ABEONA THERAPEUTICS INC. (ABEO)
Abeona Therapeutics Inc. is a biopharmaceutical company in the clinical development stage, focused on creating innovative gene and cell therapies to address severe and uncommon genetic diseases. Its leading program, EB-101, an autologous gene-corrected cell therapy, is presently in a Phase III clinical trial for treating recessive dystrophic epidermolysis bullosa. The company's pipeline also features several other promising therapies: ABO-102, an adeno-associated virus (AAV)-based gene therapy for Sanfilippo syndrome type A. ABO-201, intended for CLN3 disease. ABO-401, developed to treat cystic fibrosis. ABO-50X, aimed at various genetic eye disorders. Additionally, Abeona is advancing AAV-based gene therapy solutions through its proprietary AIM vector platform. The company, which was founded in 1974 and is headquartered in New York, New York, changed its name to Abeona Therapeutics Inc. in June 2015, having previously been known as PlasmaTech Biopharmaceuticals, Inc.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Abeona Therapeutics Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Completed
A Study to Evaluate the Efficacy of MuGard for the Amelioration of Oral Mucositis in Head and Neck Cancer Patients
MuGard, Control Rinse
Oral Mucositis
NCT01283906Enrollment120StartJan 2011Primary CompletionApr 2013CompletionMay 2013 - Phase 4Not yet recruiting
Phase 4 Master Protocol for Patients Prescribed Prademagene Zamikeracel for the Treatment of Wounds
Non-conforming pz-cel surgical application to RDEB wounds, Pz-cel surgical application to DEB wounds
Epidermolysis Bullosa (EB), Recessive Dystrophic Epidermolysis Bullosa (RDEB) +1
NCT07717736Enrollment100StartNov 2026est.Primary CompletionNov 2031est.CompletionJul 2032est. - Phase 3Completed
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
ofloxacin, MSI-78
Diabetic Foot Ulcers
NCT00563394Enrollment584StartAug 1994Primary CompletionJul 1996CompletionJul 1996 - Phase 3Completed
MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers
ofloxacin, MSI-78
Diabetic Foot Ulcers
NCT00563433Enrollment342StartAug 1994Primary CompletionJul 1996CompletionJul 1996 - Phase 3Completed
Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB)
EB-101
Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa
NCT04227106Enrollment11StartJan 2020Primary CompletionOct 2022CompletionOct 2022 - Phase 3Active, not recruiting
A Phase 3b Study for the Treatment of Dystrophic Epidermolysis Bullosa (DEB) in New and Previously EB-101 Treated Patients
EB-101 Surgical application of RDEB wounds
Epidermolysis Bullosa, Recessive Dystrophic Epidermolysis Bullosa +1
NCT05725018Enrollment12StartApr 2023Primary CompletionSep 2025est.CompletionSep 2025est. - Phase 2Completed
A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail
EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)
Onychomycosis
NCT00385502Enrollment40StartSep 2006Primary CompletionJun 2008CompletionJun 2008 - Phase 2Completed
Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
amlexanox, Vehicle rinse
Oral Mucositis
NCT01083875Enrollment58StartFeb 2000Primary Completion-CompletionJun 2001 - Phase 1/2Completed
Gene Transfer for Recessive Dystrophic Epidermolysis Bullosa
LZRSE-Col7A1 Engineered Autologous Epidermal Sheets
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa
NCT01263379Enrollment12StartOct 2010Primary CompletionMar 2022CompletionMar 2022 - Phase 1/2Terminated
Gene Transfer Clinical Trial for Mucopolysaccharidosis (MPS) IIIB
rAAV9.CMV.hNAGLU
Mucopolysaccharidosis Type 3 B
NCT03315182Enrollment11StartOct 2017Primary CompletionApr 2022CompletionApr 2022 - ObservationalTerminated
A Long-term Follow-up Study of Patients With MPS IIIB Treated With ABO-101
ABO-101
Mucopolysaccharidosis III-B
NCT04655911Enrollment1StartOct 2020Primary CompletionApr 2022CompletionApr 2022 - ObservationalEnrolling by invitation
A Long-Term Extension Study for Participants Previously Treated With EB-101 for the Treatment of RDEB
EB-101
RDEB
NCT05708677Enrollment22StartFeb 2021Primary CompletionFeb 2036est.CompletionAug 2036est. - ObservationalRecruiting
A Long-Term Safety Follow-up Registry for Patients Who Received Treatment With Prademagene Zamikeracel for Recessive Dystrophic Epidermolysis Bullosa (RDEB) in the Post-Marketing Setting
Prademagene Zamikeracel
Recessive Dystrophic Epidermolysis Bullosa
NCT07700966Enrollment250StartJul 2025Primary CompletionApr 2045est.CompletionApr 2045est.
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Completed | MuGard, Control Rinse | NCT01283906 |
| Phase 4 | Not yet recruiting | Non-conforming pz-cel surgical application to RDEB wounds, Pz-cel surgical application to DEB wounds | NCT07717736 |
| Phase 3 | Completed | ofloxacin, MSI-78 | NCT00563394 |
| Phase 3 | Completed | ofloxacin, MSI-78 | NCT00563433 |
| Phase 3 | Completed | EB-101 | NCT04227106 |
| Phase 3 | Active, not recruiting | EB-101 Surgical application of RDEB wounds | NCT05725018 |
| Phase 2 | Completed | EcoNail™ (econazole 5%/SEPA® 18% nail lacquer) | NCT00385502 |
| Phase 2 | Completed | amlexanox, Vehicle rinse | NCT01083875 |
| Phase 1/2 | Completed | LZRSE-Col7A1 Engineered Autologous Epidermal Sheets | NCT01263379 |
| Phase 1/2 | Terminated | rAAV9.CMV.hNAGLU | NCT03315182 |
| Observational | Terminated | ABO-101 | NCT04655911 |
| Observational | Enrolling by invitation | EB-101 | NCT05708677 |
| Observational | Recruiting | Prademagene Zamikeracel | NCT07700966 |