Through H2/22, this biopharma intends to keep advancing its psychedelic drug formulations for major depression, noted a ROTH Capital Partners report.
Small Pharma Inc. (DMTTF:OTCQB) plans to continue advancing two drug candidates for major depressive disorder this year, leading to possible stock catalysts, reported ROTH Capital Partners analyst Elmer Piros in a May 25th research note.
Also of note, the potential return for investors of Small Pharma is in multi-bagger territory, given the current share price is around CA$0.15 and ROTH’s target price on it is more than 30 times that, at CA$5. ROTH’s recommendation on the company is Buy.
The England-based firm’s drugs, SPL026 and SPL028, are proprietary versions of the psychedelic, DMT, or N, N-dimethyltryptamine.
Small Pharma’s management, in its recent clinical update, reiterated that the more advanced of the two, SPL026 (injectable DMT fumarate), is currently being evaluated in combination with talk therapy, in an in-progress Phase 2 trial in the United Kingdom, Piros noted. Results of this study now are expected in H2/22, pushed back from H1/22 because of enrollment delays due to COVID-19.
Significantly, Small Pharma added two trials to its SPL026 development program, which it plans to launch this year.
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One, a drug interaction study, will evaluate the impact of antidepressants used in conjunction with SPL026 in major depressive disorder. In the study, patients taking selective serotonin reuptake inhibitors (SSRIs) without success will be compared to patients not taking them. If patients on SSRIs could successfully supplement their depression therapy with SPL026, this would expand the patient base and market for Small Pharma’s drug.
Encouragingly, “a recent study with psilocybin combined with SSRIs did not result in adverse effects in healthy volunteers,” Piros relayed.
The second SPL026 study will be another Phase 1, to be done using healthy volunteers, in which intramuscular versus intravenous SPL026 formulations and administration will be assessed. Intramuscular administration would afford patients easier access to and more convenient delivery of SPL026.
Regarding SPL028 (injectable deuterated DMT), it is on the verge of moving from the preclinical into the clinical phase, wrote Piros. In H2/22, Small Pharma intends to launch a Phase 1 trial of SPL028, also in major depressive disorder, using intramuscular and intravenous formulations.
With SPL028, the company aims to deliver a longer psychedelic experience than that experienced with SPL026. If achieved, SPL028 might be used to help treat other mental health ailments.
“In vitro data indicate that with SPL028, there was a reduction of clearance and a significant extension of half-life (when compared to SPL026), indicating a potentially longer duration (greater than 30 minutes) in upcoming human clinical trials,” added Piros.
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Disclosures for Roth Capital Partners, Small Pharma Inc., May 25, 2022
Regulation Analyst Certification (“Reg AC”): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
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