PharmaTher Holdings Ltd. announced that it has initiated its Phase 2 KET-LID clinical trial of Ketamine for the treatment of Levodopa-Induced Dyskinesia in Subjects with Parkinsons Disease. Patient screening and enrollment is expected to begin in October 2021 with data anticipated in late-fourth quarter 2021. The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinsons disease. The primary and secondary endpoints are the changes in the following: i) total score of the Unified Dyskinesia Rating Scale (UDysRS), ii) total objective score (III, IV) of the UDysRS, iii) total daily OFF times as assessed by subject- completed 24-hour diaries, and iv) Unified Parkinson's Disease Rating Scale (UPDRS) total score of part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV. As previously announced on May 17, 2021, an IND for the trial has been approved by the FDA. The Company has completed its clinical trial start-up activities and selection of essential vendors including project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring. Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained. If the Phase 2 clinical study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.