March 30, 2017
January 6, 2017
SOLID's team is proud to announce a new success for Xigen's lead compound developed by Solid: Congratulations!
Xigen's Brimapitide, an innovative JNK inhibitor, delivers positive Phase II results in inflammatory eye disease
-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
Geneva, Switzerland, January 5, 2017: 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 thernfield 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 phasernIb 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 confirmedrnthe safety and good tolerability of the compound, which has an excellent profile when administered directly into the eye.
The multi-center phasernII 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."
Note to Editors
About Xigen
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.
For more information, visit: www.xigenpharma.com
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, nephrology 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.
For more information, visit: www.soliddrugdevelopment.com
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.
Issued for and on behalf of Xigen by Instinctif Partners.
Rapport d'activit?s 2011 CLARA, Canc?rop?le Lyon Auvergne Rh?ne-Alpes, 2012 www.canceropole-clara.com
PX?Therapeutics Licenses RIBOVAX?s SEBVI Technology for the Development and Manufacturing of Fully Human Monoclonal Antibodies
PX?Therapeutics SA (PX?T) and ribOvax Biotechnologies SA (Ribovax) have announced that they have entered into a licensing agreement to provide PX?T with access to Ribovax?s patented SEBVI Technology for the discovery and development of antibodies of entirely human origin.
SEBVI Technology utilises Epstein Barr Virus to immortalise and isolate circulating human B cells from the blood of immunocompetent individuals which secrete antigen-specific IgG antibodies. This technology enables the generation of high-affinity fully human antibodies that possess a reduced risk of inducing adverse reactions which are normally associated with non-human Ig epitopes. PX?T intends to use the SEBVI technological platform to offer an expanded range of services in the field of human monoclonal antibody development and production for diagnostic and therapeutic applications.?We are delighted to have signed this partnership with Ribovax to add SEBVI Technology to our growing service portfolio in the field of therapeutic antibodies?, said Tristan Rousselle, CEO and founder of PX?Therapeutics. ?This addition gives us a new strong platform for growth and will significantly enhance and complement our existing set of tools for the development and manufacturing of first-in-class therapeutic antibodies?.
?This agreement reflects Ribovax?s strategy to provide pharma companies with access to fully human therapeutic antibodies. Key to this approach is a privileged partnership with PX?Therapeutics that offer a fully integrated service from isolation and selection of the competent human B cells to the production of clinical lots in human cell lines?, said Mikhail Sazonov, member of the Ribovax Biotechnologies SA Board of Directors. He added: ?To ensure a quick technology installation at PX?Therapeutics Ribovax used the professional services of Solid Drug Development SA, an operational consultancy company founded by Ribovax?s previous CEO, Jean-Marc Combette.?
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ABOUT ribOvax Biotechnologies SA :
ribOvax Biotechnologies SA is a privately held company dedicated to the development of innovative antibody technology platforms and products in areas with clearly identified medical needs. Ribovax owns two proprietary technology platforms in the field of antibody engineering that have already delivered patented therapeutic and diagnostic fully human monoclonal antibodies. Ribovax has produced proprietary antibodies in the field of infectious diseases (HSV 1 and 2, CMV, Rubella, VZV) and oncology (anti-Alpha Enolase).Press release english - Press release french