Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines
Abstract Introduction OBI-858 is a brand-new botulinum Type A complex toxin with a specific molecular weight of 760 kDa intended for development for both aesthetic and therapeutic applications. This is a phase I, dose-escalation study to evaluate the safety and preliminary efficacy of OBI-858 in sub...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2024-11-01
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| Series: | Dermatology and Therapy |
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| Online Access: | https://doi.org/10.1007/s13555-024-01309-7 |
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| author | Chih-Hung Lee Chien-Chih Ou Tim-Mo Chen |
| author_facet | Chih-Hung Lee Chien-Chih Ou Tim-Mo Chen |
| author_sort | Chih-Hung Lee |
| collection | DOAJ |
| description | Abstract Introduction OBI-858 is a brand-new botulinum Type A complex toxin with a specific molecular weight of 760 kDa intended for development for both aesthetic and therapeutic applications. This is a phase I, dose-escalation study to evaluate the safety and preliminary efficacy of OBI-858 in subjects with moderate to severe glabellar lines. Methods Each subject received OBI-858 by intramuscular injections with an assigned dose (10 U, 20 U, and 30 U). The safety and preliminary efficacy were evaluated at each of the in-person visits. Results A total of 36 subjects (12 subjects per cohort) were enrolled. The response rates (≥ 1 point) for all groups at maximum frown were assessed at week 4 were 100%. The initial improvement for 30 U occurred at day 3. Response rates revealed benefits lasting 4–6 months or longer. Subject satisfaction at week 4 was high in all groups. Adverse effects were mild and infrequent. Among them, one subject had drug-related AE, and one subject had grade ≥ 3 unrelated AE. Conclusions This study demonstrated that OBI-858 is well tolerated and showed preliminary efficacy. Overall, the OBI-858 has a clinically favorable profile of safety and efficacy that warrants proceeding to the next studies. |
| format | Article |
| id | doaj-art-919bcc2abb3849158c4e4cc9f430a502 |
| institution | OA Journals |
| issn | 2193-8210 2190-9172 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Dermatology and Therapy |
| spelling | doaj-art-919bcc2abb3849158c4e4cc9f430a5022025-08-20T02:08:15ZengAdis, Springer HealthcareDermatology and Therapy2193-82102190-91722024-11-0114123367337810.1007/s13555-024-01309-7Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar LinesChih-Hung Lee0Chien-Chih Ou1Tim-Mo Chen2Department of Dermatology, Kaohsiung Chang Gung Memorial Hospital, and Chang Gung University College of MedicineDepartment of Development Team, OBI PharmaDepartment of Surgery and Division of Plastic and Reconstructive Surgery, Tri-Service General Hospital, National Defense Medical CenterAbstract Introduction OBI-858 is a brand-new botulinum Type A complex toxin with a specific molecular weight of 760 kDa intended for development for both aesthetic and therapeutic applications. This is a phase I, dose-escalation study to evaluate the safety and preliminary efficacy of OBI-858 in subjects with moderate to severe glabellar lines. Methods Each subject received OBI-858 by intramuscular injections with an assigned dose (10 U, 20 U, and 30 U). The safety and preliminary efficacy were evaluated at each of the in-person visits. Results A total of 36 subjects (12 subjects per cohort) were enrolled. The response rates (≥ 1 point) for all groups at maximum frown were assessed at week 4 were 100%. The initial improvement for 30 U occurred at day 3. Response rates revealed benefits lasting 4–6 months or longer. Subject satisfaction at week 4 was high in all groups. Adverse effects were mild and infrequent. Among them, one subject had drug-related AE, and one subject had grade ≥ 3 unrelated AE. Conclusions This study demonstrated that OBI-858 is well tolerated and showed preliminary efficacy. Overall, the OBI-858 has a clinically favorable profile of safety and efficacy that warrants proceeding to the next studies.https://doi.org/10.1007/s13555-024-01309-7OBI-858Botulinum toxin aGlabellar lines |
| spellingShingle | Chih-Hung Lee Chien-Chih Ou Tim-Mo Chen Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines Dermatology and Therapy OBI-858 Botulinum toxin a Glabellar lines |
| title | Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines |
| title_full | Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines |
| title_fullStr | Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines |
| title_full_unstemmed | Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines |
| title_short | Phase I Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of OBI-858 for Treatment of Glabellar Lines |
| title_sort | phase i trial to assess the safety tolerability and preliminary efficacy of obi 858 for treatment of glabellar lines |
| topic | OBI-858 Botulinum toxin a Glabellar lines |
| url | https://doi.org/10.1007/s13555-024-01309-7 |
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