Zelira Therapeutics Meets Primary Endpoints for Phase (1b/2a) Medicinal Cannabis Trial for Insomnia
PR Newswire•February 18, 2020
- 23 chronic insomnia patients treated with ZLT-101, Zelira's proprietary and patented medicinal cannabis formulation, demonstrated statistically significant improvement in Insomnia Severity Index scores compared to placebo
- ZLT-101 therapy was well tolerated, with no serious adverse events reported
- Positive trial results an important milestone for Zelira
- Poised to launch world's first clinically validated medicinal cannabis product for insomnia in 2020
- Expands Zelira's product portfolio alongside the HOPE™ product range
PERTH, Australia, Feb. 18, 2020 /PRNewswire/ --
Teleconference 11am (AEDT) today with
Osagie Imasogie, Zelira Chairman
and Dr Richard Hopkins, Managing Director-ex USA
Toll free dial-in (Australia): 1800 908 299
Conference ID: 10004335
(more dial in options p4)
Zelira Therapeutics Ltd (ASX: ZLD, OTCQB: ZLDAF), a global leader in the development of clinically validated cannabis medicines, today announced positive Phase 1b/2a results confirming that ZLT-101 therapy achieved the primary endpoint of a statistically significant improvement in Insomnia Severity Index scores in patients diagnosed with chronic insomnia.
The Phase 1b/2a trial recruited 24 chronic insomnia patients, aged between 25-70. The study was a randomised, double-blind, cross-over design involving 14 nights of ZTL-101 and 14 nights of placebo, separated by a one-week washout period. All participants underwent a monitored sensitivity test to a mixture of ZTL-101 and placebo prior to commencing dosing. When dosing commenced each participant was able to take a single (0.5ml of 11.5mg total cannabinoids) or double (1 ml of 23mg total cannabinoids) dose of the medication, delivered sublingually, according to their symptoms.
Of the 23 participants who completed the protocol, 12 (52%) chose to increase the ZTL-101 medication from a single dose (0.5ml/11.5mg total cannabinoids) to double dose (1.0ml/23mg total cannabinoids) of ZTL-101 (as measured on the 14th night). Sixteen participants (69.5%) were taking a double dose (1.0ml) of the placebo on the 14th night.
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