5-MeO-DMT

Beckley Psytech announces positive initial data from Phase IIa study of novel 5-MeO-DMT formulation BPL-003 for Treatment Resistant Depression

Retrieved on: 
Wednesday, March 27, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Other Health, Depression, Atypical depression, Data analysis, MDD, Patient, Beckley Foundation, DSM-IV codes, TRD, Treatment, Drug development, Safety, Phase, FDA, 5-MeO-DMT, Pharmaceutical industry

95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .

Key Points: 
  • 95% of events were mild or moderate, and no serious adverse events were reported which is broadly consistent with Phase I findings .
  • Acute effects were resolved and patients were deemed dischargeable within an average time of less than 2 hours.
  • Our single dose treatment model enables a short treatment duration which positions BPL-003 as a potentially exciting and scalable treatment opportunity.
  • The company’s lead compound, BPL-003, is a novel, synthetic 5-MeO-DMT benzoate salt candidate currently under investigation for the treatment of Treatment Resistant Depression (TRD) and Alcohol Use Disorder (AUD).

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.

Lusaris Therapeutics Launches with $60 Million Series A Financing to Redefine the Treatment of Severe Neuropsychiatric and Neurological Disorders

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Wednesday, November 2, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, CMC, Migraine, Cluster headache, Liver, Water, Catalent, TRD, Board, Partner, Director, Physician, Zydis, 5-MeO-DMT, Interim, Regulatory affairs, RA, Technology, Metabolism, Therapy, Master of Philosophy, Patient, 5-Methoxy-N,N-diisopropyltryptamine, Tongue, Depression, CPA, Enzyme, Pharmaceutical industry, Discovery

Lusaris Therapeutics, a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological conditions, launched today with a $60 million Series A financing.

Key Points: 
  • Lusaris Therapeutics, a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological conditions, launched today with a $60 million Series A financing.
  • Psychoplastogens have emerged as a promising treatment approach supported by compelling scientific evidence in patients with TRD and other severe neuropsychiatric conditions.
  • Lusaris plans to develop LSR-1019 for the treatment of TRD and additional severe neuropsychiatric disorders.
  • Lusaris is a biotechnology company advancing next-generation serotonergic neuroplastogen therapeutics to treat severe neuropsychiatric and neurological disorders.

Small Pharma Reports Fiscal Second Quarter 2023 Highlights

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Friday, October 14, 2022
Selective serotonin reuptake inhibitor, Medicines and Healthcare products Regulatory Agency, Loss, MHRA, DMT, European College of Neuropsychopharmacology, MDD, Patient, First United States Army, Intellectual property, Composition of matter, Biotechnology, Depression, IV, GBP, Foreign, Commonwealth and Development Office, SSRI, Data, Company, Pharmacokinetics, IP, CTA, Patent, Safety, Genta (company), Psilocybin, GLOBE, 5-MeO-DMT, SEDAR, Pharmaceutical industry, Online gambling, Phase

LONDON, Oct. 14, 2022 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-acting psychedelic-assisted therapies for mental health conditions, has today published its financial results for the three and six months ended August 31, 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: 
  • The trial requires patient follow-up for 12 weeks following their second dose, which is on track to be completed by the end of 2022.
  • Small Pharma is a biotechnology company progressing a pipeline of short-acting psychedelic assisted therapies for the treatment of mental health conditions.
  • Small Pharmas lead candidate, SPL026, is a proprietary synthetic formulation of DMT.
  • In addition, Small Pharma has a pipeline of proprietary preclinical assets in development.

Mindset Pharma Announces Development of Novel, Optimized, Intranasal Formulation

Retrieved on: 
Wednesday, June 29, 2022
Patient, CEO, Otsuka Pharmaceutical, PCT, FSE, Brain, GLOBE, MSET, CNS, CSF, Central nervous system, Company, 5-MeO-DMT, CSE, Plasma, CSO, Development, Pharmacokinetics, POC, Therapy, NCE, Technology, Patent, Central nervous system disease, Drug discovery, Pharmaceutical industry, Mindset

Mindsets novel intranasal formulation technology leverages its unique platform technology, a common feature of several of Mindsets leading psychedelic drug candidates, altering the pharmacokinetics profile of the active pharmaceutical ingredient.

Key Points: 
  • Mindsets novel intranasal formulation technology leverages its unique platform technology, a common feature of several of Mindsets leading psychedelic drug candidates, altering the pharmacokinetics profile of the active pharmaceutical ingredient.
  • The proof of concept (PoC) of this novel formulation demonstrates improved CNS penetration compared to standard formulations of 5-MeO-DMT.
  • Data also demonstrates increased CSF exposure relative to plasma in comparison to a standard formulation by a factor of approximately 3.
  • Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs.

Biomind Labs Receives Approval for a Second Phase II Clinical Trial for Treatment-resistant Depression

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Wednesday, March 9, 2022
Mental Health, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Molecule, Safety, Health Canada, Protocol, OTC, Compliance, DMT, Company, Drug, Research, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Failure, Phase, Depression, Nature, News, Psychiatry, 5-MeO-DMT, Regulation, NEO, Forward-looking statement, Patient, Tryptamine, Corona Labs Inc., FSE, Disease, Food, Legislation, CEO, Income, Phrase, Mescaline, Pharmaceutical industry, Risk management, COVID-19

Just a few months ago, we announced the approval of our first Phase II clinical trial with an intramuscular formulation of DMT for treatment-resistant depression.

Key Points: 
  • Just a few months ago, we announced the approval of our first Phase II clinical trial with an intramuscular formulation of DMT for treatment-resistant depression.
  • Today with great enthusiasm we announce the IRBs approval of our second Phase II clinical trial with an inhaled formulation of DMT, which will may allow us to identify the most effective method of administration for our DMT candidate in patients with depression, commented Alejandro Antalich, CEO of Biomind Labs.
  • In this second Phase II clinical trial, the Company will test a new approach of psychedelic therapies, a psychiatry intervention-based model, allowing a rapid and feasible merge of fast-acting psychedelic medicines into clinical practices already in existence.
  • This second Phase II clinical trial is scheduled to begin in the upcoming weeks.

Cybin Inc. Reports Third Quarter Financial Results and Recent Business Highlights

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Thursday, February 10, 2022
Health, Biotechnology, Growth, University of Washington Department of Bioengineering, U.S. Securities and Exchange Commission, Safety, NYSE, COVID, Risk, Inc., Disease, Food, NEO, Business, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Northwell Health, Institutional review board, Lists of diseases, Research, DMT, Company, Therapy, 5-MeO-DMT, Calendar, Science, News, Lenox Hill Hospital, Patent, Cerebral cortex, Time, Clinical trial, MDD, Patient, NYSE American, EDGAR, Engineering, IRB, Nature, COVID-19, Medicines and Healthcare products Regulatory Agency, Health Canada, University, Event, Hemodynamics, Psilocybin, Forward-looking statement, Pharmaceutical industry, Cryptocurrency

Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics, today reported unaudited financial results for its third quarter ended December 31, 2021.

Key Points: 
  • Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics, today reported unaudited financial results for its third quarter ended December 31, 2021.
  • Recent Business and Pipeline Highlights:
    Continued to advance CYB003 towards clinical development for the potential treatment of major depressive disorder (MDD) and alcohol use disorder (AUD).
  • Cybin plans to submit regulatory applications in the second quarter of CY2022, followed by initiation of the Phase 1/2a trial in mid-CY2022.
  • Cybin plans to submit a regulatory application in the second quarter of CY2022 for a pilot study of CYB004, which is expected to begin in the third quarter of CY2022.

Psygen Receives Dealer's Licence from Health Canada

Retrieved on: 
Monday, January 17, 2022
Forward-looking statement, Patient, DMT, News, Psilocybin, Person, SAP, MDMA, Health Canada, 5-MeO-DMT, Psychotherapy, Ibogaine, API, GMP, Mescaline, Industry, LSD, 5-Methoxy-N,N-diisopropyltryptamine, Drug development, Sale, Food, Compliance, Substance-related disorder, Pharmaceutical industry, Fine chemical

Global Reach for Canada's Only Dedicated Manufacturer of Synthetic Psychedelics

Key Points: 
  • Psygen has over twenty supply agreements in place for psilocybin, DMT, ibogaine, 5-MeO-DMT, MDMA and LSD to be fulfilled globally from production at the Psygen facility.
  • Psygen also provided Health Canada with consent to be identified on a public list as a licensed dealer able to provide GMP psilocybin for use in patients through Canada's special access program (the "SAP").
  • On January 5, 2022, the Food and Drug Regulations (Canada) were amended to allow access to restricted drugs such as psilocybin and MDMA through the SAP.
  • "A primary application for psychedelics is to support psychotherapy for treatment of mental health conditions.

Mindset Pharma Recaps 2021 Milestones and Highlights

Retrieved on: 
Thursday, December 30, 2021
SAB, DMT, Drug discovery, PCT, United States Air Force Scientific Advisory Board, Leadership, MSET, GLOBE, Senior, CEO, DRS, 5-MeO-DMT, Preclinical development, FSE, Psilocybin, IND, CSE, Technology, Pharmaceutical industry, Innovation, Mindset

TORONTO, Dec. 30, 2021 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company"), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today provided a recap of its 2021 milestones and highlights.

Key Points: 
  • TORONTO, Dec. 30, 2021 (GLOBE NEWSWIRE) -- Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company"), a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet medical needs, today provided a recap of its 2021 milestones and highlights.
  • In 2021, we made significant progress in building our portfolio of next-generation psychedelic compounds showing improved preclinical safety and efficacy of 5-MeO-DMT and psilocybin-based therapies, said James Lanthier, CEO of Mindset.
  • Growing Library of Novel Compounds: Synthesized over 100 novel compounds in more than 500 in vitro and in vivo studies.
  • Developed First-in-Class Benchmarking: Under the Cooperative Psychedelics Evaluation Platform (COPE) program, Mindset and its partner, InterVivo Solutions, continued to develop first-in-class benchmarking data across first-generation psychedelic drugs.

SES, MDDIAI RK, RCSC, and AsiaNetCom Launch Demo Project to Test High-Speed Connectivity via O3b Satellite Constellation in Remote Villages of Kazakhstan

Retrieved on: 
Friday, November 19, 2021
Networks, Internet, Satellite, Technology, Telecommunications, Constellation, RCSC, MEO, Ministry of Digital Development, Innovation and Aerospace Industry (Kazakhstan), Internet, Technology, MPower, Population, SES, Internet access, Nur-Sultan, Education, Solution, Ministry, O3b, 5-MeO-DMT, Digital divide, Board, JSC, Science, Multimedia, Quality of life, Communications satellite, SES, RCSC, SES, RCSC

During the demonstration, the companies have achieved 380Mbps downlink and 120Mbps uplink via SESs O3b satellite constellation, the highest speed ever recorded in Kazakhstan via satellite.

Key Points: 
  • During the demonstration, the companies have achieved 380Mbps downlink and 120Mbps uplink via SESs O3b satellite constellation, the highest speed ever recorded in Kazakhstan via satellite.
  • However, there are still remote villages where it is impossible to deliver a network using radio relay communications or through cable connection.
  • In some cases, the use of terrestrial networks is economically impractical, and we are considering the opportunities to implement innovative satellite technology to provide high-speed connectivity in those remote villages.
  • In addition, it will deliver significantly higher speeds flexibly, catering to the increasing needs from governments, enterprises and mobile operators.