PharmaTher Holdings Ltd. announced an update on the Type C meeting with the U.S. Food and Drug Administration (FDA) for advancing KETARX™? (ketamine) towards Phase 3 clinical development as a treatment for levodopa-induced dyskinesia in Parkinson's disease (LID-PD). The FDA supported the Company's overall approach for the LID-PD program and offered the following feedback: Ag agreed that with the appropriate data, a new drug submission would be considered under the 505(b)(2) regulatory pathway; Confirmed that a single confirmatory trial can be the basis for marketing approval under specific circumstances, including treatment duration and final study results; Guided on treatment duration, use of evaluation scales and selection of endpoints to ensure treatment approach aligns with expectations for a chronic condition; provided information to enhance the safety monitoring to ensure potential physical and cognitive performance issues can be minimized, adverse events do not go unnoticed, and strategies to minimize patient risk; identified the need for certain short-term non-clinical studies to support increased treatment duration; and Advised the Company to make a formal submission to be considered for Fast Track designation.

The Company plans to adapt its proposed clinical development program to align with the FDA's recommendations and the Company's resources towards study evaluations leading into a Phase 3 clinical study and a potential FDA approval via the 505(b)(2") regulatory pathway. The Company will provide updates to its clinical development initiatives as they arise. The safety and efficacy results from its previously announced presentation of the Phase I/II clinical study evaluating ketamine as a potential new treatment for LID-PD will be used to support the investigation of KETARX™?

in a proposed Phase 3 clinical study. Summary results of the Phase I/II clinical study: Summary results of the Phase I/II clinical study: Enrolled subjects with moderate to advanced Parkinson's disease with a target infusion rate being 0.30 mg/kg/hr. Data highlight that ketamine was safe, well-tolerated, and demonstrated that 100% of subjects treated with ketamine had a reduction in dyskinesias as measured by UDysRS.

UDysRS showed a 51% reduction from baseline during Infusion 2 (p=0.003), 49% at 3 weeks (p=0.006) and 41% at 3 months (p=0.011) post-ketamine. The maximum tolerated infusion rate ranged from 0.20-0.30 mg/kg/hr, which was dependent on either discomfort due to dissociation or hypertension. There were no adverse events post-infusion.

PharmaTher retains rights to US Patent No: 11,426,366 (expires May 2036), titled “Compositions and Methods for Treating Motor Disorders,” which includes claims intended to cover ketamine in the potential treatment of Parkinson's Disease and motor disorders that cause involuntary or uncontrollable movement or actions of the body.