Revive Therapeutics Applies to FDA for Orphan Drug Designation for Treatment of Autoimmune Hepatitis | Diskussion im Forum

[Shanghai2006]

Revive Therapeutics Provides Update on Psilocybin Clinical Study for Methamphetamine Use Disorder
PRESS RELEASE GlobeNewswire
Apr. 2, 2024, 07:30 AM

TORONTO, April 02, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s clinical study (the “Study”) (NCT05322954) evaluating the safety and feasibility of oral psilocybin as a potential treatment for methamphetamine use disorder conducted under an investigator-initiated IND at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy.

The Study has enrolled nearly 50% of its intended study sample, with initial efficacy being encouraging. The clinical data generated from the Study may provide proprietary and valuable information on the safety, efficacy and dosing of oral psilocybin to support a potential pivotal clinical study and commercial initiatives in countries, such as Australia, where psilocybin can be available to licensed psychiatrists to prescribe for certain conditions. In addition, the Company will have exclusive access to key intellectual property from this Study to support commercial and development initiatives, including future clinical studies for its proposed novel delivery of psilocybin by a proprietary microneedle patch under its research collaboration agreement with PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) for neuropsychiatric disorders.

Methamphetamine use disorder is a chronic relapsing condition associated with substantial mental, physical, and social harms and increasing rates of mortality. Contingency management and psychotherapy interventions are the mainstays of treatment but are modestly effective with high relapse rates, while pharmacological treatments have shown little to no efficacy. At present, there are no approved medications to treat methamphetamine use disorder. Psilocybin-assisted psychotherapy is emerging as a promising treatment for a range of difficult-to-treat conditions, including substance use disorders; however, no studies have yet been published looking at psilocybin-assisted psychotherapy in the treatment of methamphetamine use disorder.

https://markets.businessinsider.com/news/stocks/revive-thera…

[Shanghai2006]

Revive Therapeutics Submits Type C Meeting Request Package to FDA for Clinical Study of Bucillamine to Treat Long COVID
Revive Therapeutics Ltd. Wed, March 27, 2024 at 8:08 PM GMT+7

https://finance.yahoo.com/news/revive-therapeutics-submits-t…

TORONTO, March 27, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today that it has submitted a Type C meeting request package to the U.S. Food & Drug Administration (“FDA”) for the evaluation of a proposed clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long-term COVID. Following the submission of the Type C meeting request package, the Company expects to hear from the FDA on a firm date for the meeting.

The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1. David Cutler, PhD, a professor of economics at Harvard University, estimates in a recent research disclosure that the total economic cost of long COVID could be as much as $3.7 trillion2.

Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID. The Company is advancing the clinical development of Bucillamine by leveraging the published research and data from its previous Phase 3 clinical trial (the “Study”) and is finalizing the regulatory and clinical package that includes a proposed clinical study for long COVID to present to the FDA.

On July 6, 2023, the Company announced the results of its Study evaluating the safety and efficacy of oral Bucillamine in patients with mild to moderate COVID-19. Under the Study’s primary endpoint, the proportion of patients meeting a composite endpoint of hospitalization or death from time of first dose through Day 28 following randomization, there were no deaths and four hospitalizations, of which three were from the placebo arm and one from the Bucillamine low dose group (300mg/day). No hospitalizations occurred in the Bucillamine large dose group (600mg/day). The Company evaluated certain Study endpoints, including the COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation). Based on preliminary analyses, the data demonstrated that for patients with oxygen saturation <96% at baseline, Bucillamine had a 29.1% improvement over placebo in time to normal oxygen saturation (SpO2). Additional analyses of the Study data may suggest Bucillamine’s potential for long COVID.

A study titled “Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry” showed that thiol-based drugs, like Bucillamine, decrease the binding of SARS-CoV-2 spike protein to its receptor, decrease the entry efficiency of SARS-CoV-2 spike pseudotyped virus, and inhibit SARS-CoV-2 live virus infection. These findings uncovered a vulnerability of SARS-CoV-2 to thiol-based drugs and provided a rationale to test thiol-based drugs such as Bucillamine as novel treatments for COVID-19.

[Shanghai2006]

Revive Therapeutics Ltd.: Revive Therapeutics To Submit Type C Meeting Request with FDA for Bucillamine to Treat Long COVID
PRESS RELEASE GlobeNewswire
Mar. 19, 2024, 07:00 AM

https://markets.businessinsider.com/news/stocks/revive-thera…

Totgeglaubte ....

Auszug:
... FDA advised the Company to submit a Type C meeting request to discuss evaluating a proposed Phase 2 clinical study of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID. The Company expects to submit the Type C meeting request by next week.
...

[Shanghai2006]

Revive Therapeutics Explores the Use of Bucillamine for Long COVID

TORONTO, Feb. 01, 2024 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today its initiative in Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, as a potential treatment for long COVID. The Company aims to advance the clinical development of Bucillamine by leveraging the published research and existing data from its previous Phase 3 clinical trial (the “Study”) and is preparing a clinical package that includes a proposed Phase 2/3 clinical protocol for long COVID to present to the FDA and international health regulatory bodies.

[Shanghai2006]

Revive Therapeutics Successfully Completes Development of a Novel Lyophilized Formulation of Bucillamine
January 10, 2024

TORONTO, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that it has completed the formulation development work of the Company’s next-generation lyophilized formulation of Bucillamine (“New Bucillamine”) conducted at the University of Waterloo. The New Bucillamine has the potential to unlock the therapeutic utility of Bucillamine for treating public health medical emergencies, including pandemic influenza, emerging infectious diseases, and medical countermeasure incidents and attacks.

“We are now entering into the next phase of development with our next-generation lyophilized formulation of Bucillamine that has the potential to treat unmet medical needs and public health medical emergencies, and we expect to evaluate it in a clinical study this year,” said Michael Frank, CEO of Revive.

Key research findings and observations include:
- Lyophilization of Bucillamine enhances solubility 2.7x compared to standard solution of Bucillamine;
- Inclusion of lyophilization in the Bucillamine formulation approach can result in an ability to increase Bucillamine delivery per dosing unit; and
- Inclusion of lyophilization in the Bucillamine formulation approach offers a simple way to create a parenteral injection product with minimal formulation additives.

With this achievement, Revive will work with Attwill Medical Solutions LP in the technology transfer and prepare plans for potential clinical and commercial development in support of specific initiatives that the Company is involved with, such as the continuation of the research project the Company has with the Defence R&D Canada - Suffield, an agency of the Canadian Department of National Defence, to evaluate Bucillamine as a potential treatment for nerve agent exposure. Also, the Company may explore the New Bucillamine as a potent antioxidant and anti-inflammatory, for rare inflammatory disorders such as ischemia-reperfusion injury (i.e. organ transplantation), which the FDA granted orphan drug designation for in 2022. The Company expects to have New Bucillamine ready for clinical evaluation in 2024.

https://finance.yahoo.com/news/revive-therapeutics-successfu…

[Shanghai2006]

Revive Therapeutics Ltd.: Revive Therapeutics Announces Results of Annual General and Special Meeting of Shareholders
TORONTO, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. ("Revive" or the "Company") (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce the results of its annual general and special meeting of shareholders held Tuesday, December 19, 2023 (the "Meeting") in Toronto, Ontario. All matters presented to the shareholders of the Company (the "Shareholders") for approval as set out in the Company's Notice of Meeting and Information Circular, dated November 10, 2023 respectively, were approved by an overwhelming majority of votes cast at the Meeting. Of the 357,646,841 shares issued and outstanding on the record date for the Meeting, 143,297,862 shares, being 40% of the shares, were voted.

Shareholders of the Company re-elected Michael Frank, Joshua Herman, William L.C. Jackson, Andrew S. Lindzon and Christian Scovenna (the "Board of Directors") for the ensuing year.

The Shareholders of the Company re-appointed Clearhouse LLP, Chartered Professional Accountants, as the Company's auditors for the ensuing year, and authorized the Board of Directors to fix the remuneration to be paid to the auditors.

In addition, the Shareholders approved the Company's 10% rolling stock option plan (the "Option Plan"), whereby the Company is authorized to issue options under the Option Plan to acquire up to 10% of the then issued and outstanding common shares in the capital of the Company at the time of grant.

Following the Meeting, the Board of Directors re-appointed Michael Frank as Executive Chairman and Chief Executive Officer, and Carmelo Marrelli as Chief Financial Officer and Corporate Secretary (the "Management").

https://www.finanznachrichten.de/nachrichten-2023-12/6098330…

[Shanghai2006]

Revive Therapeutics Enters into Agreement with Defence Research and Development Canada for Evaluating Bucillamine for Nerve Agent Exposure
Oct 17, 2023

TORONTO, Oct. 17, 2023 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, today announced that it has entered into an agreement with Defence R&D Canada – Suffield Research Centre (“DRDC”), an agency of the Canadian Department of National Defence, to evaluate Bucillamine as a potential treatment for nerve agent exposure. The DRDC will fund the research project, which is expected to begin in early Q1-2024.

DRDC is investigating pharmacological compounds that can mitigate nerve agent induced brain injury. Recent studies have shown that antioxidant compounds such as n-acetylcysteine (“NAC”) could be beneficial in limiting seizure activity and improving the anticonvulsant efficacy of GABA-mediating drugs such as diazepam. Bucillamine is a significantly more effective antioxidant than NAC and has the potential to provide increased efficacy against seizure activity while limiting the anticoagulant and bleeding event liability observed with NAC. If promising, further studies will be conducted to facilitate Health Canada approval for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning and potentially begin initial studies for efficacy against mild traumatic brain injury caused by concussive or explosive forces.

“We are excited to work with the DRDC in evaluating Bucillamine as a potential therapeutic for nerve agent exposure and validating the novel uses and formulations of Bucillamine for public health medical emergencies, including pandemic influenza, emerging infectious diseases, and medical countermeasure incidents and attacks,” said Michael Frank, CEO of Revive.

https://revivethera.com/2023/10/revive-therapeutics-enters-i…

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https://www.globenewswire.com/en/news-release/2023/08/22/272…
So. Weiter gehts ?😅

Revive Therapeutics kündigt die Einleitung einer neuartigen Bucillamine-Formulierung an

Bucillamine-Formulation-Development.html?fbclid=IwAR1-0Wtwv7uijfVr02Q3zPAVWohBmIhquESds0mbAGXz-VzmJGpaAuOq8Vk_aem_AZ3_ek5zGThvlQUjNfQOCGQwgFx1_fdeftJFse3mo2QeZqaP4gomL7tW11wdUN8X-zY

[Pixel_Muc]

Antwort auf Beitrag Nr.: 74.229.684 von Shanghai2006 am 30.07.23 07:25:27

Was denn das jetzt auf einmal? Scheint ja ein Wundermittel zu sein was aber anscheinend keiner will.

[Shanghai2006]

Link:
https://stockhouse.com/news/press-releases/2023/07/28/revive…