Selective serotonin reuptake inhibitor

Beckley Psytech receives FDA Investigational New Drug (IND) approval for Phase IIb study of BPL-003, a novel synthetic formulation of 5-MeO-DMT (Mebufotenin)

Retrieved on: 
Tuesday, February 21, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Mental Health, Clinical Trials, Safety, TRD, Depression, Investigational New Drug, Drug development, Treatment, Selective serotonin reuptake inhibitor, IND, Major depressive disorder, Patient, Beckley Foundation, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Atypical depression, AUD, MADRS, DSM-IV codes, MDD, Food, Phase, 5-MeO-DMT, Pharmaceutical industry

BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.

Key Points: 
  • BPL-003 is Beckley Psytech’s novel synthetic formulation of the psychedelic compound 5-MeO-DMT (also known as Mebufotenin) and is administered intranasally via an FDA-approved delivery device.
  • This IND marks the first time the FDA has ever given IND approval for a Phase IIb study of a short-acting psychedelic treatment or a 5-MeO-DMT treatment.
  • The study will be conducted with the help of 40 investigator sites in 7 different countries and is due to be initiated in H1 2023.
  • Phase I data has already shown BPL-003 to be well-tolerated with consistent dose delivery and a reproducible, dose-linear pharmacokinetic profile.

Reunion Neuroscience Provides Business Update and Reports Fiscal Third Quarter 2023 Financial Results

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Tuesday, February 14, 2023
Bank statement, GSK, Woman, Mother, TSX, Data analysis, Investment, PPD, IAS, ID, Safety, Patient, Depression, Webcast, International Financial Reporting Standards, Reunion, Congress, Takeda, Psilocybin, Psychopharmacology, International, FDA, Consciousness, Research, Wellness, Spinout, AstraZeneca, Drug discovery, Toronto Stock Exchange, Selective serotonin reuptake inhibitor, Management, Pharmaceutical industry, Audit, Cryptocurrency, Pfizer, Merck

TORONTO, Feb. 14, 2023 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc. (NASDAQ: REUN, TSX: REUN) (“Reunion” or “the Company”), a clinical-stage biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions, today provided a business update and reported fiscal results for the third quarter ended December 31, 2022.

Key Points: 
  • In January 2023, Reunion completed its Phase 1 interim data analysis, which showed that RE104 was safe and well tolerated, with no serious or severe adverse events.
  • Exploring further doses with the two additional planned cohorts will provide Reunion with valuable data to inform selection of a recommended Phase 2 dose.
  • Reunion will conduct a conference call and webcast to discuss its results on February 14, 2023, at 8:30 a.m.
  • A live webcast of the conference call can be accessed via the “Events and Presentations” section of the Reunion investor relations website here .

Pioneering Delix Therapeutics Study Published in 'Science' Elucidates the Mechanism of Psychedelic-Induced Neuroplasticity

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Thursday, February 16, 2023
Chemical & Engineering News, Brain, Medicinal chemistry, Journal, Delix Therapeutics, Frontiers, Therapy, Serotonin, Psychedelic drug, Engineering News-Record, PTSD, European Journal of Medicinal Chemistry, Drug development, Patient, Depression, Schizophrenia, University, Olson, Behavior, Research, Cell, Posterior cortical atrophy, Knowledge, Deficit spending, Central nervous system, Selective serotonin reuptake inhibitor, Doctor of Philosophy, Pharmaceutical industry, Nature, Ramipril, Science, Psychiatry

BOSTON, Feb. 16, 2023 /PRNewswire/ -- Delix Therapeutics (the "Company"), a neuroscience company developing novel disease-modifying, neuroplasticity-promoting therapeutics for psychiatric and neurological conditions, shared the findings of a new study published today in Science. The groundbreaking paper, authored by Delix Co-founder and Chief Innovation Officer David E. Olson, PhD, reveals the mechanism that causes serotonin and psychoplastogens to activate the 5-HT2A receptor in different ways.

Key Points: 
  • BOSTON, Feb. 16, 2023 /PRNewswire/ -- Delix Therapeutics (the "Company"), a neuroscience company developing novel disease-modifying, neuroplasticity-promoting therapeutics for psychiatric and neurological conditions, shared the findings of a new study published today in Science.
  • The study uncovers the fact that intracellular 5-HT2A receptors mediate the psychoplastogenic effects of psychedelics.
  • As serotonin cannot activate this population of receptors, the study might explain why serotonin-based therapeutics - such as SSRIs, commonly prescribed antidepressants – have different effects than psychedelics and other psychoplastogenic therapeutics.
  • The Delix team continues to advance its unique scientific and talent advantage at the forefront of central nervous system drug development," added Mark Rus, CEO of Delix Therapeutics.

Ehave Provides Progress Update on its HPPD Study with University of Melbourne

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Thursday, February 2, 2023
Mental health, Diagnosis, MDMA, Mushroom, Biomarker, Migraine, Risk, Student, University, Hallucinogen persisting perception disorder, LSD, Research, Depression, Anxiety, Incidence, Health care, OTC Markets Group, HPPD, Visual snow, University of Melbourne, Selective serotonin reuptake inhibitor, Pharmaceutical industry, Cannabis

The HPPD study with the University of Melbourne marks one of several strategic transactions that Ehave has completed in recent months to support its research and development pipeline of active psychedelic-based and potential clinical programs for mental health.

Key Points: 
  • The HPPD study with the University of Melbourne marks one of several strategic transactions that Ehave has completed in recent months to support its research and development pipeline of active psychedelic-based and potential clinical programs for mental health.
  • HPPD, also known as a "bad trip," causes individuals to have recurring visual disturbances recalling only the part of the psychedelic experience that involved visions.
  • The data from phase one of our testing process is from the University of Melbourne undergraduate sample, not the HPPD community.
  • We believe determining the cause of HPPD and finding a possible cure will help us better understand these molecules as a whole."

Small Pharma Reports Fiscal Third Quarter 2023 Highlights

Retrieved on: 
Wednesday, January 25, 2023
SEDAR, Safety, PD, TSX Venture Exchange, Participation, University College London, MDD, Cognition, DMT, Functional magnetic resonance imaging, Pharmacokinetics, Service, MADRS, IM, Intellectual property, Magnetic resonance, Agreement, Patient, Loss, Patent, PK, Grammatical mood, GBP, Major depressive disorder, Knowledge, Selective serotonin reuptake inhibitor, Substituted tryptamine, Brain, USD, Pharmaceutical industry, Medical device

LONDON, Jan. 25, 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, has today published its financial results for the three and nine months ended November 30, 2022. A full copy of the financial results can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars.

Key Points: 
  • LONDON, Jan. 25, 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, has today published its financial results for the three and nine months ended November 30, 2022.
  • Preparations for Phase IIb international multi-site clinical trial of SPL026 in MDD continues, with anticipated initiation in H1 2023.
  • First patient dosed in January 2023 in the Phase I study exploring intramuscular (“IM”) administration of SPL026.
  • In the third fiscal quarter we made strong progress across our clinical trials, with two new SPL026 studies now underway and patient screening initiated in our first in-human trial with SPL028.

Mindbloom partners with This is Jane Project to offer affordable at-home ketamine therapy to trauma survivors

Retrieved on: 
Monday, January 16, 2023
Cleveland Clinic, Education, Depression, The Plain Jane Project, Anxiety, Trauma, Partnership, Organization, MAPS, Woman, Cleveland, Journal, Journal of Affective Disorders, Houston Methodist Hospital, Selective serotonin reuptake inhibitor, Survivor, UCSF, Pleasure, NYU, Pharmaceutical industry, Medicine

Through this partnership, This is Jane Project’s members will be able to access Mindbloom’s at-home ketamine therapy programs at a substantial discount.

Key Points: 
  • Through this partnership, This is Jane Project’s members will be able to access Mindbloom’s at-home ketamine therapy programs at a substantial discount.
  • In addition to discounted treatment, Mindbloom is also providing education on ketamine therapy to members of the organization.
  • In December, Mindbloom announced a partnership with Kennedy Care, a leader in home care services across Michigan and Northern Ohio, to offer at-home ketamine therapy as an employee benefit.
  • "This is highly personal for me, and I’m incredibly proud that we’re partnering with This is Jane Project to increase access to the transformative and healing power of at-home ketamine therapy for survivors of trauma."

Reunion Neuroscience Inc. Provides 2023 Corporate Update

Retrieved on: 
Wednesday, January 4, 2023
Psilocybin, Tolerability, Selective serotonin reuptake inhibitor, Anxiety, ACS, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Drug discovery, Hope, TSX, Depression, Mother, Interim analysis, Reunion, Patient, Pharmacodynamics, FDA, PPD, IND, Woman, Pharmaceutical industry, Safety

TORONTO, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Reunion Neuroscience Inc. (NASDAQ: REUN, TSX: REUN) (“Reunion” or “the Company”), a biopharmaceutical company committed to developing innovative and patented therapeutic solutions for underserved mental health conditions, today provided a corporate update for 2023 as it continues to advance its lead asset, RE104, through clinical development. As a proprietary, novel serotonergic psychedelic compound designed uniquely as a 4-OH-DiPT prodrug, RE104 is in development as a potential fast-acting, durable treatment for patients suffering from postpartum depression (PPD) and other mental health conditions.

Key Points: 
  • Reunion plans to report a preplanned interim analysis on 32 subjects from its first-in-human Phase 1 trial for RE104 in Q1 2023.
  • (2) What is the onset and duration of the psychoactive experience and pharmacokinetic profile of RE104 over a range of dose levels?
  • The Company plans to share detailed results from its Phase 1 study at a major medical meeting in the first half of 2023.
  • Once the PPD Phase 2 program is in progress, Reunion plans to share its continued RE104 development strategy in pursuit of treating additional indications.

Mindbloom Announces Rollout of Ketamine Telehealth Employee Benefits Program with Kennedy Care, 15Five

Retrieved on: 
Wednesday, December 14, 2022
Cleveland Clinic, Depression, UCSF, Journal of Affective Disorders, Cleveland, Journal, MAPS, NYU, Selective serotonin reuptake inhibitor, Houston Methodist Hospital, Ageing, Partnership, Mental health, Anxiety, Pharmaceutical industry, Medicine

As of November, Kennedy Care employees can access at-home ketamine therapy through Mindbloom.

Key Points: 
  • As of November, Kennedy Care employees can access at-home ketamine therapy through Mindbloom.
  • In November, 15Five , a pioneer in HR talent management technology, became the first company to offer the benefit.
  • Mindbloom has offered ketamine therapy as a benefit for its own employees since launching in 2019.
  • Founded by three-time entrepreneur Dylan Beynon, Mindbloom aims to address the mental health crisis through at-home ketamine therapy.

Ascension Healthcare Announces Positive Data from Phase 2 Study of SelectAte in Severe Haemophilia A Patients with inhibitors

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Monday, December 12, 2022
Haemophilia, Bleeding, Prevalence, Antibody, FDA, Factor VIII, University College London, VIII, Osteoarthritis, Coronavirus Scientific Advisory Board (Turkey), Fibrinolysis, Haemophilia A, History, Risk, Male, Selective serotonin reuptake inhibitor, Ascension, Patient, Pharmaceutical industry

SelectAte is a proprietary pre-mixed combination of a recombinant factor VIII clotting protein and PEGylated liposomes (PEGLip), co-injected intravenously.

Key Points: 
  • SelectAte is a proprietary pre-mixed combination of a recombinant factor VIII clotting protein and PEGylated liposomes (PEGLip), co-injected intravenously.
  • These results were achieved in both non-inhibitor patients and also those that were both inhibitor prone and presenting with low levels of inhibitors.
  • SelectAte is being developed to treat severe HA patients who have developed inhibitors (neutralising antibodies) to FVIII.
  • Approximately 30% of severe HA patients develop inhibitors to prophylactic FVIII replacement therapy, rendering such therapy ineffective.

Alto Neuroscience Presents New Data Leveraging EEG and Machine Learning to Predict Individual Response to Antidepressants at the 61st Annual Meeting of the American College of Neuropsychopharmacology

Retrieved on: 
Thursday, December 8, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Mental Health, Clinical Trials, American College, RCT, SSRI, Genetics, Biomarker, Patient, Biology, PTSD, Disease, FDA, Neuroscience, Mental health, American College of Neuropsychopharmacology, EEG, Failure, Brain, Hamilton Rating Scale for Depression, Depression, Machine learning, Cognition, MDD, Medical device, Pharmaceutical industry, Risk management, Selective serotonin reuptake inhibitor

The data we presented at ACNP further validate our work and exemplify the future of precision psychiatry in changing the mental health treatment landscape.

Key Points: 
  • The data we presented at ACNP further validate our work and exemplify the future of precision psychiatry in changing the mental health treatment landscape.
  • Alto developed and validated a machine learning model for predicting individual response to SSRIs using 19-channel resting-state electroencephalography (rsEEG) data from two MDD clinical trials (total N= 346).
  • Data from 93 MDD patients in the SSRI arm of an open-label clinical trial were used for model development.
  • These results demonstrate that robust prediction of individual response to antidepressants can be achieved leveraging EEG and machine learning in a specific and reproducible manner developed by Alto Neuroscience.