Otic Pharma Announces Positive Results from a Phase 2 Trial of FoamOtic Externa, once-a-day, single
Otic Pharma Announces Positive Results from a Phase 2 Trial of FoamOtic Externa, once-a-day, single antibiotic, steroid free product for Acute Otitis Externa (AOE)
Rehovot, Israel, Jan 6, 2015 – Otic Pharma, a privately held biopharmaceutical company focused on the development of innovative retained, localized foam based products for Ear, Nose and Throat (ENT) disorders, announces positive clinical results of its lead product, FoamOtic Externa. A single agent, steroid free product was studied in a Phase 2 clinical trial with 220 minor and adult patients with Acute Otitis Externa (AOE). Once-daily dosing of FoamOtic Externa (ciprofloxacin 0.3% otic foam) demonstrated excellent safety and a similar clinical cure rate as twice-daily dosing of Ciprodex® ear drops (0.3% ciprofloxacin and 0.1% dexamethasone otic suspension, Alcon), the world leading marketed ear drops for AOE.
“We are very pleased with these positive results with once-daily dosing of FoamOtic Externa. Based on these data, we will be initiating a US-based Phase 3 trial with FoamOtic Externa during 2015 said Orna Palgi, Ph.D., executive Vice President of Otic Pharma. FoamOtic provides good coverage of the infected ear canal and the continued release of the drug allows once-daily dosing and better compliance which is a major advantage for kids. Based on the results the company is developing foam based products for additional ENT disorders”.
The randomized, multicenter, parallel, comparative Phase 2 trial enrolled patients, ages six months and older.
Proportion of subjects that did not require additional antimicrobial therapy at the end of the treatment period, the microbial eradication rate, time-to-end of pain and the disease recurrence rate, all being efficacy parameters, were found similar between FoamOtic Externa and Ciprodex®, the leading marketed ear drops for AOE. The overall Adverse Events (AEs) and Serious Adverse Events (SAEs) rates were similar between the two treatment groups indicating a similar safety profile.
“FoamOtic Externa is an effective product, easy to use, and was very well accepted by the patients. It enhances patient’s compliance since it is conveniently applied once a day. I will definitely recommend using this product based on patients’ feedback” said Dr. Shmuel Gur of Clalit Health Services - Pediatric Clinic, Kfar-Saba, Israel, an investigator in the study.
About FoamOtic Externa
FoamOtic Externa is a proprietary, foam-based extended-release formulation of ciprofloxacin antibiotic which has been designated for self-applied once-daily administration to treat AOE.
The FoamOtic platform addresses the inherent limitations of ear drops. The foam expands, providing good coverage of the infected area; it does not drip out of the ear and while collapsing provides continuous release of the active pharmaceutical ingredients. FoamOtic application is fast and easy, does not require tilting the head or lying on the side, can be self-administered and provides superior convenience compared to ear drops.
Clinical studies have demonstrated that once-daily administration of FoamOtic Externa provides sustained ciprofloxacin drug concentrations in the external ear canal that can successfully eradicate the pathogenic bacteria as with twice-daily dosing of antibiotic ear drops. The lead indication for FoamOtic is AOE in minor and adult patients. The product candidate completed a Phase 2 trial. Otic Pharma is preparing to launch in 2015 a pivotal phase 3 study of FoamOtic Externa to obtain the clinical data required for its approval by the FDA.
AOE or "swimmer's ear" is a generalized inflammation of the epithelium of the external ear canal which may also involve the pinna and/or the tympanic membrane. It is variably characterized by erythema, edema, increased sebum or exudates, and desquamation of the epithelium. AOE is a common, worldwide otologic problem occurring in humans mainly during hot and humid weather. The cause of AOE is water trapped in the ear canal; allowing bacteria that normally inhabit the skin and ear canal to multiply and to infect the ear canal, therefore over 90% of the cases of AOE are due to bacterial infections. The common treatment of AOE consists of topical antibiotics, with or without steroids, analgesia and water avoidance. Otic preparations are generally supplied in the form of ear drops. There are ~2.5M cases of AOE per year in the US with revenue of ~$500M.
About Otic Pharma, Ltd.
Otic Pharma established in 2008 is a clinical-stage company with a pipeline of improved, differentiated and user-friendly products for the treatment of ENT disorders, based on FoamOtic, a proprietary foam-based drug delivery system providing sustained exposure of drugs. Otic Pharma has three product candidates in development. FoamOtic Externa completed Phase 2 clinical trial in minor and adults AOE patients.
Orna Palgi, Ph.D.
EVP Otic Pharma
Office: +972 (73) 290 5820
Direct: +972 (73) 290 3831