Acetazolamide

Glycomine Announces Encouraging Efficacy Data from Ongoing Phase 2 Clinical Study in PMM2-CDG

Retrieved on: 
Monday, March 4, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Rare disease, International, Caregiver, Adolescence, CMO, Acetazolamide, Quality of life, Conference, Ataxia, Patient, PMM2-CDG, Trial of the century

This compares favorably to prior results reported with acetazolamide which demonstrated an average improvement of 6 points after 25 weeks in adult and pediatric patients (n=25).

Key Points: 
  • This compares favorably to prior results reported with acetazolamide which demonstrated an average improvement of 6 points after 25 weeks in adult and pediatric patients (n=25).
  • “We are very encouraged by the initial results we have seen and delighted to be part of this important study.”
    The GLM101-002 Phase 2 clinical study has enrolled 10 adult patients in the U.S. and Spain (ClinicalTrials.gov Identifier: NCT05549219).
  • Study participants have received GLM101 at either 10 mg/kg (n=3), 20 mg/kg (n=3), or 30 mg/kg (n=4) for up to 24 weeks.
  • Four adolescent patients have initiated treatment, and the study is planned to be extended into younger PMM2-CDG patients in the coming months.

Incannex Receives IRB Approval for the RePOSA Phase 2/3 Clinical Trial Protocol to Assess IHL-42X Drug in Patients with Obstructive Sleep Apnea

Retrieved on: 
Wednesday, January 17, 2024
Ageing, Patient, Research, Dronabinol, PAP, Obstructive sleep apnea, Continuous positive airway pressure, AHI, API, Risk, Positive airway pressure, IRB, Acetazolamide, CPAP, Food, OSA, Safety, Institutional review board, Pharmaceutical industry

IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study.

Key Points: 
  • IRB approval of the protocol is a key step in activation of clinical trial sites for the RePOSA study.
  • The approval process involves review of the research protocol, informed consent procedures, recruitment materials, and participant risk versus benefit analysis.
  • The study is designed to facilitate a seamless transition between Phase 2 and Phase 3, reducing downtime and accelerating development timelines.
  • IRB approval of the protocol allows the U.S.-based sites to proceed with site-specific approval, which is a critical step in site activation.

Incannex Update on IHL-42X Drug Candidate in Phase 2/3 Clinical Trial in Obstructive Sleep Apnea

Retrieved on: 
Wednesday, December 6, 2023
Obstructive sleep apnea, Deficit spending, Depression, Disease, Ageing, Blood, Claustrophobia, Accident, Dronabinol, Death, Workplace, Metabolic acidosis, Noise, Conditional sentence, Sleep, Amnesia, Patient, Diagnosis, Cardiovascular disease, PAP, Safety, CO2, AHI, PSG, Somnolence, Acetazolamide, Polysomnography, Judgement, Pharmaceutical industry

Obstructive sleep apnea (OSA) is characterised by a narrowing or obstruction of the upper airway during sleep, which interrupts breathing resulting in decreased oxygen uptake and poor sleep quality.

Key Points: 
  • Obstructive sleep apnea (OSA) is characterised by a narrowing or obstruction of the upper airway during sleep, which interrupts breathing resulting in decreased oxygen uptake and poor sleep quality.
  • Incannex has designed IHL-42X, a combination of dronabinol (synthetic THC) and acetazolamide, for treatment of OSA.
  • A video presentation of IHL-42X for the treatment of OSA has been uploaded to the Incannex website, link here: https://www.incannex.com/clinical-trail/ihl-42x-osa/ .
  • This gave Incannex the confidence to proceed with a multisite Phase 2/3 clinical trial further investigating safety and efficacy of IHL-42X in patients with OSA.

Review of IND Application for IHL-42X by US FDA has been completed; Clinical Trial for Patients with Obstructive Sleep Apnoea May Proceed

Retrieved on: 
Tuesday, August 22, 2023
Communication, US Foods, CPAP, Acetazolamide, Sleep, Clinical trial, ASX, Dronabinol, Patient, IRB, AHI, FDA, IND, Food, Safety, Pharmaceutical industry

Incannex submitted the IND application on 20 July 2023 and the FDA completed their review of the substantial application package during the allocated 30-day period.

Key Points: 
  • Incannex submitted the IND application on 20 July 2023 and the FDA completed their review of the substantial application package during the allocated 30-day period.
  • Incannex received communication that the FDA review was completed, and the IND-opening clinical trial is deemed safe to proceed following assessment of the trial protocol, lead trial investigators, and a risk benefit analysis of the trial and prospective product.
  • The IND opening trial will assess the effect of IHL-42X in obstructive sleep apnoea patients who are non-compliant, intolerant, or naïve to positive airway pressure treatment, such as that administered by CPAP devices.
  • In the IND opening Phase 2/3 clinical trial, participants will receive one dose of IHL-42X, dronabinol, acetazolamide or placebo for the entirety of the trial.

Incannex Submits IND Application to the US FDA for IHL-42X for Obstructive Sleep Apnoea

Retrieved on: 
Friday, July 21, 2023
Psychology, Ohio State University, Sleep apnea, US Foods, University, Obstructive sleep apnea, Acetazolamide, Sleep, Clinical trial, Trial of the century, ASX, Research, Dronabinol, Investigational New Drug, MD, Patient, Medical Center, Principal, FDA, IND, Food, Safety, Pharmaceutical industry, Neurology

The IND dossier compiled by the Incannex team includes comprehensive modules on the safety and efficacy of IHL-42X and its component active pharmaceutical ingredients.

Key Points: 
  • The IND dossier compiled by the Incannex team includes comprehensive modules on the safety and efficacy of IHL-42X and its component active pharmaceutical ingredients.
  • The FDA review process for an IND application involves evaluation of the scientific, clinical, and safety aspects to ensure that the proposed clinical trial meets regulatory requirements.
  • The IND application details the clinical trial protocol for the IND opening clinical trial, which is a multi-site phase 2/3 clinical trial investigating IHL-42X for the treatment of Obstructive Sleep Apnoea (‘OSA’).
  • This announcement has been approved for release to ASX by the Incannex Board of Directors.

Incannex engages Fortrea to Manage its FDA IND Opening Phase 2/3 Clinical Trial Investigating IHL-42X for Treatment of Obstructive Sleep Apnoea

Retrieved on: 
Tuesday, July 18, 2023
Drug development, Acetazolamide, Sleep, Clinical trial, ASX, OSA, Dronabinol, Patient, United States Commercial Service, AHI, IND, Safety, Pharmaceutical industry, Medical imaging

MELBOURNE, Australia, July 18, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it has engaged Fortrea (Nasdaq: FTRE) as the contract research organisation (‘CRO’) for management of the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA.

Key Points: 
  • Incannex has engaged Fortrea as the contract research organisation (‘CRO’) to manage the IND opening Phase 2/3 clinical trial investigating IHL-42X for treatment of OSA.
  • Fortrea will implement its technology enabled clinical trial solutions designed to increase drug development efficiency, reduce timelines, and improve compliance.
  • Incannex is targeting 45 clinical trial sites to be included in the study and recently appointed two highly experienced lead principal investigators to the study.
  • These results were truly remarkable and now allows for this Phase 2/3 trial to be a genuine long-term safety and efficacy trial.

Incannex Receives Ethics Approval for Bioequivalence/Bioavailability Clinical Trial for IHL-42X, the Company’s Proprietary Drug for Treatment of Obstructive Sleep Apnoea (‘OSA’)

Retrieved on: 
Thursday, July 6, 2023
Sleep apnea, US Foods, Food, Acetazolamide, Clinical trial, Food and Drug Administration, Pharmacokinetics, Data collection, ASX, CMAX, Research, OSA, Dronabinol, API, FDA, IND, Safety, Pharmaceutical industry, Generic drug

MELBOURNE, Australia, July 06, 2023 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that Incannex has received approval from Bellberry Human Research Ethics Committee to commence a bioavailability/bioequivalence (‘BA/BE’) clinical trial on IHL-42X, the Company’s proprietary drug product for treatment of obstructive sleep apnoea.

Key Points: 
  • The design of the BA/BE trial is consistent with FDA recommendations as part of the required research required to undertake a new drug application.
  • The clinical trial will be conducted at CMAX Clinical Research in Adelaide, South Australia and managed by Novotech.
  • Importantly, the BA/BE study will run in parallel to the pivotal Phase 2/3 trial that will commence after the Company opens an IND with the FDA.
  • Incannex Chief Scientific Officer Dr Mark Bleackley said: “The BA/BE trial is a very important component of the IHL-42X pipeline.

Incannex Expands Intellectual Property Position over IHL-42X

Retrieved on: 
Tuesday, December 6, 2022
Government budget balance, Accident, Associate, Depression, Sleep, Muscle, Clinical trial, Patent Cooperation Treaty, Incidence, Irritability, ASX, Cardiovascular disease, Obstructive sleep apnea, Hypertension, Continuous positive airway pressure, Fatigue, Sleep-related breathing disorder, THC, US, Dronabinol, Physiology, University, Polysomnography, AHI, Acetazolamide, Loop gain, Metabolic acidosis, CPAP, Research, Apnea–hypopnea index, Patent, Risk, Blood, Finswimming at the 2017 World Games – Men's 50 m apnoea, Patient, Monash University, Anxiety, Pharmaceutical industry, Medical device

Dronabinol is believed to activate muscles in the upper airway during sleep, thereby reducing incidence of airway collapse.

Key Points: 
  • Dronabinol is believed to activate muscles in the upper airway during sleep, thereby reducing incidence of airway collapse.
  • Incannex previously discovered that the two drugs act synergistically to reduce the Apnea Hypopnea Index (AHI) in patients with OSA.
  • CEO and Managing Director of Incannex Healthcare, Mr Joel Latham said; “Incannex works closely with its patent attorneys to build upon its competitive position through the ongoing development of intellectual property assets.
  • Results from a Phase 2 proof of concept clinical trial undertaken by Incannex were published in 2022.

Incannex Development Update for IHL-42X for Obstructive Sleep Apnoea (‘OSA’)

Retrieved on: 
Thursday, November 17, 2022
Hypertension, THC, Dronabinol, Pharmacokinetics, Food, Blood, IND, Risk, Safety, ASX, API, Patient, Cardiovascular disease, Sleep, Fatigue, AHI, OSA, Anxiety, Accident, US, Patent, Depression, Continuous positive airway pressure, Research, Sleep-related breathing disorder, Clinical trial, Irritability, Government budget balance, Acetazolamide, FDA, BA, CPAP, Pharmaceutical industry, Medical device

MELBOURNE, Australia, Nov. 17, 2022 (GLOBE NEWSWIRE) -- Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that Incannex has initiated a BA/BE study and is targeting submission of an IND application with the FDA in Q1 2023.

Key Points: 
  • The design of the BA/BE study is consistent with FDA recommendations for BA/BE and specific advice received by Incannex in the pre-IND meeting.
  • In parallel with the BA/BE study, Incannex is preparing an IND application for submission to the FDA.
  • Once the IND is opened, it is continuously updated with research and development results for the purpose of ongoing assessment by the FDA.
  • It is estimated that the annual economic burden of undiagnosed sleep apnoea among U.S. adults is approximately US$149.6 billion per annum.

AI Startup AESOP Raises $3M to Tackle Medical and Billing Errors

Retrieved on: 
Wednesday, August 31, 2022
Mayo Clinic, Information system, TMU, Technology, Digital, SAN, Insurance, International Medical Informatics Association, Solution, Decision-making, Glaucoma, Physician, Taipei Medical University, Diagnosis, CIO, Hospital, Medical school, Approximation error, Yu-Chuan Jack Li, Big data, Harvard University, Medicine, Capital University of Medical Sciences, AI, Altitude, Medical device, Acetazolamide, AESOP, Paracetamol

SAN FRANCISCO, Aug. 31, 2022 /PRNewswire/ -- Digital health startup AESOP Technology has raised a $2.95 million series pre-A round to address the growing medical and billing errors problem.

Key Points: 
  • SAN FRANCISCO, Aug. 31, 2022 /PRNewswire/ -- Digital health startup AESOP Technology has raised a $2.95 million series pre-A round to address the growing medical and billing errors problem.
  • Originally from Taiwan, AESOP started as a universityspin-off from Taipei Medical University (TMU).Professor Yu Chuan (Jack)Li, the founder and current president of the International Medical Informatics Association,spent tenyears before AESOP working on big data approaches to reduce medication errors.
  • He initially applied the model to launch a product, RxPrime (previously known asMedGuard), that identifies wrong-drug errors.
  • They worked together to broaden the types of errors the AI could identify and on products they could use to improve the US healthcare system.