Cellceutix Corporation has announced that the Company has concluded negotiations with formulation developers and selected Dr. Reddy’s Custom Pharmaceutical Services (CPS), part of the Pharmaceutical Services and Active Ingredients (PSAI) business unit of Dr. Reddy’s Laboratories Ltd. (“Dr. Reddy’s”), a New York Stock Exchange-listed company traded under the ticker “RDY”, for the formulation of the Company’s defensin mimetic drug Brilacidin for use in ophthalmic and otitis infections.
Laboratory research on Brilacidin conducted at the Charles T. Campbell Ophthalmic Microbiology Laboratory demonstrated the safety, tolerability and broad activity of Brilacidin against drug-sensitive and drug-resistant clinical isolate strains of ocular infections.
Additional research by Contract Research Organization Iris Pharma showed that Brilacidin has a high residence time on the surface of the eye with negligible systemic exposure, suggesting that Brilacidin has the potential to treat ophthalmic infections, such as conjunctivitis and keratitis, with a limited dosing regimen.
Cellceutix is pleased to report that in an ongoing study, Brilacidin has shown excellent results in preliminary testing of middle ear (otitis media) infection. In the study done in the Chinchilla Model of Otitis Media, Brilacidin drastically reduced the number of bacterial counts of Streptococcus pneumonia in the middle ear and had no toxic effect.
Chinchilla otitis models are an excellent indicator if the drug will work in humans. We are waiting for additional pathology results and additional testing is planned. Once all data is confirmed, Cellceutix will publish the results.
Acute otitis media is one of the most common pediatric illnesses and also a leading cause of conductive hearing loss. About 2.2 million cases of otitis media with ear effusion occur annually in United States. Over seven hundred million (700,000,000) cases of acute otitis media occur worldwide each year.
Ear infection joins the growing list of indications of treatment of disease in which Brilacidin has potent efficacy.
“We are presently in a Phase 2b trial with Brilacidin for serious skin infections. Additional laboratory studies on Brilacidin have been ongoing and I am pleased to say we are more impressed than ever on the drug’s potential. Due to the unique properties of Brilacidin as a defensin mimetic and a possible one-time or even a three-day drug treatment to patients, we see an FDA approved Brilacidin for ABSSSI having the potential to knock off the present market leader who is presently generating approximately $1,000,000,000 in yearly sales. Expanding our Brilacidin franchise as a potential new therapy for eye and inner ear infections is a very important project for us as we view the aggregate market potential for these indications as very significant,” comments Leo Ehrlich, Chief Executive Officer at Cellceutix.
Ehrlich continued, “After undertaking an intense due diligence process to identify the best formulator for the job, Dr. Reddy’s was the clear choice as they have shown a deep understanding of what we want to accomplish. Their recent acquisition of OctoPlus in the Netherlands was a big addition to their already highly talented team as OctoPlus specializes in complex formulations. We are extremely optimistic about Brilacidin for ophthalmic and ocular indications based upon research to date and look forward to having this potentially game-changing drug in more clinical trials.”
Commenting on this development, Dr. R Ananthanarayanan, President, PSAI Business, Dr. Reddy’s said, “Dr. Reddy’s CPS has extensive knowledge in manufacturing and formulating anti-infective therapeutics. We are already working with Cellceutix on the manufacturing of Prurisol™ and are excited to work with them on the development of Brilacidin. Our expertise in both APIs and formulation development will assist Cellceutix in the clinical progression of Brilacidin.”