Peripheral nervous system

EQS-News: Newron reports striking one-year interim efficacy results from its Phase II clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia

Retrieved on: 
Wednesday, February 22, 2023
XETRA, Manhattan Psychiatric Center, Psychiatry, PANSS, Positive, Safety, Patient, Nathan Kline Institute for Psychiatric Research, CNS, Peripheral nervous system, CET, Psychosis, Congress, TRS, Disease, Clozapine, Schizophrenia International Research Society, European, Headache, Clinical Global Impression, Pharmaceutical industry, Newron Cup, Research

Results from these same 100 patients at six weeks and six months in study 014/015 have been reported previously.

Key Points: 
  • Results from these same 100 patients at six weeks and six months in study 014/015 have been reported previously.
  • Further evidence of the progressive benefit over time was evident from the growing proportion of patients rated “very much improved” at one year.
  • These Phase II, open-label data of evenamide in patients with TRS, obtained with blinded raters, are very promising.
  • The company continues its dialogue with industry partners around potential future collaboration opportunities for the development of evenamide.

Newron Reports Striking One-Year Interim Efficacy Results From Its Phase II Clinical Trial Evaluating Evenamide as Add-On Therapy for Patients With Treatment-Resistant Schizophrenia

Retrieved on: 
Thursday, February 16, 2023
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, XETRA, Manhattan Psychiatric Center, Psychiatry, PANSS, Positive, Safety, Patient, Nathan Kline Institute for Psychiatric Research, CNS, Peripheral nervous system, CET, Congress, TRS, Disease, Clozapine, Schizophrenia International Research Society, European, Headache, Clinical Global Impression, Medication, Pharmaceutical industry, Newron Cup

Results from these same 100 patients at six weeks and six months in study 014/015 have been reported previously.

Key Points: 
  • Results from these same 100 patients at six weeks and six months in study 014/015 have been reported previously.
  • These Phase II, open-label data of evenamide in patients with TRS, obtained with blinded raters, are very promising.
  • Newron expects to initiate a potentially pivotal, multinational, randomized, placebo-controlled trial in patients with TRS (study 003) in 2023, as part of its ongoing Phase II/III development plan for evenamide.
  • The company continues its dialogue with industry partners around potential future collaboration opportunities for the development of evenamide.

Amber Therapeutics announces successful first-in-human implants of Amber-UI: an intelligent, closed-loop bioelectrical therapy for urge and mixed urinary incontinence

Retrieved on: 
Tuesday, January 24, 2023
Safety, Therapy, Pudendal nerve, University, Incontinence, Overactive bladder, Amber, Human, Genta (company), Partnership, UKRI, University of Oxford, Trial of the century, Queen Mary University of London, Raeng Ngao, DBS, Oxford Sciences Enterprises, Stress incontinence, Lifting, Urinary incontinence, Patient, Woman, DSM-IV codes, Peripheral nervous system, University of Antwerp, Cough, UI, Medical imaging, Pharmaceutical industry, Medical device, Urology

To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).

Key Points: 
  • To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).
  • AURA-2 is designed to evaluate the safety and pilot efficacy of Amber-UI in 15 women.
  • Aidan Crawley, CEO of Amber commented: "Reaching this first-in-human milestone in under two years demonstrates our ability to rapidly prototype new bioelectrical therapy concepts.
  • With our Amber-UI adaptive therapy, we finally have the potential to control both forms of incontinence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence."

Amber Therapeutics announces successful first-in-human implants of Amber-UI: an intelligent, closed-loop bioelectrical therapy for urge and mixed urinary incontinence

Retrieved on: 
Tuesday, January 24, 2023
Safety, Therapy, Pudendal nerve, University, Incontinence, Overactive bladder, Amber, Human, Genta (company), Partnership, UKRI, University of Oxford, Trial of the century, Queen Mary University of London, Raeng Ngao, DBS, Oxford Sciences Enterprises, Stress incontinence, Lifting, Urinary incontinence, Patient, Woman, DSM-IV codes, Peripheral nervous system, University of Antwerp, Cough, UI, Medical imaging, Pharmaceutical industry, Medical device, Urology

To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).

Key Points: 
  • To explore the clinical potential of Amber-UI, the Company initiated its ground-breaking AURA-2 (Augmenting Urinary Reflex Activity) first-in-human study in late 2022 (clinicaltrials.gov identifier: NCT05241379).
  • AURA-2 is designed to evaluate the safety and pilot efficacy of Amber-UI in 15 women.
  • Aidan Crawley, CEO of Amber commented: "Reaching this first-in-human milestone in under two years demonstrates our ability to rapidly prototype new bioelectrical therapy concepts.
  • With our Amber-UI adaptive therapy, we finally have the potential to control both forms of incontinence: relaxing the bladder to treat urge and closing the sphincter to treat stress incontinence."

Psycheceutical Announces Completion of Pre-IND Meeting with FDA for Topical Ketamine Drug to Treat PTSD

Retrieved on: 
Thursday, February 2, 2023
Ketamine, Mental health, Peripheral nervous system, Vomiting, Food, PTSD, II, IND, Post-traumatic stress disorder, Tissue (biology), Nausea, Therapy, Drug discovery, Hallucination, Neck, Patient, Breakthrough therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Neuro, Toxicity, Pharmaceutical industry

The FDA has given guidance to Psycheceutical regarding its development plans for preclinical studies required for an IND submission and the design of related Phase I and II clinical studies.

Key Points: 
  • The FDA has given guidance to Psycheceutical regarding its development plans for preclinical studies required for an IND submission and the design of related Phase I and II clinical studies.
  • In 2023, Psycheceutical remains focused on completing the remaining IND-enabling studies that will support the IND submission and transition into Phase I and Phase II clinical studies.
  • "We are undergoing a mental health epidemic, with millions suffering from conditions like PTSD with no current therapeutics on the market to help.
  • We believe that NeuroDirect™ ketamine has the potential to be a life-altering treatment option that will provide profound benefits and relief to patients suffering from PTSD,” said Chad Harman, CEO of Psycheceutical.

Avenue Therapeutics Announces Closing of $3.25 Million Registered Direct and Private Placement

Retrieved on: 
Tuesday, January 31, 2023
Peripheral nervous system, Telephone, Attention, Special-purpose acquisition company, Form S-3, Avenue, Sale, Form, Prospectus, Exercise, Therapy, Security (finance)

The Company issued 1,940,299 shares of common stock and pre-funded warrants to acquire common stock in a registered direct offering.

Key Points: 
  • The Company issued 1,940,299 shares of common stock and pre-funded warrants to acquire common stock in a registered direct offering.
  • The private placement warrants will be exercisable immediately subject to registration and will have a 3-year term from the initial exercise date.
  • Aggregate gross proceeds to the Company of both transactions were approximately $3.25 million.
  • The registered direct offering is being made pursuant to an effective shelf registration statement on Form S-3 (No.

Avenue Therapeutics Announces $3.25 Million Registered Direct and Private Placement Priced at the Market Under Nasdaq Rules

Retrieved on: 
Friday, January 27, 2023
Peripheral nervous system, Telephone, Attention, Special-purpose acquisition company, Form S-3, Avenue, Sale, Form, Prospectus, Exercise, Therapy, Security (finance)

The private placement warrants will be exercisable immediately subject to registration and will have a 3-year term from the initial exercise date.

Key Points: 
  • The private placement warrants will be exercisable immediately subject to registration and will have a 3-year term from the initial exercise date.
  • Aggregate gross proceeds to the Company of both transactions are expected to be approximately $3.25 million.
  • The transactions are expected to close on or about January 31, 2023, subject to the satisfaction of customary closing conditions.
  • The entire transaction has been priced at the market under Nasdaq rules.

Psycheceutical Bioscience Provisional Patent Application for Novel Ketamine Topical for the Treatment of PTSD

Retrieved on: 
Thursday, January 26, 2023
Mental health, Ketamine, Peripheral nervous system, Vomiting, Suicide, PTSD, Post-traumatic stress disorder, Nausea, Tissue (biology), Speech disorder, Risk, OTC, United States Patent and Trademark Office, Hallucination, Depression, Neck, Patient, Patent, Anxiety, Lethargy, Hope, Neuro, Toxicity, Pain, Pharmaceutical industry

MIAMI, Jan. 26, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc ("Psycheceutical" or the "Company") (OTC: BWVI), a bioscience company dedicated to developing cutting-edge treatments for mental health, has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for the first ketamine topical intended for treating post-traumatic stress disorder (PTSD).

Key Points: 
  • MIAMI, Jan. 26, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc ("Psycheceutical" or the "Company") (OTC: BWVI), a bioscience company dedicated to developing cutting-edge treatments for mental health, has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) for the first ketamine topical intended for treating post-traumatic stress disorder (PTSD).
  • The provisional patent application describes ketamine formulations for topical administration and related methods of treating PTSD, utilizing NeuroDirect™ non-systemic drug delivery technology.
  • These novel ketamine formulations, and methods of treatment, are being developed to reduce the side effects caused by prior formulations, such as hallucinations, nausea, lethargy, and toxicity, but more importantly to also reduce pain and symptoms of PTSD.
  • “PTSD can be a serious mental health disorder, with no known effective therapeutic solutions currently available.

NeuroMetrix® Announces Launch of DPNCheck® 2.0, its Fast, Accurate, Quantitative Screening Test for Peripheral Neuropathy

Retrieved on: 
Monday, January 23, 2023
Cloud, Pain, Medicare, EHR, Peripheral nervous system, Peripheral neuropathy, Risk, Conference, Patient, Falls, Temperature, Pharmaceutical industry

DPNCheck 2.0 provides rapid patient screening with quantitative measurement of peripheral nerve function.

Key Points: 
  • DPNCheck 2.0 provides rapid patient screening with quantitative measurement of peripheral nerve function.
  • It features an easy-to-use touchscreen, onboard step-by-step instructions, improved temperature compensation, real-time nerve response display and other enhancements.
  • Peripheral neuropathy, the systemic degeneration of peripheral nerves, is a common and debilitating condition that may affect up to 30% of the Medicare-aged population.
  • “We are excited to launch our newest version to even better address the needs of our clinical partners.

Trevena Enrolls First Subject in TRV045 Proof-of-Concept Trial Evaluating S1PR Mechanism of Action and Target Engagement

Retrieved on: 
Monday, January 9, 2023
IND, CNS, Trial of the century, PK, Trevena, Central nervous system, Patient, Peripheral nervous system, S1P, Central nervous system disease, Pain, Pharmaceutical industry

CHESTERBROOK, Pa., Jan. 09, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the enrollment of the first subject in a Phase 1 proof-of-concept study of TRV045, a novel sphingosine-1-phosphate receptor modulator selective for the S1P receptor subtype 1.

Key Points: 
  • The Phase 1 clinical study is a randomized, double-blind, placebo-controlled, four-way cross-over study designed to test the mechanism of action and measure evidence of target engagement for TRV045.
  • The study will use a validated set of analgesic tests to evaluate potential central and peripheral nervous system effects and to provide insight into the potential anti-inflammatory actions of TRV045.
  • The first subject in the trial was dosed in December 2022 and the study is expected to complete enrollment by mid-2023.
  • “We look forward to reporting topline data from this target engagement study, which will help inform our future development path for TRV045.”