SHX-001 is a transdermal delivery of racemic ketamine for treatment of major depressive disorders (MDD). The objective of SHX-001 is to fully transform the landscape of the use of ketamine for various CNS diseases, including MDD, by offering a convenient, safe and least abusive administration of ketamine with minimal side effects allowing out-patient use.
SHX-001 has completed the first in patient study, demonstrating expected absorption of ketamine, a supportive PK/PD relationship of ketamine and its metabolite (hydroxynorketamine, HNK, a likely antidepressant entity rather than parent ketamine entity), a clean safety profile with lack of dizziness, sedation, dissociation and other psychotomimetic effects. SHX-001 has been positioned for phase 2b study with a completion of discussion with FDA and agreements on the nonclinical requirements.
SHX-001 is based on a solid quantitative pharmacology that was developed by GDB, showing extensive nonclinical and clinical evidence that the major side effects associated with the high concentrations of parent drug ketamine can be separated from its antidepressant effects. SHX-001 is designed to offer a prolonged absorption of ketamine and maintain the effective PK concentrations of ketamine and HNK while below the threshold of ketamine concentration for major side effects.
SHX-001 has demonstrated a long-term patch shelf-life stability of over 2 years. Additionally, Shenox has established a global intellectual property position, having filled three PCT applications and obtained patent allowances from Japan, Korean, Australia, Canada and U.S.
SHX-001 is well positioned for development for other important indications including patient management, Rett Syndrome, and PTSD, once its proof of concepts is confirmed in Phase 2b in MDD patients.