13therapeutics, Inc.

Competitive Products: There are no approved therapeutics for the treatment of middle ear inflammation, residual fluid, and hearing loss associated with otitis media.  Antibiotics do not resolve fluid accumulation or improve hearing.  Antihistamines, decongestants, and steroids are NOT recommended.

We hypothesize treatment with P13 will reduce or eliminate the fluid that persists after the clinical symptoms of AOM resolve, ultimately improving hearing thresholds, reducing recurrent infections, and reducing the number of patients that are candidates for tympanostomy surgery.  We  propose to treat AOM patients in the pediatrician's office upon diagnosis of AOM.  With the number of office visits in the US/year for AOM being at least 16 million, we predict a billion dollar market for the therapeutic use of P13 to treat patients diagnosed with AOM. P13 has demonstrated efficacy in preclinical models of AOM.

Acute Otitis Media (AOM) is defined as the rapid onset of signs and symptoms of inflammation in the middle ear and is characterized by fluid development.  AOM is treated either by antibiotics or watchful waiting, and clinical symptoms, such as fever and ear pain, normally resolve in 2-3 days.  In 2000, the total number of office vistis for acute otitis media in the US was 16 million.  In the majority of AOM cases, fluid persists in the middle ear after the clinical symptoms have resolved and studies have shown that in 54% of children, fluid remains 6 weeks or longer after the infection resolves. Cases of persistent middle ear fluid without other clinical signs of infection are labeled as otitis media with effusion (OME). Fluid in the middle ear can result in hearing loss and can effect speech, language, and learning.

Otiits Media with Effusion (OME) is defined as the presence of fluid in the middle ear without signs or symptoms of acute ear infection, and generally occurs as an inflammatory response following Acute Otits Media (AOM).  Persistent middle-ear fluid from OME results in decreased mobility of the tympanic membrane and serves as a barrier to sound conduction.  Approximately 2.2 million diagnosed episodes of OME occur annually in the US with a combined direct and indirect cost estimate of $4 billion.  Many more cases remain undiagnosed, as there are no associated clinical sympoms such as fever and ear pain.  The effects of OME include hearing loss; effects on speech, language, and learning; physiologic sequelae; health care utilization (medical, surgical); and quality of life.  OME is also correlated with recurrent infections. When the hearing loss resulting from OME meets certain criteria, surgery to insert tympanostomy tubes is recommended.  Surgery for t-tube insertion is performed under general anesthesia at an approximate cost of $5,000 per procedure with approximately 700,000 tympanostomy surgeries performed annually in the United States.