PharmaTher and Case Western Reserve University (CWRU) have entered into an evaluation and exclusive option agreement for the development and commercialisation of ketamine to treat Rett Syndrome.
Under the deal terms, the company obtained an exclusive option for evaluating the regulatory, clinical development and commercialisation plan for CWRU’s intellectual property portfolio for up to 12 months.
CWRU’s portfolio includes US issued patent no. 11,213,494, US provisional patent no. 62/004,695 entitled, “Acute and sustained effects of low-dose ketamine treatment in mouse models of Rett Syndrome” and US provisional patent no. 62/004,695 entitled, “Acute and sustained effects of low-dose ketamine treatment in mouse models of Rett Syndrome.”
To enter into the agreement, PharmaTher made a one-time fee payment that is consistent with industry standards.
If the firm chooses to exercise its option, the two entities will negotiate a license agreement.
The company stated that Ketamine has the potential to treat Rett syndrome, a rare genetic neurological disorder that almost exclusively occurs in girls.
It has been independently validated in two different strains of Mecp2 mice in two different labs and has also completed a Phase II clinical study with Rett syndrome.
PharmaTher noted that the chronic administration of the drug was found to extend the lifespan and improve symptoms in null male Mecp2 mutants.
PharmaTher CEO Fabio Chianelli said: “We are pleased to have added the Rett syndrome programme to our clinical stage product pipeline that focuses on novel uses and delivery forms of ketamine in the treatment of mental health, neurological and pain disorders.
“In research, ketamine has shown the potential for treating Rett syndrome. We will work with CWRU and the clinical trial team in pursuing discussions with the FDA to determine all regulatory and clinical options that could expedite the pathway towards having ketamine available for Rett syndrome patients.”