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            Rapid and durable response͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;͏‌&nbsp;
        
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      <p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;margin-top:0;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:center;" class=""><strong>News release</strong></p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;margin-bottom:0;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:center;" class=""><strong>26 January 2023</strong></p>
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<table role="presentation" width="100%" cellpadding="0" cellspacing="0" border="0" bgcolor="#D3DDDF" class="text-section section-content">
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    <td valign="top" class="section-text-area section-content-cell padding-mobile-both" style="padding-top:11px;padding-right:44px;padding-bottom:11px;padding-left:44px;color:#313131;background-color:#d3dddf;">
      <p class="" style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;margin-top:0;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;">This week, a European psychedelic medicine company <a href="https://smallpharma.com/press-releases/positive-topline-results-from-phase-iia-trial-of-spl026-in-major-depressive-disorder/" rel="nofollow" style="color:#28b67e !important;">announced the results</a> of its Phase 2a clinical trial, treating moderate to severe Major Depressive Disorder (MDD) with DMT-assisted therapy.</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:15pt;" class="">The trial carries special significance, as it is the first-ever clinical trial attempting to treat a mental health disorder with DMT, the shorter-acting chemical cousin to psilocybin.</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:15pt;" class="">The study, which had 34 patients, delivered impressive results. </p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:0cm;" class=""><strong>3 months after a single dose of DMT — paired with preparation and integration therapy — 57% of depression patients were in remission. &nbsp;</strong></p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:0cm;" class=""><strong>&nbsp;</strong></p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:0cm;" class="">There was no therapeutic intervention during the psychedelic session. The entire process took between one hour and 45 minutes, to two and a half hours.</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:0cm;" class="">&nbsp;</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;" class="">There were no serious adverse events reported - DMT was found to be safe. There were 24 minor to moderate adverse events, such as nausea and anxiety, but all of these issues resolved themselves on the day of administration.</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;" class="">The psychedelic experience of DMT only lasts between 15-30 minutes, as compared to 4-6 hours for orally administered psilocybin. If DMT is found to be at least equally as effective in treating mental health disorders such as MDD, it could become the most practical, scalable and affordable psychedelic medicine.</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:15pt;" class="">While these preliminary results are very positive, it is only the very first clinical trial attempting to treat any mental health condition with DMT, and there was a relatively small sample size of 34 patients. Bigger sample sizes and more data will be needed to confirm these results and it would be desirable for the EU to support this research. </p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:15pt;" class="">Over the coming year, more DMT clinical trials will start. A six-month follow-up on the current trial will be announced as well. The company is also planning to launch a trial studying the interaction between DMT and SSRIs, the most common antidepressant.</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:15pt;" class="">PAREA Chair prof. David Nutt had this to say about the DMT trial results:</p><p style="color:inherit;font-size:.9375em;line-height:1.618em;margin:0 0 1.25em 0;font-weight:normal;font-family:'DejaVu Sans Condensed', 'Liberation Sans', 'Nimbus Sans L', 'Helvetica Neue', Helvetica, Arial, sans-serif;text-align:justify;margin-top:0cm;margin-bottom:15pt;" class=""><em>These are exciting findings as they suggest that even a short perturbation of brain function as occurs in a 20 min DMT trip can provide an enduring lifting of depression. It suggests that the psychedelic therapeutic process may derive from disruption of ongoing negative depressive thought loops (a “reset”) rather than by a more in-depth psychological insights as previously suggested by work with longer acting psychedelic such as psilocybin and LSD. A shorter treatment time obviously has major cost implications for the rolling out of psychedelic therapy as this DMT treatment regime would allow two or even three treatments per clinical room per day, as opposed to one currently.</em></p>
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