OVID is a biopharmaceutical company focused exclusively on developing medicines for patients and families living with rare neurological disorders. Using recent scientific advances in genetics and the biological pathways of the brain, OVID has created a proprietary map of disease-relevant pathways to identify and acquire novel compounds for the treatment of rare neurological disorders. It is executing on its strategy by in-licensing and collaborating with leading biopharmaceutical companies and academic institutions.
Its most advanced candidate is OV101 for Angelman Syndrome, currently in a Phase 2 trial, which is primarily a safety trial designed to provide proof-of-concept on efficacy parameters. OV101 has also commenced a Phase 1 trial in adolescents with Angelman syndrome or Fragile X syndrome. Angelman Syndrome and Fragile X are both neurological disorders characterized by similar symptoms due to tonic inhibition. These symptoms include sleep disorder, aberrant behavior, anxiety, and cognitive or intellectual disabilities.
OV101 targets this diminished tonic inhibition. Specifically, OV101 is a differentiated selective GABA agonist. Gamma aminobutyric acid, or GABA, is an inhibitory neurotransmitter that plays a role in anxiety, sleep, seizures, motor functions and certain other brain functions. It believes that OV101, which we acquired from H. Lundbeck, is the only drug candidate in development with this mechanism of action.
Although the FDA has not yet made any determination regarding the safety and efficacy of OV101, in previously conducted clinical trials in primary insomnia enrolling over 4,000 adults, OV101 was observed to have favorable safety and oral bioavailability profiles.
OVID's second drug candidate is OV935. In January 2017, OVID entered into an agreement with Takeda Pharmaceutical Company to collaborate in the development and commercialization of its compound, TAK-935, which it refers to as OV935. OV935 is a potent, highly selective inhibitor of the enzyme cholesterol 24-hydroxylase, or CH24H. OVID believes, if approved, OV935 has the potential to become a first-in-class inhibitor of CH24H. CH24H is predominantly expressed in the brain, where it plays a central role in cholesterol homeostasis. It believes that by down-regulating the excitatory signals involved in epilepsy, OV935 offers the possibility not only to suppress seizures, as was observed in preclinical studies, but also to modulate the underlying biological pathways that lead to the development of seizures. OV935 has completed four Phase 1 trials demonstrating favorable tolerability at doses that are believed to be therapeutically relevant.
As a clinical stage biopharmaceutical, there is little in the way of financials at this point. It hasn't generated any revenue yet, nor does it expect to in the near future. For FY16, its net loss was ($22.4) million. On a pro forma basis, the company had cash and equivalents of $123.36 million as of December 31, 2016. It does not have any long term debt on the books.