TRD

atai Life Sciences Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate and Clinical Highlights

Retrieved on: 
Thursday, March 28, 2024

“In 2023, we demonstrated our continued commitment to transforming mental health care for those most in need.

Key Points: 
  • “In 2023, we demonstrated our continued commitment to transforming mental health care for those most in need.
  • In November 2023, atai acquired all remaining outstanding shares of its subsidiary, DemeRx IB, Inc., streamlining clinical, general and administrative operations.
  • atai realized operational efficiencies by simplifying and optimizing its organizational structure in line with its revised business and pipeline priorities.
  • In August 2023, the Phase 1 study results demonstrated that 9 mg/kg of oral ibogaine leads to robust psychedelic experiences.

Compass Pathways Board Chair and Co-Founder George Goldsmith and Co-Founder Ekaterina Malievskaia Step Down from Board of Directors

Retrieved on: 
Thursday, March 28, 2024

David Norton, lead independent director on the Compass board of directors, will become interim chair.

Key Points: 
  • David Norton, lead independent director on the Compass board of directors, will become interim chair.
  • Compass is running a global search for a permanent board chair, focused on recruiting a leader with a strong background in the biotechnology sector and broad strategic experience across the product lifecycle.
  • “When we started Compass eight years ago, we could not have imagined how the company would grow and mature,” said George Goldsmith, outgoing board chair of Compass Pathways.
  • He has been a member of the Compass board of directors since 2018, serving as lead independent director.

atai Life Sciences Announces Positive Initial Results from Beckley Psytech’s Phase 2a Open Label Study of BPL-003 (Intranasal 5-MeO-DMT) in Treatment Resistant Depression

Retrieved on: 
Wednesday, March 27, 2024

The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants.

Key Points: 
  • The open-label Phase 2a study investigated the safety, tolerability and efficacy of a single 10mg dose of BPL-003 alongside psychological support in patients with moderate-to-severe TRD who were not taking concomitant antidepressants.
  • Patients were followed for 12 weeks post-dosing, with assessments conducted at multiple points throughout the study.
  • Initial analysis showed that a single dose of BPL-003 induced a rapid antidepressant response2 in 55% of patients on the day after dosing.
  • The positive data from the Phase 2a study is highly encouraging as we await the results of the larger Phase 2b study anticipated later this year.

Denovo Biopharma Announces a Major Breakthrough in Treatment‑Resistant Depression with Precision Medicine

Retrieved on: 
Tuesday, April 9, 2024

Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative drugs, today announced positive results for its biomarker‑guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD).

Key Points: 
  • Denovo Biopharma LLC (Denovo), a pioneer in applying precision medicine to the development of innovative drugs, today announced positive results for its biomarker‑guided Phase 2b clinical trial (ENLIGHTEN) designed to assess the efficacy and safety of DB104 (liafensine) in patients with treatment-resistant depression (TRD).
  • More than 23 million people in the U.S. alone suffer from major depressive disorder (MDD).
  • TRD remains a highly unmet medical need indication as there are few approved pharmacological agents for TRD and overall, outcomes remain poor.
  • Using its unique big data based Denovo Genomic Marker (DGM™) biomarker platform, Denovo discovered a novel genetic biomarker, termed DGM4™, which was hypothesized to predict liafensine’s efficacy in TRD patients.

Cathy Nguyen Named Provider of the Month at Relief Mental Health in Chicago

Retrieved on: 
Tuesday, April 2, 2024

Relief Mental Health , a leading outpatient provider of transcranial magnetic stimulation (TMS), psychedelic therapy, psychiatric medication management, and talk therapy, is thrilled to announce Psychiatric Nurse Practitioner Cathy Nguyen, MSN APRN PMHNP-BC as its esteemed Provider of the Month.

Key Points: 
  • Relief Mental Health , a leading outpatient provider of transcranial magnetic stimulation (TMS), psychedelic therapy, psychiatric medication management, and talk therapy, is thrilled to announce Psychiatric Nurse Practitioner Cathy Nguyen, MSN APRN PMHNP-BC as its esteemed Provider of the Month.
  • Nguyen has exhibited exceptional dedication and expertise in providing innovative mental health care to the community at Relief’s West Loop clinic in Chicago.
  • Susan Mueller, CEO of Relief Mental Health, expressed her admiration for Nguyen’s commitment to the organization’s core values.
  • To make an appointment with Nguyen or for more information about the innovative services offered at Relief Mental Health, call 855.205.4764, email [email protected] or visit reliefmh.com .

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

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).

Toyota Maintains Leadership in Automotive Innovation, Top Spot Among Automakers in Annual U.S. Patent Ranking

Retrieved on: 
Tuesday, March 12, 2024

The ISO D seat assembly absorbs vehicle inputs vertically and laterally, reducing the overall load and impacts onto the vehicle occupant.

Key Points: 
  • The ISO D seat assembly absorbs vehicle inputs vertically and laterally, reducing the overall load and impacts onto the vehicle occupant.
  • ), thereby enhancing convenience and system integration as well as reducing space needs, cost, and weight of the vehicle.
  • Globally, Toyota spends approximately $1 million per hour on R&D, to ensure that Toyota rapidly and continuously develops cutting-edge, high-quality, and appealing vehicles and technologies.
  • This commitment ensures that Toyota not only delivers on the needs of customers but also anticipates its role in future societal progress.

Neuronetics Announces 5-Year Exclusive Partnership with Transformations Care Network

Retrieved on: 
Thursday, March 7, 2024

MALVERN, Pa., March 07, 2024 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced an expanded commercial partnership with Transformations Care Network ("TCN"), one of the nation's largest mental health care providers.

Key Points: 
  • MALVERN, Pa., March 07, 2024 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from neurohealth disorders, announced an expanded commercial partnership with Transformations Care Network ("TCN"), one of the nation's largest mental health care providers.
  • Under the new agreement, Neuronetics will be the exclusive supplier of new transcranial magnetic stimulation (TMS) equipment to TCN, increasing its NeuroStar TMS footprint and availability to patients.
  • "Transformations Care Network's alliance with NeuroStar is more than a milestone; it is a tangible manifestation of our vision to integrate the most advanced treatments in our suite of services," said Brian Wheelan, Chief Executive Officer at Transformations Care Network.
  • To learn more about Transformations Care Network, visit www.transformationsnetwork.com .

atai Life Sciences Announces First Participant Dosed in Phase 1b Trial of VLS-01

Retrieved on: 
Monday, March 4, 2024

The Phase 1b study is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT.

Key Points: 
  • The Phase 1b study is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT.
  • Top-line results for the Phase 1b study are expected in the second half of this year.
  • “I am delighted with the swift progress our team has made to commence dosing in the Phase 1b trial,” said atai Co-founder and Chief Executive Officer, Florian Brand.
  • The optimized formulation currently being tested is designed to improve PK and the patient experience ahead of moving into an anticipated Phase 2 trial with VLS-01 in TRD.

GH Research Reports Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Thursday, February 29, 2024

DUBLIN, Ireland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the year ended December 31, 2023, and provided updates on its business.

Key Points: 
  • DUBLIN, Ireland, Feb. 29, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today reported financial results for the year ended December 31, 2023, and provided updates on its business.
  • As announced in November 2023, both trials were recruiting slower than anticipated, in part due to the closure, for business reasons, of one of the two sites activated in each trial.
  • Subsequently, we have implemented measures to strengthen recruitment of both trials, including the addition of further clinical trial sites.
  • For the trial in patients with PPD (GH001-PPD-203), we now expect completion and availability of top-line data in the third quarter of 2024.