Cellceutix has selected Dr. Reddy’s Custom Pharmaceutical Services (CPS) for the formulation of its defensin mimetic drug Brilacidin for use in ophthalmic and otitis infections.
Leo Ehrlich, CEO at Cellceutix, said: “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.
Dr. Reddy’s recently acquired OctoPlus in the Netherlands, which Ehrlich said: “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.”
The announcement also comes as Dr. Reddy’s was cited as a company with stock worth purchasing .
Laboratory research on Brilacidin demonstrated the safety and tolerability of Brilacidin against drug-sensitive and drug-resistant clinical isolate strains of ocular infections. Additional research by CRO Iris Pharma showed that Brilacidin has a high residence time on the surface of the eye with negligible systemic exposure.
“We are presently in a Phase 2b trial with Brilacidin for serious skin infections. Additional laboratory studies on Brilacidin have been ongoing…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,” 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,” Ananthanarayanan added.
Cellceutix also recently announced 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. Once all data are confirmed, Cellceutix plans to publish the results.
Acute otitis media is one of the most common pediatric illnesses and also a leading cause of conductive hearing loss.