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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.

Axsome Therapeutics Initiates PARADIGM Phase 3 Trial of Solriamfetol for the Treatment of Major Depressive Disorder

Retrieved on:

Tuesday, March 19, 2024

Depression, MDD, Central nervous system, Patient, CNS, DSM-IV codes, Therapy, Safety, MADRS, Pharmaceutical industry

NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).

Key Points:

NEW YORK, March 19, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced the first patient has been dosed in the PARADIGM Phase 3 trial of solriamfetol, an investigational treatment for major depressive disorder (MDD).
PARADIGM (Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of MDD in adults.
Approximately 300 patients will be randomized in a 1:1 ratio to receive solriamfetol (300 mg) or placebo for 6 weeks.
The primary endpoint will be change in the Montgomery Åsberg Depression Rating Scale (MADRS).

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms

Retrieved on:

Monday, April 1, 2024

Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.

Key Points:

Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.
“While traditional approaches are often effective, many are left with only a partial response to treatment.
“The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder.
Rejoyn does not monitor the patient’s symptoms or clinical status and cannot send or receive alerts or warnings to the prescriber.

Supernus Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on:

Tuesday, February 27, 2024

ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Key Points:

Fourth quarter 2023 net sales of Qelbree® increased 97% to $46.4 million compared to fourth quarter 2022; Full year 2023 net sales of Qelbree increased 129% to $140.2 million compared to full year 2022.
Fourth quarter 2023 net sales of GOCOVRI® increased 10% to $32.0 million compared to fourth quarter 2022; Full year 2023 net sales of GOCOVRI increased 15% to $119.6 million compared to full year 2022.
Full year 2023 operating loss (GAAP) was $(5.3) million; Full year 2023 operating earnings (non-GAAP)(2), were $125.1 million.
ROCKVILLE, Md., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced financial results for the fourth quarter and full year of 2023 and associated Company developments.

Cybin Reports Third Quarter Financial Results and Recent Business Highlights

Retrieved on:

Wednesday, February 14, 2024

Announced positive Phase 2 topline efficacy and safety data for CYB003, the Company’s proprietary deuterated psilocybin analog, in MDD. The study achieved its primary efficacy endpoint with an impressive mean 14-point difference in Montgomery-Asberg Depression Rating Scale (“MADRS”) score reduction from baseline between CYB003 (12mg) vs. placebo (p=0.0005)1 at three weeks. At six weeks, incremental MADRS score reductions were seen with 79% of patients in remission from depression after just two 12mg doses of CYB003 -- an improvement that is far superior when compared against approved antidepressants and recently reported data with other psychedelics. Based on these encouraging results, and coupled with the fact that CYB003 is being developed as an adjunctive treatment that does not require candidates to discontinue the use of existing antidepressants, the Company intends to commence an international, multisite Phase 3 trial to further evaluate the safety and efficacy of CYB003 capsules in a larger MDD patient population2.

Key Points:

Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic treatment options, today reported unaudited financial results for its third quarter ended December 31, 2023, and recent business highlights.
Recent Business and Pipeline Highlights:
Announced positive Phase 2 topline efficacy and safety data for CYB003, the Company’s proprietary deuterated psilocybin analog, in MDD.
Combined Phase 1 results from DMT program support progression to a Phase 2a study in GAD in the first quarter of 20242.
Cash-based operating expenses totaled C$17.1 million for the quarter ended December 31, 2023, compared to C$11.1 million, in the prior year quarter.

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on:

Wednesday, January 24, 2024

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points:

Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

How Psychedelic-Based Therapeutics Are Advancing in Treating Generalized Anxiety Disorder (GAD) Condition

Retrieved on:

Wednesday, January 24, 2024

PALM BEACH, Fla., Jan. 24, 2024 /PRNewswire/ -- The coming years could see a massive shift in the U.S. government's approach to regulating hallucinogenic drugs. Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD). GAD is a prevalent mental health condition characterized by excessive and persistent worry, often extending beyond specific triggers. Individuals with GAD experience heightened levels of anxiety, anticipating future events and exhibiting physical symptoms such as muscle tension and restlessness. The disorder significantly impairs daily functioning and quality of life. A report from Delveinsight said that the total market size of the Generalized Anxiety Disorder (GAD) treatment market is anticipated to experience growth during the forecast period (2032) due to the emergence of new and effective treatments, especially numerous trials developing new and innovative next-generation psychedelic treatment options. The report added: "The diagnosis of Generalized Anxiety Disorder (GAD) involves a comprehensive assessment of an individual's mental health, considering the presence of excessive and uncontrollable worry across various aspects of life for a minimum of six months. Clinicians utilize standardized psychiatric interviews and validated screening tools to evaluate the severity of anxiety symptoms, along with a thorough exploration of associated physical and psychological manifestations. Differential diagnosis is crucial to rule out other psychiatric conditions, medical disorders, or substance-related issues that may mimic GAD symptoms. The diagnostic process also entails considering the impact of anxiety on daily functioning and its persistence in the absence of identifiable stressors. A multidimensional approach aids in ensuring an accurate diagnosis and facilitates the development of an effective treatment plan tailored to the individual's needs." Active Companies active today in markets include: Cybin Inc. (NYSE: CYBN) (NEO: CYBN), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED), Seelos Therapeutics, Inc. (NASDAQ: SEEL), atai Life Sciences (NASDAQ: ATAI).

Key Points:

Several biopharma companies are developing psychedelics-based treatments for various mental health conditions like Generalized Anxiety Disorder (GAD).
It continued: "DelveInsight's analyst projects that among the total diagnosed prevalent cases of Generalized Anxiety Disorder (GAD) in 7MM approximately 53% of cases were from the US.
The Generalized Anxiety Disorder (GAD) market is projected to witness consistent growth throughout the forecast period (2023–2032).
The market size of Generalized Anxiety Disorder (GAD) in the 7MM is expected to increase, driven by better diagnosis and the launch of emerging therapies."

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Retrieved on:

Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Key Points:

Human medicines European public assessment report (EPAR): Spravato, esketamine, Date of authorisation: 18/12/2019, Revision: 9, Status: Authorised

Sunstone Therapies Announces Publication of Positive Phase 2 Study Results in Cancer

Retrieved on:

Monday, December 18, 2023

Psilocybin, Clinical trial, Depression, MADRS, Safety, Patient, JAMA Oncology, DSM-IV codes, Pharmaceutical industry

Thirty participants completed the study, with results indicating that psilocybin-assisted therapy in group cohort administration was safe, feasible, and effective.

Key Points:

Thirty participants completed the study, with results indicating that psilocybin-assisted therapy in group cohort administration was safe, feasible, and effective.
These results showed that the group approach is feasible and many patients believed it to be of additional benefit.
A second study published in Cancer led by Yvan Beaussant, MD, MSc, of Dana-Farber Cancer Institute, gathered information from patients in the trial using exit interviews.
Efficient, scalable delivery while maintaining safety is a key issue for psilocybin-assisted therapy and the results of this study suggest a pathway towards wider and faster adoption in the future.”

Study results of psilocybin treatment in bipolar II depression published in JAMA Psychiatry

Retrieved on:

Wednesday, December 6, 2023

Psychiatry, JAMA Psychiatry, Headache, MD, Therapy, MADRS, Mental health, Annual general meeting, Bipolar II disorder, American College, Safety, Patient, CMPS

Results from the investigator-initiated open-label study were first presented at the Annual Meeting of the American College of Neuropsychopharmacology in 2022.

Key Points:

Results from the investigator-initiated open-label study were first presented at the Annual Meeting of the American College of Neuropsychopharmacology in 2022.
The study, which was conducted by Dr Scott Aaronson at Sheppard Pratt, Baltimore, and funded by Compass, investigated the safety and efficacy of a single 25mg dose of COMP360 psilocybin treatment in participants with treatment-resistant bipolar II.
The primary endpoint was change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 3.
“In what we believe to be the first study of its kind, we saw a significant number of patients experience relief from their bipolar II depression symptoms after a single 25mg dose of COMP360 psilocybin treatment.