The award supports preclinical studies to confirm that Oricula’s new chemical entities are both safe and effective for hearing protection. When complete, the results will form the basis for an FDA Investigational New Drug (IND) application to allow phase-one clinical trials to proceed.
If successful, Oricula’s product will be the first medicine to be FDA-approved to protect the inner ear from the damaging effects of antibiotics that are known to cause permanent hearing loss.
Oricula Therapeutics secured the grant to continue current research in therapeutics that effectively protect the hair cells in the inner ear from damage or death caused by certain antibiotics, specifically aminoglycosides (AGs).
The funded research has two primary objectives: 1) Using different strains of bacteria, confirm that the chemical entities do not interfere with the bactericidal effectiveness of the antibiotics and do not cause bacteria to mutate; and 2) Evaluate the safety and tolerability of the lead entity in mammals at specific dosage levels.
Oricula CEO Dr Malcolm Gleser said: "This is an exciting next step. During this phase, we’ll complete preliminary dose range-finding toxicology in the lead chemical entity, which positions us to start our GLP program towards IND filing and, ultimately, clinical trials."
Oricula Therapeutics has focused its research on protecting hearing from damage caused by AGs, an important and greatly underused class of antibiotics. Despite the known side effect of potential hearing damage, aminoglycosides are important for the treatment of a variety of serious infectious diseases including septicemia, multiple drug resistant TB, and pseudomonas infection in patients with cystic fibrosis.
However, because as many as 20% of patients treated with AGs develop measurable, irreversible hearing loss or even deafness, AGs – an inexpensive and effective antibiotic – have become a treatment of last resort. A medicine to effectively protect hearing, reducing or eliminating this safety concern, would open the door to broader worldwide use of this highly effective class of antibiotics.