Brilacidin-Otic is a novel topical anti-infective drug to treat ear infections. Often children with a history of frequent ear infections (otitis media) will have tubes placed in their tympanic membranes, which allows drainage into the external ear canal. In addition, children may develop an infection confined to the external ear canal. In either case, Brilacidin Otic could be helpful. Brilacidin-Otic topical drops can be applied directly to the infection, targeting difficult-to-treat bacteria such as Staph aureus, including methicillin-resistant Staph aureus (MRSA).
Brilacidin-Otic belongs to a completely new class of antibiotics called defensin-mimetics. The defensin-mimetic antibiotics are modeled after host defense proteins, which are the “front-line” of defense in the human innate immune system. Brilacidin-Otic kills bacteria in the same manner as the human host defense proteins, and in this regard, can significantly reduce the risk of bacterial resistance.
Brilacidin-Otic has shown excellent results in labratory testing of middle ear (otitis media) infection. In a Chinchilla model study of Otitis Media, Brilacidin-Otic drastically reduced the number of bacterial counts of Streptococcus pneumoniae, another common ear pathogen, in the middle ear space and had no toxic effect. The Company has selected Dr. Reddy’s Laboratories Ltd. for the formulation of this drug.
There are approximately 600 clinician visits per 1000 children per year for acute otitis media, and draining otitis media represents a portion of these patients. There are approximately 24 million children age 0 to 5 in the US. Otitis media is most prevalent in that group.
In the U.S., the current therapy for draining middle ear infections, as well as external ear infections, is Ciprodex, which is the combination of an antibiotic (ciprofloxacin) and a steroid (dexamethasone). It is administered topically into the external ear canal, and it covers relevant pathogens; however, its activity against MRSA is not optimal. Brilacidin-Otic represents a viable alternative to standard therapy, especially when MRSA is suspected. In addition, given the innate anti-inflammatory properties of the defensin-mimetics, it is likely that Brilacidin Otic may not require co-administration of a steroid..
Sales of Ciprodex, the standard therapy, have been substantial, and Brilacidin Otic could capture a portion of this market. Please see http://www.drugs.com/top200.html
