NHPN-1010's clinical development
Hough Ear Institute (HEI) is doing everything we can to support our commercialization partner, Otologic Pharmaceutics, Inc. (OPI), as they push NHPN-1010 through a complicated and painstaking process towards FDA approval, but please understand, virtually all of these rate-limiting approval steps are completely out of HEI’s control.
NHPN-1010 was created by researchers at HEI and Oklahoma Medical Research Foundation (OMRF), and HEI was able to fund and support a majority of the pre-clinical development of this drug for hearing loss and auditory disorders – not typical of a small independent research institute due to the enormous cost associated with this kind of research and development. Now, we are at the point where a large pharmaceutical partner is needed to sub-license our therapeutic and pay for the rest of its clinical development through Phases II and III of the FDA approval process. This is not an easy task, because anyone who agrees to fund NHPN-1010’s clinical development is agreeing to an almost $500 million dollar investment in a single, first-in-class drug for this indication.
Our commercialization partner, OPI – who works as an agent for commercializing NHPN-1010 – found a pharmaceutical company willing to sub-license NHPN-1010 for Phase II clinical testing in 2020. In the middle of preparing NHPN-1010 for a Phase II trial this pharmaceutical partner shifted their focus away from developing therapeutics for hearing loss and decided to shift their focus towards developing therapeutics for cancer. This meant NHPN-1010’s license was returned to OPI to enable them to find another pharmaceutical company to sub-license NHPN-1010 for clinical development. This also meant a halt to NHPN-1010 entering into Phase II trials. OPI is now actively seeking another pharmaceutical company to fund the clinical development of NHPN-1010. HEI has no operational or administrative control over that process or its timing.
OPI is in the driver’s seat and working diligently to find a large pharmaceutical partner for completing the clinical development pathway for NHPN-1010. This is a lengthy process, sometimes years in the making, and these negotiations are conducted in complete privacy and confidence until they are officially signed. This means it could seem like nothing is happening while these agreements are in active negotiation. Once NHPN-1010 is sub-licensed to a pharmaceutical partner, its clinical fate is then fully in their control.
Those of you who are passionate about this clinical development process feel like part of our extended family. We know how distressing hearing loss and tinnitus can be. We are praying hard and pushing as much as we can to get this drug into the clinic.
It is our commitment to you to continue working towards FDA approval through the channels available to us and to continue keeping you informed about the progress of this process.