(TheNewswire)
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 trialmicrodosing Lysergic Acid Diethylamide (LSD) in 80 healthyparticipants.
MindBio is developing a medicinal microdosing treatmentregimen using a special formulation and treatment protocol to treatMajor Depressive Disorder (MDD) and is pleased to report positive datafrom Phase 1 clinical trials.
In total 136 participants were screened and 80randomised into the trial.
Healthy male volunteers were randomised into LSD (n =40) and placebo (n = 40) groups and received 14 doses of either 10 ?gof LSD or inactive placebo every three days for six weeks. First doseswere given under supervision, with other doses self-administered.Safety data, blinding, daily questionnaires, expectancy, and pre- andpost-intervention psychometrics and cognitive tasks were measured andrecorded.
1102 microdses (LSD/placebo) were administered in thetrial with 100% adherence to regimen and no diversion ofsubstances.
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, whichpersisted when controlling for pre-intervention expectancy.
Daily Visual Analogue Scales (VAS) scores wererecorded. VAS can be used for subjective ratings of mood, emotion,distress, or other sensations such as pain. Of the 16 VAS scales, 7had significant interaction effects which survived a Bonferronicorrected alpha level (? = 0.05/16 = 0.0031): ‘angry’,‘connected’, ‘creative’, ‘energy’, ‘happy’,‘irritable’, and ‘well’. Bayesian modelling showed a verysimilar 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 aneffect 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 inthe LSD group was 85.0% and in the placebo group was 80.0%, the oddsratio (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 inboth 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 whoexperienced an event in each condition showed that only‘jitteriness’ was statistically significant. The proportion ofparticipants who experienced ‘jitteriness’ in the LSD group was32.5%, 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). Fourparticipants were withdrawn from the LSD group due to the emergence ofmild anxiety.
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•• Home based microdosingstudies are feasible and practical
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•• AE profile of LSDmicrodosing is good (in data collected so far)
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•• Jitteriness can emerge in asubset of volunteers
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•• Subtle dose titration tooptimise treatment regimen will be important for futuretrials
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•• The increases in,“energy”, “well”, “happy”, “creative”, “connected”are suggestive of anti-anhedonic properties that may have potentialwhen used in patients with depression.
MindBio Co-founder Justin Hanka said “We aredelighted by the positive data from Phase 1 clinical trials which isconfirmatory for our investment in continuation Phase 2 clinicaltrials in patients suffering from Major Depressive Disorder which aredue to start in the new year alongside a Phase 2 clinical trial inlate stage cancer patients suffering existential distress”.
Fred Pels, Blackhawk CEO said “We are pleased toreport positive outcomes in our clinical trials and we are excitedabout the progress we are making towards the commercialization ofpsychedelic medicines and finding more effective medical treatmentsfor mental health conditions”.
About Blackhawk Growth
Blackhawk is an investment holding company looking tocreate substantial value for its shareholders through the acquisitionand development of high growth companies. It has focused itsinvestments in the health, cannabis and cannabidiol industries in bothCanada and the United States. Its portfolio of companies includes SacPharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods,Blum Distributors and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow andis growing at an exceeding pace.
The Company diligently posts updates through videosfrom the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A
Please join the conversation on our Blackhawk groupsupporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com .
For further information please contact:
Frederick Pels, Chief ExecutiveOfficer
(403)-991-7737
fred@ blackhawkgrowth.com
Cautionary NoteRegarding Forward-Looking Statement
All statements in this pressrelease, other than statements of historical fact, are “forward-looking information”with respect to the Company within the meaning of applicablesecurities laws, including with respect to transaction and futureoperations of MindBio Therapeutics Pty Ltd. The Company providesforward-looking statements for the purpose of conveying informationabout current expectations and plans relating to the future andreaders are cautioned that such statements may not be appropriate forother purposes. By its nature, this information is subject to inherentrisks and uncertainties that may be general or specific and which giverise to the possibility that expectations, forecasts, predictions,projections or conclusions will not prove to be accurate, thatassumptions may not be correct and that objectives, strategic goalsand priorities will not be achieved. These risks and uncertaintiesinclude but are not limited those identified and reported in theCompany’s public filings under the Company’s SEDAR profile atwww.sedar.com. Although the Company has attempted to identifyimportant factors that could cause actual actions, events or resultsto differ materially from those described in forward-lookinginformation, there may be other factors that cause actions, events orresults not to be as anticipated, estimated or intended. There can beno assurance that such information will prove to be accurate as actualresults and future events could differ materially from thoseanticipated in such statements. The Company disclaims any intention orobligation to update or revise any forward-looking information,whether as a result of new information, future events or otherwiseunless required by law.
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