Oricula Therapeutics Hopes to File for FDA Approval This Year

It appears that this refers to an IND application rather than an NDA. Assuming the IND (Investigational New Drug) application is approved, they will be able to start clinical trials. At the other end of the process - after a Phase 3 trial, they would submit an NDA (New Drug Application).

There's a thread from last year about Oricula though it is important to note that "Phase 2" refers to the SBIR program, not clinical trials: https://www.tinnitustalk.com/threads/new-phase-ii-grant-for-oricula-therapeutics-llc.13842/

 

"The drug that’s come out of all these studies, known as ORC-13661, is about 100 times more potent than PROTO-1 and actually works (in animals) to prevent both antibiotic- and cisplatin-related hair-cell loss."

Anyone know the names of the actual chemical compounds? I searched everywhere and couldn't find any info. Is it related to d-methionone?

EDIT: Nevermind, I see they just screened a ton of small molecule drugs for activity.

 

This is VERY exciting news!!! Just think of how many people this will help for their tinnitus not to get massively worse, or to even get it at all. I am so happy that they are finally about to go to trials. This is a very good day!

 

A Clinical Trial for a New Drug to Protect Hearing
The U.S. Food and Drug Administration (FDA) has approved a novel drug to protect against ototoxicity (harmfulness to hearing) due to the use of aminoglycoside antibiotics to treat severe infections. The FDA approval paves the way for a Phase I clinical trial to test whether the drug, found to be significantly protective in animals, is safe for humans.

 

Decibel Therapeutics and Oricula Therapeutics Announce Exclusive License for ORC-13661 in Phase 1 Development for Hearing and Balance Protection

A new hope for patients facing irreversible ototoxicity resulting from the use of an important class of antibiotics

Boston, Mass. and Seattle, WA, September 27, 2018 – Decibel Therapeutics and Oricula Therapeutics today announced that Decibel has obtained an exclusive, worldwide license to the development and commercialization of ORC-13661, an oral medication developed by Oricula Therapeutics for the prevention of hearing loss and balance disorders that can occur following treatment of severe infections with aminoglycoside antibiotics. Particularly susceptible populations include those treated for pulmonary exacerbations associated with cystic fibrosis, non- tuberculous mycobacterial infections, multidrug-resistant tuberculosis, and endocarditis. As part of the agreement, Oricula will provide ongoing scientific advice and support.

With roots in a research collaboration between the University of Washington and the Fred Hutchinson Cancer Research Center, ORC-13661 was licensed to Oricula Therapeutics in 2013 to accelerate preclinical research activities and advance the compound into the clinic. A Phase I clinical trial to evaluate safety, tolerability and pharmacokinetics is currently ongoing.

About ORC-13661
ORC-13361 is a new chemical entity (NCE) currently being investigated for the prevention of ototoxicity which results from treatment with aminoglycoside antibiotics. It is thought to work by temporarily blocking aminoglycosides from entering into hair cells in the inner ear, thereby preventing damage before it can occur. Two relevant composition of matter patents, valid through 2036, have been granted by the USPTO and related global filings are in process. ORC- 13661 is also referred to as DB-041.