Treatment-resistant depression

Head-to-head Trial of Prolonged-Release Oral Ketamine Formulation, KET01, and Intranasal SPRAVATO®, Finds Less Incidence of Dissociation or Cardiovascular Effects with Oral Treatment, at doses used for Treatment-Resistant Depression

Retrieved on: 
Monday, November 13, 2023
Safety, Incidence, Grammatical mood, Dissociative, Plasma, Headache, Patient, Male, FDA, Treatment-resistant depression, MADRS, TRD, Czech Republic, Esketamine, Ketamine, Dizziness, Pharmaceutical industry, Dietary supplement, Boston

MUNICH, Germany, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ketabon GmbH (“Ketabon” or “the Company”), a joint venture between HMNC Brain Health and Develco Pharma, announced today favorable results from its head-to-head trial with KET01, the Company’s proprietary lead asset, versus SPRAVATO®, the FDA-approved intranasal spray for patients with Treatment-Resistant Depression (TRD). KET01 is an IP protected oral prolonged-release formulation of ketamine and is being studied in patients with TRD. Due to its unique metabolite profile, the incidence of dissociation with KET01 was very low and statistically significantly lower relative to SPRAVATO®, pointing to a clinically meaningful difference, which could offer the potential for a safe at-home unsupervised administration. During the summer Ketabon also released data from its Phase 2 KET01-02 trial with KET01, which demonstrated rapid and durable improvements in depressive symptoms in TRD. 

Key Points: 
  • KET01 is an IP protected oral prolonged-release formulation of ketamine and is being studied in patients with TRD.
  • During the summer Ketabon also released data from its Phase 2 KET01-02 trial with KET01, which demonstrated rapid and durable improvements in depressive symptoms in TRD.
  • Only minimal signs of dissociative symptoms were detected by the CADSS scale, and no changes in cardiovascular parameters were detected.
  • “Data continues to suggest rapid and clinically relevant reduction of depressive symptoms after oral treatment with 240 mg/day of KET01.

INmune Bio Inc. Announces Third Quarter 2023 Results and Provides Business Update

Retrieved on: 
Wednesday, November 1, 2023
Research, AD, Food, Health care, Biomarker, ATCC, Macrophage, World Intellectual Property Organization, Data, White matter, Phase, MHRA, MRI, MDS, CELL, Hereditary leiomyomatosis and renal cell cancer syndrome, Prostate cancer, Dementia, China International Search and Rescue Team, ATCC (company), Phagocytosis, EEG, Cancer, Patient, MS, BOCA, Human, Neurodegenerative disease, Conference, CTA, Patent Cooperation Treaty, AAIC, PCT, NK, Brain, Remyelination, Grey, AML, Carcinoma, FDA, IND, Medication, CNS, Treatment-resistant depression, Drug development, Pharmacotherapy, Neuroinflammation, WIPO, Cross, Cognition, Vaccine, Pharmaceutical industry, Medical imaging, Cryptocurrency, Health, Immunotherapy, Disease

BOCA RATON, Fla., Nov. 01, 2023 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended September 30, 2023 and provides a business update.

Key Points: 
  • BOCA RATON, Fla., Nov. 01, 2023 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today announces its financial results for the quarter ended September 30, 2023 and provides a business update.
  • Recruitment of the trial is increasing and the company anticipates results of the Phase II program towards the end of 2024.
  • Other expense was approximately $0.0 million for the quarter ended September 30, 2023, compared to approximately $0.3 million during the quarter ended September 30, 2022.
  • Please ask for the INmune Bio Third Quarter Conference Call when reaching an operator.

HMNC Brain Health Appoints Evan Papanastasiou as VP Clinical Development

Retrieved on: 
Monday, May 8, 2023
Lundbeck, PhD-MBA, MBA, Research, DSM-IV codes, Doctor of Philosophy, CNS, Boehringer Ingelheim, MDD, Patient, MD, Treatment-resistant depression, American College, TRD, Mental health, Major depressive disorder, Pharmaceutical industry, Nursing, Psychosis

MUNICH, Germany, May 08, 2023 (GLOBE NEWSWIRE) -- HMNC Brain Health (‘‘HMNC’’ or the ‘‘Company’’), a global clinical-stage biopharmaceutical company, pioneering the development of personalized therapies powered by predictive companion diagnostics, announced today the appointment of Dr. Evan Papanastasiou, MD MSc PhD MBA, as VP Clinical Development, to lead pre-clinical and clinical programs and support new development opportunities at the Company.

Key Points: 
  • MUNICH, Germany, May 08, 2023 (GLOBE NEWSWIRE) -- HMNC Brain Health (‘‘HMNC’’ or the ‘‘Company’’), a global clinical-stage biopharmaceutical company, pioneering the development of personalized therapies powered by predictive companion diagnostics, announced today the appointment of Dr. Evan Papanastasiou, MD MSc PhD MBA, as VP Clinical Development, to lead pre-clinical and clinical programs and support new development opportunities at the Company.
  • In his new role, Dr. Papanastasiou will be responsible for the strategy, direction, and execution of the Company’s clinical development plans, such as progressing HMNC Brain Health’s Ketabon program towards the pathway of commercialization.
  • Most recently, Dr. Papanastasiou served as the Global Clinical Program Leader at Boehringer Ingelheim, where he was responsible for the ongoing refinement of clinical development pathways; coordination of scientific & cross-functional teams in a matrix environment.
  • “I am looking forward to joining the clinical leadership team at HMNC Brain Health as they are disruptors in the mental health industry and personalizing treatments that benefit individual patients rather than serving the one-size-fits-all current standard of mental health treatment.

HMNC Brain Health and Develco Pharma Announce Last Patient Being Randomized in Oral Prolonged-Release Ketamine (KET01) Trial for Treatment-Resistant Depression

Retrieved on: 
Tuesday, March 28, 2023
Ketamine, MADRS, Patient, Treatment-resistant depression, TRD, Psychiatry, Safety, Pharmaceutical industry

Topline data from the Phase 2 trial, which is investigating efficacy, safety, and tolerability, is expected to be reported soon after the last study visit.

Key Points: 
  • Topline data from the Phase 2 trial, which is investigating efficacy, safety, and tolerability, is expected to be reported soon after the last study visit.
  • Enrollment in the Phase 2 trial commenced in June 2022 and 122 patients with treatment-resistant depression (TRD) have now been randomized at 29 clinical sites.
  • Patients were selected based on current major depressive episodes not responding to a minimum of two standard antidepressants.
  • The trial design enables the assessment of the oral prolonged-release formulation of ketamine that could sustainably transform the therapy of treatment-resistant depression, compared with the currently applied intravenous and intranasal ketamine and esketamine therapies.

5-MeO-DMT Education and Training Company F.I.V.E Announces protocols and Clinician Training for Trials and Research

Retrieved on: 
Wednesday, February 22, 2023
Marketing, Consultant, Tandava, DSM-IV codes, Treatment-resistant depression, Risk, Traction, Research, Patient safety, Depression, Education, MAPS, Pharmaceutical industry, Nursing

Tepoztlan, Mexico--(Newsfile Corp. - February 22, 2023) - F.I.V.E , a company dedicated to education and training for using 5-MeO-DMT, is excited to announce the creation of protocols and clinician training for clinical trials and research.

Key Points: 
  • Tepoztlan, Mexico--(Newsfile Corp. - February 22, 2023) - F.I.V.E , a company dedicated to education and training for using 5-MeO-DMT, is excited to announce the creation of protocols and clinician training for clinical trials and research.
  • The company draws data from its brother company Tandava Retreats, the world's first center devoted to the safe and effective use of 5-MeO-DMT.
  • As psychedelic research continues gaining traction and mainstream acceptance, many companies have taken an interest in developing and marketing new products.
  • "We are excited to work with other leaders in the space to help them achieve their desired results for clinical trials and research," said Victoria Wueschner, a member of the F.I.V.E team.

Australia Allows Prescription of MDMA and Psilocybin in Groundbreaking Regulatory Change

Retrieved on: 
Friday, February 3, 2023
Psilocybin, MDMA, PTSD, NHMRC, National Health, National Health and Medical Research Council, Treatment-resistant depression, Medical Research Council, Patient, Psychedelic drug, CSE, API, TGA, GMP, Depression, Pharmaceutical industry

VANCOUVER, British Columbia, Feb. 03, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA) applauds the Australian Therapeutic Goods Administration (TGA) in allowing for specially-licensed psychiatrists to prescribe MDMA and Psilocybin .

Key Points: 
  • VANCOUVER, British Columbia, Feb. 03, 2023 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla”)(CSE: MDMA) applauds the Australian Therapeutic Goods Administration (TGA) in allowing for specially-licensed psychiatrists to prescribe MDMA and Psilocybin .
  • PharmAla is the only publicly-traded company currently manufacturing and exporting clinical-grade MDMA, and the only entity in the world that offers its customers GMP MDMA and GMP Psilocybin.
  • “This is a critically important announcement by the TGA, allowing for the direct prescription and treatment of patients with PTSD and Treatment-Resistant Depression with Psychedelic molecules,” said Nick Kadysh, CEO of PharmAla.
  • “The TGA decision absolutely sets a new global standard for treatment with molecules like MDMA and Psilocybin,” said Dr. Shane Morris, COO of PharmAla Biotech.

HMNC Brain Health Raises EUR 14.3 million to Advance Precision Psychiatry Therapies

Retrieved on: 
Thursday, October 20, 2022
CRHR1, Time, Deutsche Bank, MDD, Patient, Depression, Program, Brain, Entrepreneurship, Mental health, Precision medicine, Sport, VC, Company, Ketamine, Health, Board, CEO, Mental, Safety, Real Madrid CF, Anxiety, GLOBE, Clinical trial, TRD, Director, Lists of diseases, Psychiatry, Treatment-resistant depression, Major depressive disorder, Security (finance), Pharmaceutical industry

MUNICH, Germany, Oct. 20, 2022 (GLOBE NEWSWIRE) -- HMNC Brain Health (“HMNC'' or the “Company”), a clinical stage biopharma company pioneering precision psychiatry, today announced it has raised an additional EUR 14.3 million in a funding series, bringing the total capital raised to date to EUR 42.3 million.

Key Points: 
  • With this funding, we will advance the development of our personalized therapies to combat severe, unmet mental health challenges around the world.
  • That's why I have decided to support HMNC as an investor and be part of the precision psychiatry revolution.
  • HMNC Brain Health expects to complete a second closing of this round by end of March 2023.
  • HMNC Brain Health (HMNC Holding GmbH) is a clinical stage precision psychiatry biopharma company, pioneering the development of personalized therapies, powered by its AI platform and predictive companion diagnostics suite, bringing substantial therapeutic benefit to select patient populations suffering from mental health disorders.

Freedom Biosciences Emerges from Stealth with $10.5 Million Seed Financing to Develop Next-Generation Ketamine and Psychedelic-based Mental Health Treatments

Retrieved on: 
Tuesday, August 23, 2022
Mental Health, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Psychedelic drug, MDMA, Research, Human, Division, NYSE, Psilocybin, View, Pfizer, Center for Drug Evaluation and Research, Program, Psychiatry, Hope, DMT, Department, Behavior, Ketamine, Depression, Coronavirus Scientific Advisory Board (Turkey), Center, Lists of diseases, FDA, Yale University, Therapy, History, Selective serotonin reuptake inhibitor, List of life sciences, Drug development, LSD, Imperial College London, Treatment-resistant depression, Patient, Pharmaceutical industry

Freedom Biosciences, a clinical-stage biotechnology platform developing next-generation viable and efficacious ketamine and psychedelic therapeutics, today emerged from stealth with $10.5 million in seed financing.

Key Points: 
  • Freedom Biosciences, a clinical-stage biotechnology platform developing next-generation viable and efficacious ketamine and psychedelic therapeutics, today emerged from stealth with $10.5 million in seed financing.
  • The new financing will help the company advance its current lead ketamine program as well as further multiple additional exploratory programs.
  • Burkitbayeva now serves as Freedom Biosciences CEO, while Dr. Krystal serves as its Chief Scientific Advisor.
  • Freedom Biosciences launched from stealth in 2022 and is backed by MBX Capital, Village Global and PsyMed Ventures, among others.

Maximilian Doebler Appointed Chief Business Officer of HMNC Brain Health

Retrieved on: 
Monday, August 22, 2022
Partnership, Lists of diseases, VC, Business development, Standard of care, Head, KPMG, Ketamine, Master of Laws, Psychiatry, GLOBE, Company, TRD, General practice, MDD, Knowledge, Major depressive disorder, Industry, Treatment-resistant depression, Patient, Pharmaceutical industry

MUNICH, Germany, Aug. 22, 2022 (GLOBE NEWSWIRE) -- HMNC Brain Health (HMNC'' or the Company), a clinical stage precision psychiatry biopharma company, pioneering the development of personalized therapies powered by predictive companion diagnostics, announced today the appointment of Dr. Maximilian Doebler, previous Head of Business Development & Licensing of HMNC Brain Health, as Chief Business Officer.

Key Points: 
  • MUNICH, Germany, Aug. 22, 2022 (GLOBE NEWSWIRE) -- HMNC Brain Health (HMNC'' or the Company), a clinical stage precision psychiatry biopharma company, pioneering the development of personalized therapies powered by predictive companion diagnostics, announced today the appointment of Dr. Maximilian Doebler, previous Head of Business Development & Licensing of HMNC Brain Health, as Chief Business Officer.
  • He will also be the lead in developing strategies for potential deals that will allow HMNC Brain Health to fulfill its mission and build value for patients and shareholders, among other roles.
  • Dr. Doeblers extensive knowledge and experience in corporate development will play a crucial role in helping HMNC advance our unique pipeline for targeting both major depressive disorder and treatment-resistant depression, said Dr. Hans Eriksson, Chief Medical Officer at HMNC Brain Health.
  • Most recently, Dr. Doebler served as Head of Business Development & Licensing of HMNC Brain Health, as well as Head of Operations.

HMNC Brain Health to Participate in the H.C. Wainwright 1st Annual Mental Health Conference: Neuropsychiatry, Psychedelics, and Beyond on June 27, 2022

Retrieved on: 
Thursday, June 23, 2022
Psychiatry, VC, Company, TRD, Brain, Treatment-resistant depression, Conference, GLOBE, MDD, Pharmaceutical industry

MUNICH, Germany, June 23, 2022 (GLOBE NEWSWIRE) -- HMNC Brain Health (HMNC or the Company), a global clinical stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, announced today that HMNCs management team will present virtually at the H.C. Wainwright 1st Annual Mental Health Conference taking place on June 27, 2022.

Key Points: 
  • MUNICH, Germany, June 23, 2022 (GLOBE NEWSWIRE) -- HMNC Brain Health (HMNC or the Company), a global clinical stage biopharmaceutical company pioneering the development of personalized therapies in psychiatry, announced today that HMNCs management team will present virtually at the H.C. Wainwright 1st Annual Mental Health Conference taking place on June 27, 2022.
  • A recording of HMNCs presentation will be available beginning Monday, June 27 at 7:00 a.m. Eastern Time.
  • HMNC Brain Healths management team will be available for one-on-one meetings throughout the conference.
  • HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to far shorter treatments and higher remission rates.