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    PHRM   CA71716H1082

PHARMATHER HOLDINGS LTD.

(PHRM)
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PharmaTher Holdings Ltd. Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’S Disease

10/06/2021 | 09:03am EST

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 Parkinson’s 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 Parkinson’s 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.


© S&P Capital IQ 2021
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Financials
Sales 2022 - - -
Net income 2022 - - -
Net Debt 2022 - - -
P/E ratio 2022 -
Yield 2022 -
Capitalization 31,1 M 24,4 M 24,3 M
Capi. / Sales 2022 -
Capi. / Sales 2023 -
Nbr of Employees -
Free-Float 77,5%
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Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 1
Last Close Price 0,36 CAD
Average target price 5,00 CAD
Spread / Average Target 1 289%
Managers and Directors
Fabio Chianelli Chairman & Chief Executive Officer
Carmelo K. Marrelli Chief Financial Officer
Owen van Cauwenberghe Head-Research & Development
Beverly James Incledon Director
Christian Scovenna Director
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