Vancouver, British Columbia – November 4, 2022 – Blackhawk Growth Corp. (CSE:BLR; Frankfurt:0JJ) (the “Corporation” or “Blackhawk”), is pleased to announce MindBio Therapeutics Pty Ltd (“MindBio”) has released data from a Phase 1 clinical trial microdosing Lysergic Acid Diethylamide (LSD) in 80 healthy participants.
MindBio is developing a medicinal microdosing treatment regimen using a special formulation and treatment protocol to treat Major Depressive Disorder (MDD) and is pleased to report positive data from Phase 1 clinical trials.
In total 136 participants were screened and 80 randomised into the trial.
Healthy male volunteers were randomised into LSD (n = 40) and placebo (n = 40) groups and received 14 doses of either 10 μg of LSD or inactive placebo every three days for six weeks. First doses were given under supervision, with other doses self-administered. Safety data, blinding, daily questionnaires, expectancy, and pre- and post-intervention psychometrics and cognitive tasks were measured and recorded.
1102 microdses (LSD/placebo) were administered in the trial with 100% adherence to regimen and no diversion of substances.
Daily questionnaires showed credible evidence (>99% posterior probability) of increased ratings of “energy”, “wellness”, “creativity”, “happiness” and “connectedness” on dose days relative to non-dose days, which persisted when controlling for pre-intervention expectancy.
Daily Visual Analogue Scales (VAS) scores were recorded. VAS can be used for subjective ratings of mood, emotion, distress, or other sensations such as pain. Of the 16 VAS scales, 7 had significant interaction effects which survived a Bonferroni corrected alpha level (α = 0.05/16 = 0.0031): ‘angry’, ‘connected’, ‘creative’, ‘energy’, ‘happy’, ‘irritable’, and ‘well’. Bayesian modelling showed a very similar pattern of results with the same measures having Bayesian 95% credible intervals which did not overlap 0, excluding ‘angry’. The analyses showed it was highly probable (>99.9%) that an effect existed for ‘energy’, ‘happy’, ‘well’ and ‘irritable’ and probable (>99%) that it existed for ‘connected’ and ‘creative’. There was a likely effect for ‘angry’ and ‘tired’
Analysis of AE data from all randomised participants (N = 80) shows the proportion of participants who experienced an AE in the LSD group was 85.0% and in the placebo group was 80.0%, the odds ratio (OR) was not statistically significant (OR = 1.4, 95% CI [0.4, 5.5], Fishers exact p = 0.77). Median severity for AEs was mild in both the LSD group and the placebo group. There were no deaths, serious or severe AEs in the study.
Proportion tests of the number of participants who experienced an event in each condition showed that only ‘jitteriness’ was statistically significant. The proportion of participants who experienced ‘jitteriness’ in the LSD group was 32.5%, and in the placebo group was 7.5%; the odds of reporting ‘jitteriness’ were significantly higher in the LSD group (OR = 5.62, 95% CI [1.6, 27.7], Fisher’s exact p = 0.01). Four participants were withdrawn from the LSD group due to the emergence of mild anxiety.
••Home based microdosing studies are feasible and practical
••AE profile of LSD microdosing is good (in data collected so far)
••Jitteriness can emerge in a subset of volunteers
••Subtle dose titration to optimise treatment regimen will be important for future trials
••The increases in, “energy”, “well”, “happy”, “creative”, “connected” are suggestive of anti-anhedonic properties that may have potential when used in patients with depression.
MindBio Co-founder Justin Hanka said “We are delighted by the positive data from Phase 1 clinical trials which is confirmatory for our investment in continuation Phase 2 clinical trials in patients suffering from Major Depressive Disorder which are due to start in the new year alongside a Phase 2 clinical trial in late stage cancer patients suffering existential distress”.
Fred Pels, Blackhawk CEO said “We are pleased to report positive outcomes in our clinical trials and we are excited about the progress we are making towards the commercialization of psychedelic medicines and finding more effective medical treatments for mental health conditions”.
About Blackhawk Growth
Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, Blum Distributors and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.
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For further information please contact:
Frederick Pels, Chief Executive Officer
Cautionary Note Regarding Forward-Looking Statement
All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to transaction and future operations of MindBio Therapeutics Pty Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.
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