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Cannabidiol - kali-extracts

Drug Profile

Cannabidiol - kali-extracts

Alternative Names: NCMB-1; RespRx

Latest Information Update: 11 Feb 2020

At a glance

  • Originator Kali-Extracts
  • Class Analgesics; Anti-inflammatories; Anti-ischaemics; Antiacnes; Antibacterials; Antiepileptic drugs; Antihyperglycaemics; Antihyperlipidaemics; Antineoplastics; Antipsoriatics; Antipsychotics; Antirheumatics; Antivirals; Anxiolytics; Cannabinoids; Cyclohexenes; Drug withdrawal therapies; Heart failure therapies; Hepatoprotectants; Muscle relaxants; Neuroprotectants; Obesity therapies; Skin disorder therapies; Small molecules
  • Mechanism of Action Cannabinoid receptor CB1 inverse agonists; Cannabinoid receptor CB2 inverse agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase I Chronic obstructive pulmonary disease
  • Research COVID 2019 infections; Respiratory tract disorders

Most Recent Events

  • 28 Jan 2020 Kali-Extracts files for patent protection for cannabidiol formulation for treatment of chronic obstructive pulmonary disease and other respiratory conditions
  • 28 Jan 2020 Early research in COVID-2019-infections in USA (PO)
  • 28 Jan 2020 Early research in Respiratory tract disorders in USA (PO)

Development Overview

Introduction

A liquid formulation of cannabidiol enriched extract (also known as NCMB1) has been developed by kali-extracts, for the treatment of symptoms associated with chronic obstructive pulmonary disease (COPD), coronavirus infection and other respiratory conditions. The company is employing a patented cannabis extraction process of NCM Biotech for extraction of cannabinoid extract. The formulation is in clinical development for the treatment of chronic obstructive pulmonary disease and in early research for the treatment of symptoms associated with COVID-2019 infections and other respiratory conditions in the US.

In 2018, kali-extracts acquired NCM Biotech [1] .

Key Development Milestones

As at July 2019, liquid formulation of cannabidiol was in a phase I development for the treatment of chronic obstructive pulmonary disease [1] .

In in vitro studies, liquid formulation of cannabidiol down-regulated genes responsible for inflammation and demonstrated improvement in airway function in non-human primates model of with chronic pulmonary fibrosis [2] [3] [4] .

Patent Information

In January 2020, Kali-Extracts reported filling of a patent application for cannabidiol formulation for the treatment of symptoms associated with chronic obstructive pulmonary disease (COPD) and other respiratory conditions [5] .

In December 2015, the US PTO issued a patent (No. 9 199 960 B2) entitled "Method and apparatus for processing herbaceous plant materials including the cannabis plant". The US patent provides protection to method to increase the yield of cannabinoids; particularly cannabidiol from Cannabis plant material [6] .

Drug Properties & Chemical Synopsis

  • Route of administration PO
  • Formulation Liquid
  • Class Analgesics, Anti-inflammatories, Anti-ischaemics, Antiacnes, Antibacterials, Antiepileptic drugs, Antihyperglycaemics, Antihyperlipidaemics, Antineoplastics, Antipsoriatics, Antipsychotics, Antirheumatics, Antivirals, Anxiolytics, Cannabinoids, Cyclohexenes, Drug withdrawal therapies, Heart failure therapies, Hepatoprotectants, Muscle relaxants, Neuroprotectants, Obesity therapies, Skin disorder therapies, Small molecules
  • Target Cannabinoid receptor CB1; Cannabinoid receptor CB1 inverse; Cannabinoid receptor CB2; Cannabinoid receptor CB2 inverse
  • Mechanism of Action Cannabinoid receptor CB1 inverse agonists; Cannabinoid receptor CB2 inverse agonists
  • WHO ATC code

    N03A-X24 (Cannabidiol)

    R (Respiratory System)

    R03 (Drugs for Obstructive Airway Diseases)

  • EPhMRA code

    R (Respiratory System)

    R3 (Anti-Asthma and COPD Products)

    V (Various)

  • Chemical name 2-[(1R,6R)-3-methyl-6-prop-1-en-2-ylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol
  • Molecular formula C21 H30 O2
  • CAS Registry Number 3556-78-3

Development Status

Summary Table

Indication Qualifier Patient Segment Phase Countries Route / Formulation Developers Event Date
COVID 2019 infections For symptoms associated with COVID-2019-infections - Research USA PO / Liquid Kali-Extracts 28 Jan 2020
Chronic obstructive pulmonary disease Foe symptoms associated with COPD - Phase I USA PO / Liquid Kali-Extracts 09 Jul 2019
Respiratory tract disorders - - Research USA PO / Liquid Kali-Extracts 28 Jan 2020

Commercial Information

Involved Organisations

Organisation Involvement Countries
Kali-Extracts Originator USA
Kali-Extracts Owner USA
University of Kentucky Collaborator USA

Scientific Summary

Pharmacodynamics

Summary

In nonhuman primates with chronic pulmonary fibrosis, 5-fold dilution of liquid cannabidiol formulation increased airway flow rate by 82%, respiration rate by 55%, airway flow rate by 82%, inspiratory airway flow velocity by 149%, and tidal volume by 38% compared with own control values after two weeks treatment. Improvement in pulmonary function in these primates also accompanied with increases in resting minute ventilation. Undiluted of liquid cannabidiol formulation also increased inspiratory flow rate by 49% and tidal volume by 24% after 2 weeks of treatment. Respiration rate was unchanged from pretreatment values. 25-fold dilution of liquid cannabidiol formulation did not showed any marked improvement on airway or lung functions. The data suggest potential of cannabidiol formulation for the treatment of chronic obstructive airway diseases that restrict inspiratory air flow [3] [4] .

In in vitro studies, cannabinoids extract alone demonstrated up- or down-regulating genes responsible for inflammation and healing by as much as 200-fold in human small airway epithelial cells (HSAEpC) [2] .

Development History

Event Date Update Type Comment
28 Jan 2020 Patent Information Kali-Extracts files for patent protection for cannabidiol formulation for treatment of chronic obstructive pulmonary disease and other respiratory conditions [5] Updated 11 Feb 2020
28 Jan 2020 Phase Change Early research in COVID-2019-infections in USA (PO) [5] Updated 03 Feb 2020
28 Jan 2020 Phase Change Early research in Respiratory tract disorders in USA (PO) [5] Updated 03 Feb 2020
09 Jul 2019 Phase Change - I Phase-I clinical trials in Chronic obstructive pulmonary disease in USA before July 2019 (PO) [1] Updated 03 Feb 2020
01 Feb 2019 Phase Change - Preclinical Preclinical trials in Chronic obstructive pulmonary disease in USA (PO) before February 2019 [3] Updated 03 Feb 2020
01 Feb 2019 Scientific Update Pharmacodynamics data from preclinical studies in Chronic obstructive pulmonary disease released by Kali-Extracts [3] [4] Updated 03 Feb 2020
19 Dec 2018 Scientific Update Pharmacodynamics data from in vitro studies in Chronic obstructive pulmonary disease released by Kali-Extracts [2] Updated 03 Feb 2020
01 Dec 2015 Patent Information kali-extracts has patent protection for extraction method of cannabinoids in USA [6] Updated 03 Feb 2020

References

  1. KALY Adds New CBD Extraction Contract Worth $10 Million in Annual Revenue.

    Media Release
  2. Kali-Extracts, Inc. Releases Preclinical Research Study Results on Therapy for Respiratory Disease Driving $11 Billion Treatment Market.

    Media Release
  3. KALY - Kali-Extracts, Inc. Announces Cannabis Extract COPD Primate Treatment Study Research Report Preview.

    Media Release
  4. KALY - Kali-Extracts, Inc. Previews Pending Report On Cannabis Treatment For Lung Disease Study.

    Media Release
  5. KALY-Kali-Extracts RespRx Could Offer Treatment for Coronavirus Symptoms.

    Media Release
  6. Method and apparatus for processing herbaceous plant materials including the cannabis plant - Patent. Internet-Doc 2020;.

    Available from: URL: https://patents.google.com/patent/US9199960B2/en?oq=9%2c199%2c960
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