SBA News, 05.01.2017
- Single subconjunctival injection of Brimapitide (XG-102), a JNK inhibitor, after ocular surgery shown to be non-inferior to dexamethasone eye drops given 4 times daily for 21 days
- Phase II randomized, double blind, parallel group, controlled, multi-center trial of 145 patients in six French ophthalmology centers
- Brimapitide (XG-102) first peptide administered subconjunctivally for treating post-surgical inflammation
Xigen, a Swiss Company developing therapeutic peptides for the treatment of inflammatory diseases announces today the online publication of successful Phase II results for its lead compound Brimapitide (XG-102) in the American Journal of Ophthalmology.
Xigen’s innovative technology platform enables the design and synthesis of long-acting therapeutic peptides with a very high metabolic stability. The peptides, including the lead compound Brimapitide (XG-102), are designed to allow the efficient delivery of the active element to intracellular targets. In the case of Brimapitide this means the ability to selectively reach and inhibit c-Jun N-Terminal Kinase. Ophthalmology was chosen as a gateway to the treatment of more complex inflammatory diseases. The phase II study of 145 patients was designed as a controlled, multi-center, randomized, double-blind, parallel-group study to assess the efficacy and safety of a single sub-conjunctival injection of Brimapitide (XG-102) in comparison with repeated administration of dexamethasone eye drops in post-surgical intraocular inflammation. The study took place in France in six referral centers in the field of Ophthalmology in Paris, Grenoble, Dijon, Nancy, and Lyon. The overall development of Xigen’s lead product was carried out by Solid Drug Development SA, a specialized firm based in Geneva.
Brimapitide (XG-102) is a first in class innovative and well tolerated molecule. Phase I and phase Ib clinical studies conducted in Switzerland and France included twenty-four healthy volunteers and twenty patients with post traumatic or postoperative intraocular inflammation respectively. Both clinical studies results confirmed the safety and good tolerability of the compound, which has an excellent profile when administered directly into the eye. The multi-center phase II study results show the non-inferiority of a single sub-conjunctival injection of Brimapitide (XG-102) at the end of surgery compared to dexamethasone administered 4 times a day for 21 days. Xigen’s chairman, Mikhail Sazonov, said, “These excellent results from our multi-center Phase II trial of Brimapitide in ocular surgery, published in a leading medical journal, successfully demonstrate the power and potential of Xigen’s novel therapeutic peptides to efficiently deliver active elements to intracellular targets in inflammatory diseases.“
Xigen, a Swiss biopharmaceutical company founded as a spin-off of the Centre Hospitalier Universitaire Vaudois (CHUV), specializes in the research and development of innovative therapeutic peptides with a focus on inflammatory diseases. The Company’s technology has enabled the design and synthesis of cell-penetrating peptides with enhanced metabolic stability, using proprietary carrier motifs to selectively deliver them to intracellular targets in disease relevant cell types. Xigen’s lead compound Brimapitide (XG-102) is advancing through pre-clinical development with programs in ocular inflammation, urology, nephrology and Alzheimer’s disease.
About Solid Drug Development
Headquartered in Geneva, Solid Drug Development is a strategy and operations consultancy company specializing in the development of Pharma and Biotech products, handling all the processes that take a drug from the laboratory through to its marketing authorization. Active in most therapeutic areas including ophthalmology, immunology, endocrinology and oncology, the company has already successfully led the development of numerous pharmaceutical products including peptides, chemical entities, recombinant proteins as well as cell therapy projects.
About Brimapitide (XG-102)
Brimapitide (XG-102) is a highly selective, highly stable, long-acting peptide inhibitor of the enzyme JNK (c-Jun N-Terminal Kinase), which plays an essential role in the development of numerous autoimmune and inflammatory diseases. Due to the configuration "D" (dextro) of its 31 amino acids, Brimapitide (XG-102) demonstrates an increased resistance to proteases, the main factors involved in peptide degradation in the body.