Beck Depression Inventory

Small Pharma Reports Positive Top-line Data from SPL026 (DMT)-SSRI Drug Interaction Study in Patients with Major Depressive Disorder

Retrieved on: 
Wednesday, September 27, 2023
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Alternative Medicine, Health, Pharmaceutical, Science, DMT, Inc., Depression, BDI, Major depressive disorder, Week, Pharmacokinetics, MADRS, Acquisition, MDD, Patient, Beck Depression Inventory, Beck, Phase, NYSE, Safety, NEO, Pharmaceutical industry, Vaccine, Selective serotonin reuptake inhibitor

This is impressive especially when combined with previously reported Phase IIa SPL026 efficacy data in MDD showing a rapid antidepressant effect and sustained remission to six months.

Key Points: 
  • This is impressive especially when combined with previously reported Phase IIa SPL026 efficacy data in MDD showing a rapid antidepressant effect and sustained remission to six months.
  • In the Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs, which can be a disruptive experience.
  • Through the SPL026-SSRI drug interaction study, Small Pharma aimed to address this requirement, which could enable broader patient recruitment on future large-scale studies, and potentially accelerate the clinical development pathway.
  • Efficacy was assessed using the Montgomery-Asberg Depression Rating scale (MADRS) to measure any change in patients’ depression symptoms from baseline.

Small Pharma Reports Positive Top-line Data from SPL026 (DMT)-SSRI Drug Interaction Study in Patients with Major Depressive Disorder

Retrieved on: 
Tuesday, September 26, 2023
DMT, Depression, BDI, Week, Pharmacokinetics, MADRS, Science, MDD, Patient, Beck Depression Inventory, Beck, Phase, SSRI, Safety, Major depressive disorder, Pharmaceutical industry, Vaccine, Selective serotonin reuptake inhibitor

LONDON, Sept. 26, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today announces positive safety, tolerability and efficacy data from its Phase Ib study exploring the interaction between selective serotonin reuptake inhibitors (“SSRIs”) and SPL026, native N, N-dimethyltryptamine (“DMT”), in patients with Major Depressive Disorder (“MDD”).

Key Points: 
  • In the Phase I/IIa SPL026 study, patients were required to be withdrawn from SSRIs, which can be a disruptive experience.
  • Through the SPL026-SSRI drug interaction study, Small Pharma aimed to address this requirement, which could enable broader patient recruitment on future large-scale studies, and potentially accelerate the clinical development pathway.
  • Additionally, removing the requirement to be withdrawn from SSRIs may facilitate patient access to SPL026 earlier in the MDD treatment journey, if approved.
  • Efficacy was assessed using the Montgomery-Asberg Depression Rating scale (MADRS) to measure any change in patients’ depression symptoms from baseline.

Clinical Trial of Arcade Therapeutics' Flagship Therapeutic Mobile Game, StarStarter Rx, Shows Robust Reductions in Social Anxiety in Adults

Retrieved on: 
Thursday, March 23, 2023
Arcade, Liebowitz social anxiety scale, Anxiety, Policy, COVID-19, SAD, Document Number Nine, Document, DSM-IV codes, Food and Drug Administration Amendments Act of 2007, Patient, Beck Depression Inventory, LSAS, Social anxiety disorder, Generalized anxiety disorder, Beck, FDA, Therapy, Social anxiety, Food, Safety, Nursing, Pharmaceutical industry

Arcade's clinical research uses a gold-standard placebo sham in research studies that isolates and controls for the therapy's mechanism of action.

Key Points: 
  • Arcade's clinical research uses a gold-standard placebo sham in research studies that isolates and controls for the therapy's mechanism of action.
  • "We are thrilled by these promising results as we continue down the path toward FDA submission of StarStarter Rx as the first game-based treatment for Social Anxiety Disorder."
  • StarStarter Rx is available with the Arcade Connect DTx deployment platform, which includes integration features, clinical assessments, and HIPAA-consent management.
  • StarStarter Rx is not intended for use as a standalone therapy and does not represent a substitution for your medication.

Small Pharma Announces Further Positive Data from SPL026 Phase IIa Trial in Major Depressive Disorder Strengthening Topline Efficacy Results

Retrieved on: 
Tuesday, March 7, 2023
Mental, Phase, CFB, BDI, Anxiety, Depression, Beck Depression Inventory, N,N-Dimethyltryptamine, IV, Safety, Major depressive disorder, Beck, Patient, MDD, MADRS, Pharmaceutical industry, N

LONDON, March 07, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, today announces further positive results from the Company’s Phase IIa trial of SPL026, the first placebo-controlled study of a short-duration psychedelic for the treatment of Major Depressive Disorder (“MDD”). The trial investigated the efficacy and safety of a 21.5mg intravenous (“IV”) dose of SPL026, N,N-Dimethyltryptamine (“DMT”), with supportive therapy in 34 patients with moderate/severe MDD. Analyses of additional secondary and exploratory endpoints, including effects on self-reported depression, anxiety and wellbeing, demonstrated that patients receiving at least a single dose of IV SPL026 with supportive therapy experienced clinically relevant improvements in function and mood, further supporting previously announced topline efficacy results.

Key Points: 
  • The trial investigated the efficacy and safety of a 21.5mg intravenous (“IV”) dose of SPL026, N,N-Dimethyltryptamine (“DMT”), with supportive therapy in 34 patients with moderate/severe MDD.
  • The two-staged study included a two-week blinded, randomized, placebo-controlled phase followed by a 12-week open-label phase, in which all participants received a single dose of SPL026.
  • SPL026 with supportive therapy also demonstrated a rapid onset and durable antidepressant effect, as assessed by the Montgomery-Asberg Depression Rating Scale (“MADRS”).
  • Further analysis of the Phase IIa dataset is ongoing and full trial results will be submitted for publication in a peer-reviewed journal.

Khondrion announces sonlicromanol Phase IIb progress supporting Phase III development in MELAS spectrum disorders

Retrieved on: 
Tuesday, November 22, 2022
Human voice, Deafness, MT-TL1, Learning, Mitochondrial disease, Cell, Cognition, Enzyme, Clinician, Natural history study, Mitochondrial encephalomyopathy, RAND, Leigh syndrome, Conference, Neuro, Pain, Degenerative disease, Fatigue, Exercise, CFQ, Growth, BDI, DNA, Life, Phase, Lactic acidosis, Global health, Jungian cognitive functions, Diabetes, Research, Severe cognitive impairment, Safety, Gross, Pharmacokinetics, Mutation, Heart failure, Beck, Mitochondrion, Muscle weakness, Government, Point mutation, Collection, Quality of life, Beck Depression Inventory, IIB, Pharmaceutical industry, Medical imaging, Medical device, Patient, MELAS, MIDD

Sonlicromanol, Khondrions wholly-owned lead asset, is being investigated in the Phase IIb programme in adult patients with MELAS spectrum disorders as genetically confirmed by the m.3243A>G mutation in the mitochondrial DNA.

Key Points: 
  • Sonlicromanol, Khondrions wholly-owned lead asset, is being investigated in the Phase IIb programme in adult patients with MELAS spectrum disorders as genetically confirmed by the m.3243A>G mutation in the mitochondrial DNA.
  • In line with previous studies, sonlicromanol was found to be safe and well tolerated in the Phase IIb programme, with no serious adverse effects.
  • These longer-term patient data are, therefore, instrumental in providing valuable insights for the design of the upcoming Phase III trial.
  • One of the most advanced disease-modifying drug candidates for mitochondrial disease in development, sonlicromanol has recently completed a Phase IIb study in adult patients with m.3243A>G MELAS spectrum disorders.

Khondrion announces sonlicromanol Phase IIb progress supporting Phase III development in MELAS spectrum disorders

Retrieved on: 
Tuesday, November 22, 2022
Human voice, Deafness, MT-TL1, Learning, Mitochondrial disease, Cell, Cognition, Enzyme, Clinician, Natural history study, Mitochondrial encephalomyopathy, RAND, Leigh syndrome, Conference, Neuro, Pain, Degenerative disease, Fatigue, Exercise, CFQ, Growth, BDI, DNA, Life, Phase, Lactic acidosis, Global health, Jungian cognitive functions, Diabetes, Research, Severe cognitive impairment, Safety, Gross, Pharmacokinetics, Mutation, Heart failure, Beck, Mitochondrion, Muscle weakness, Government, Point mutation, Collection, Quality of life, Beck Depression Inventory, IIB, Pharmaceutical industry, Medical imaging, Medical device, Patient, MELAS, MIDD

Sonlicromanol, Khondrions wholly-owned lead asset, is being investigated in the Phase IIb programme in adult patients with MELAS spectrum disorders as genetically confirmed by the m.3243A>G mutation in the mitochondrial DNA.

Key Points: 
  • Sonlicromanol, Khondrions wholly-owned lead asset, is being investigated in the Phase IIb programme in adult patients with MELAS spectrum disorders as genetically confirmed by the m.3243A>G mutation in the mitochondrial DNA.
  • In line with previous studies, sonlicromanol was found to be safe and well tolerated in the Phase IIb programme, with no serious adverse effects.
  • These longer-term patient data are, therefore, instrumental in providing valuable insights for the design of the upcoming Phase III trial.
  • One of the most advanced disease-modifying drug candidates for mitochondrial disease in development, sonlicromanol has recently completed a Phase IIb study in adult patients with m.3243A>G MELAS spectrum disorders.