NH901 is NHTherapeutic’s proprietary formulation and dosing regimen of leuprolide delivered orally using advanced formulation techniques and a unique dosing regimen that renders the product suitable for safely and chronically increasing levels of endogenous sex hormones. Leuprolide is a GnRH agonist approved throughout the world and is currently available as an injectable. NHT is using internal expertise in formulating blockbuster products like Lupron™ and Prevacid™ in order to optimize the reformulation of leuprolide. The product modulates the endogenous GnRH system and increases hormonal levels, without risk of overdose or reaching supratherapeutic levels.
Typically, chronic treatment of GnRH agonists is used to induce chemical castration. The resulting decrease in testosterone levels make GnRH agonists an effective treatment for indications such as prostate cancer. However, a unique and proprietary dosing regimen can be used to induce a sustained increase in testosterone.
NH901 is expected to increases sex hormones in a more physiological, pulsatile manner rather than inducing abnormal increases in plasma levels of sex hormones administered exogenously
NH901 aims to restore the physiological hypogonadal axis responsivity and function
Overdose, misuse and abuse are avoided, as off-schedule dosing will result in hypogonadal axis hyporesponsiveness ("safety-valve" mechanism)
Thus this provides a safe alternative to current treatment strategies both in terms of serious adverse events and abuse.
NHT intends to develop NH901 by further developing the formulation in order to enter the clinic early and to obtain bioavailability data. This will be followed by a single and multiple dose study, including proof of concept (POC) data. After completion of this study, discussions will be held with the American and European regulatory authorities regarding registration requirements. An application to the European Medicines Agency for orphan drug designation has been submitted.