strategy: proceed to Phase II clinical trial.
(4) Accumulated investment expenditure incurred: As the information is privileged to future negotiation of licensing deals, to avoid influence on licensing deals and for best interest of shareholders, it will be kept confidential temporary.
6.Upcoming development plan:
(1) Estimated date of completion: Expected to evaluate primary endpoint in 2024, actual schedule will be adjusted according to the patient enrollment and completion of therapy timeline.
(2) Estimated responsibilities: None
7.Market situation: According to Global Market Insights, the aesthetic and therapeutic markets for Botulinum Toxin products are about US$4.7 billion in 2018. The Compound Annual Growth Rate (CAGR) is expected to be 9.1%, and the global market is expected to be US$8.5 billion by 2025. At the moment, about 8-9 competitors have entered the market. The novel botulinum toxin,
OBI-858, is expected to be used in therapeutic and aesthetic indications.
8.Any other matters that need to be specified: None
9.New drug development requires long process, vast investments and with no guarantee in success which may pose investment risks.The investors are advised to exercise caution and conduct thorough evaluation.