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Revive Therapeutics Ltd (RVVTF) RSS Feed

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Revive Therapeutics updates on potential COVID-19 treatment

https://www.globenewswire.com/news-release/2020/04/08/2013654/0/en/Revive-Therapeutics-Engages-Novotech-as-Asia-Pacific-CRO-for-Bucillamine-in-the-Treatment-of-Infectious-Diseases.html



Revive Therapeutics Announces Filing of a Pre-CTA Meeting Request with Health Canada and Update on U.S. FDA IND Filing and Phase 3 Clinical Trial Design for Bucillamine in the Treatment of COVID-19
 

 

Scientific Rationale of Bucillamine

Preclinical and clinical studies have demonstrated that reactive oxygen species contribute to the destruction and programmed cell death of pulmonary epithelial cells.1 N-acetyl-cysteine (NAC) has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to restore antioxidant and to reduce the activity of cellular glutathione 2,3,4,5. Bucillamine (N-(mercapto-2-methylpropionyl)-l-cysteine) has a well-known safety profile and is prescribed in the treatment of rheumatoid arthritis in Japan and South Korea for over 30 years. Bucillamine, a cysteine derivative with two thiol groups, has been shown to be 16 times more potent as a thiol donor in vivo than NAC 6. The drug is non-toxic with high cellular permeability. The basis of the clinical study will analyze if Bucillamine has the potential, via restoration of glutathione activity and other anti-inflammatory activity, to lessen the negative consequences of SARS-CoV2 infection in the lungs.


PATENT PORTFOLIO Title USPTO No. Status Use of Bucillamine in the Treatment of Infectious Diseases, including COVID-19 62/991,996 Provisional patent filed Use of Bucillamine in the Treatment of Gout US9662305 Issued on May 30, 2017 Drug Delivery System US 8642088 US 9545423 US 10104888 Issued on February 4, 2014 Issued on January 17, 2017 Issued on October 23, 2018 Psilocybin effervescent and psilocybin tablet - Solid Oral Pharmaceutical Compositions 62/985,052 Provisional patent filed Psilocybin hard-shell capsules - Pharmaceutical Capsule Compositions 62/985,070 Provisional patent filed Psilocybin gum drops - Pharmaceutical Gumdrop Compositions 62/985,084 Provisional patent filed Psilocybin oral strips and transmucosal - Thin-Film Pharmaceutical Delivery System and Formulations 62/985,098 Provisional patent filed Psilocybin - Pharmaceutical Formulations and Methods for Sublingual and Buccal Administration 62/984,590 Provisional patent filed Methods for the Extraction and Crystallization of Psilocybin 62/985,360 Provisional patent filed Use of Cannabidiol in the Treatment of Autoimmune Hepatitis US 8242178 Issued on August 14, 2012

Focus on Infectious Diseases, including COVID-19, and Rare Disorders:

1. Bucillamine Infectious Diseases (COVID-19) Filing IND IND for Phase 3 Market size =TBD 
2. Psilocybin Undisclosed Pre-clinical Target FDA Orphan Status + $500M
3. Psilocybin Undisclosed Multiple Indications Pre-clinical Target FDA Orphan Status Market size =TBD
4. CBD Liver Diseases (Autoimmune Hepatitis) Filing IND Received FDA Orphan Status IND for Phase 2 Psilocybin Undisclosed Pre-clinical Target FDA Orphan Status + $500M Psilocybin Undisclosed Multiple Indications Pre-clinical Target FDA Orphan Status TBD                                                                                                                      BUC shown superior function in restoring glutathione and therefore greater potential to prevent acute lung injury during influenza infection
 BUC also shown to prevent oxidative and reperfusion injury in heart and liver tissues §
 BUC proven safety and MOA similar to NAC, but with much higher potency §


Pschedelic Opportunity 

§ Acquired Psilocin Pharma Corp. § Derrick Welch, Founder with 14 years of HC experience; 5 years in Cannabis § Worked with Xanthic Bio Pharma and Green Growth Brands
§ Developed water Soluble THC and CBD products (Beverages, effervescent tablets)
§ Novel Psilocybin formulations, extraction and purification methods
§ Suited for pharmaceutical development and recreational markets where legal
§ Patent pending Psilocybin formulations (natural synthetic derived)
§ Capsules, Sublingual Spray, Gel Cap, Effervescent Tablets, and Oral Strips
§ Targeting rare diseases, mental health and addiction


LIVER DISEASE OPPORTUNITY
§ Focus on Autoimmune Hepatitis (AIH) § AIH - rare disease (~ 76k patients in US) causing liver inflammation • Drawbacks of current therapies (steroids): Severe side effects in 13%, relapse after drug withdrawal in 50%-86%*
§ Obtained FDA orphan drug status for CBD in the treatment of AIH
§ Seeking to file FDA IND to conduct Phase 2 clinical study in patient affected by AIH § Big Pharma interest in liver diseases § Allergan acquisition of Tobira for $1.7 billion
§ Novartis license of Conatus drug for $650 million
§ Gilead acquisition of Nimbus for $1.2 billion


STRATEGIC PARTNERS:
A. Pharm Olam
B.Psilocin Corp (Aquired) 
C.Wisconsin University
D.South Carolina University 
E.WARF Wisconsin Alumni Research Foundation 
F.Sanyal Biotechnology 

Team:

Management § Michael Frank Chairman and CEO § Carmelo Marrelli Chief Financial Officer § Derrick Welsh Founder, Psilocin Pharma Corp. Clinical § Dr. Kelly McKee, Jr., MD, MPH Chief Scientific Officer, Consultant § Dr. David Boulware, MD, MPH, CTropMed, FIDSA Clinical and Scientific Advisor § Dr. Onesmo Mpanju, PhD FDA Regulatory Affairs, Consultant. Board of Directors § Michael Frank Chairman and CEO § William Jackson Director § Joshua Herman Director § Christian Scovenna Director § Andrew Lindzon Director.  Muthuri SG, Venkatesan S, Myles PR et al. Effectiveness of neuraminidase inhibitors in reducing mortality in patients admitted to hospital with influenza A H1N1pdm09 virus infection: a meta-analysis of individual participant data Lancet Respir Med. 2014 May;2(5):395-404. doi: 10.1016/S2213-2600(14)70041-4. 2. Duwe S. Influenza viruses – antiviral therapy and resistance. GMS Infect Dis. 2017; 5: Doc04. 3. Zhang RH, Li CH, Wang CL et al. N-acetyl-l-cystine (NAC) protects against H9N2 swine influenza virus-induced acute lung injury. Int Immunopharmacol. 2014 Sep;22(1):1-8. doi: 10.1016/j.intimp.2014.06.013. 4. Ungheri D, Pisani C, Sanson G et al. Protective effect of n-acetylcysteine in a model of influenza infection in mice. Int J Immunopathol Pharmacol. 2000 SepDec;13(3):123-128. 5. De Flora S, Grassi C, and Carati L. Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment. Eur Respir J 1997; 10: 1535–1541 DOI: 10.1183/09031936.97.10071535 6. Poole LB. The Basics of Thiols and Cysteines in Redox Biology and Chemistry. Free Radic Biol Med. 2015 Mar; 0: 148–157. doi: 10.1016/j.freeradbiomed.2014.11.013. 7. Mata M, Morcillo E, Gimeno C, Cortijo J. N-acetyl-L-cysteine (NAC) inhibit mucin synthesis and pro-inflammatory mediators in alveolar type II epithelial cells infected with influenza virus A and B and with respiratory syncytial virus (RSV). Biochem Pharmacol. 2011 Sep 1;82(5):548-55. doi: 10.1016/j.bcp.2011.05.014. 8. Horowitz LD. Bucillamine: a potent thiol 

https://www.globenewswire.com/news-release/2020/03/05/1996118/0/en/Revive-Announces-Closing-of-the-Acquisition-of-Psilocin-Pharma-Corp.html

Websitehttps://www.revivethera.com




 


Advancing Psilocybin Drug Development.

 

About Psilocin Pharma Corp.

 
Psilocin Pharma Corp. has developed production solutions for the active compound Psilocybin. Our process encompassed with our intellectual property cover methods of production of Psilocybin based formulations. Psilocin Pharma Corp’s range of products have been engineered to work synergistically with the body's own natural pathways of absorption while offering a contemporary approach to consumption. Psilocin Pharma also has strong relationships with specific lab partners in certain areas like Brazil, where these formulations are legally approved and plan to sell products in these jurisdictions.
 
 
 
 
 


Our Products

 

We have developed six unique formulations to date in the form of Capsules (PSY-0.1),  Sublingual Spray (PSY-0.2), Gel Cap (PSY-0.3), Effervesce Tablets (PSY-0.4/0.5), Breath Strip (PSY-0.6). The precisely dosed formulations work with both natural and synthetically derived Psilocybin which will be targeted for clinical research and subject to eventually FDA approval in the treatment of Depression, Anxiety, Bi-polar disorder, Bulimia & Anorexia Nervosa, etc.  Psilocin Pharma Corp’s range of products have been engineered to work synergistically with the body's own natural pathways of absorption while offering a contemporary approach to consumption. 
 

Market Opportunity (MEDICAL)

 

Mental Health (Depression, PTSD & Anxiety)
  • 450,000,000 people globally suffer from mental health illness
Eating Disorders (Anorexia, Bulimia & other classified EDs)
  •  70,000,000 people globally suffer from an eating disorder
Addiction (Alcohol, Drugs, Cigarettes)
  • 240,000,000 people globally suffer from addiction 

Market Opportunity (NUTRACEUTICAL)

 

Supplements for Brain Health & Cognitive Enhancement
  • Millions of people around the world are taking some form of   supplement (B12, B9, Omega 3, Vitamin D, Gingko Biloba and   others (4)) for brain health and/or cognitive enhancement   reasons
Global Market
  •  Global market size for these types of brain enhancing   supplements can reach $5.8 Billion US by 2023 (5)
 

Product Pipeline

 

Hard-shelled Capsules 

Product highlights:
  • Contain dry, powdered ingredients or miniature pellets made by e.g. processes of Extrusion or Spherization
    Often easier to swallow
    Protects sensitive ingredients
    Easily opened
    Reduced stomach irritation
    Unique ingredient combinations are possible
    Gelatin and vegetarian enclosure options
    Oil or fat-soluble nutrient delivery options
 

 
Oral Sprays

Advantages: 
  • Sublingual spray give faster onset and longer duration of action. It provides ease of administration to patients who refuse to swallow a tablet.
    There is no requirement of drug disintegration.
    Patients who experience dry mouth, the spray can be a better alternative, since the dissolution of the spray is not dependent upon patient’s saliva.
    Elimination of first pass metabolism, good mouth feels property.
    Low dosage provides high efficacy as hepatic first pass metabolism is avoided and also reduces the risk of side effects.
 

 
Gel Caps
Product Highlights:
  • Often easier to swallow
    Protects sensitive ingredients
    Easily opened
    Reduced stomach irritation
    Unique ingredient combinations are possible
    Gelatin and vegetarian enclosure options
    Oil or fat-soluble nutrient delivery options
 

 
Effervescents

Psilocybin has quality’s that could be uniquely paired with Effervescent formulations:
  • Increased uptake of Psilocin
    Rapid metabolization via sublingual absorption path way
    Easily dosed and titrated
    Easily packaged and produced
    Gentile on the gastrointestinal track
    Marketing advantages   
 

 
Oral Fast Dissolving Film
  • Proprietary oral fast-dissolving drug delivery system, fast psilocin, rapidly releases an expansive list of pharmaceuticals, emulsified psilocybin

    This permits API’s to enter the blood stream through a fast dose pathway without being degraded or modified by first pass metabolism in the liver.
     
    Sublingual and transmucosal transport of active molecules result from the rapid dissolution of Fast Strips combined with the proprietary technology. 
     
 
 
Volume:
Day Range:
Last Trade Time:
  • 1D
  • 1M
  • 3M
  • 6M
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  • 5Y
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