Revive Therapeutics Announces Strategic Focus on Bucillamine for Infectious Diseases and Medical Countermeasures
Revive Therapeutics (OTCQB: RVVTF) has announced a strategic focus on advancing the clinical development of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties. The company is concentrating on three main programs:
1. Nerve Agent Exposure: In partnership with Defence R&D Canada, evaluating Bucillamine as a potential treatment for nerve agent exposure, with research expected to complete in October 2024.
2. Emerging Infections: Exploring Bucillamine's potential use in various viral infections, including monkeypox (Mpox).
3. Long COVID: Finalizing a Phase 2 study protocol for FDA submission by end of 2024, with expected approval in Q1-2025.
Revive has decided not to pursue the development of a Long COVID diagnostic product. The company emphasizes that no claims are being made about Bucillamine's ability to treat or cure these conditions at this time.
Revive Therapeutics (OTCQB: RVVTF) ha annunciato un focus strategico sull'avanzamento dello sviluppo clinico di Bucillamine, un farmaco orale a base di tiolo con proprietà anti-infiammatorie e antivirali. L'azienda si sta concentrando su tre programmi principali:
1. Esposizione agli Agenti Nervosi: In collaborazione con Defence R&D Canada, si sta valutando Bucillamine come potenziale trattamento per l'esposizione agli agenti nervosi, con ricerche che dovrebbero concludersi entro ottobre 2024.
2. Infezioni Emergenti: Si sta esplorando l'uso potenziale di Bucillamine in varie infezioni virali, incluso il vaiolo delle scimmie (Mpox).
3. Long COVID: Si sta finalizzando un protocollo per uno studio di Fase 2 per la presentazione all'FDA entro la fine del 2024, con approvazione prevista per il primo trimestre del 2025.
Revive ha deciso di non perseguire lo sviluppo di un prodotto diagnostico per il Long COVID. L'azienda sottolinea che al momento non vengono avanzate affermazioni sulle capacità di Bucillamine di trattare o curare queste condizioni.
Revive Therapeutics (OTCQB: RVVTF) ha anunciado un enfoque estratégico en avanzar en el desarrollo clínico de Bucillamine, un fármaco oral a base de tiól con propiedades antiinflamatorias y antivirales. La compañía se está concentrando en tres programas principales:
1. Exposición a Agentes Nerviosos: En asociación con Defence R&D Canada, se está evaluando Bucillamine como un posible tratamiento para la exposición a agentes nerviosos, con investigaciones que se espera concluyan en octubre de 2024.
2. Infecciones Emergentes: Explorando el uso potencial de Bucillamine en diversas infecciones virales, incluida la viruela del simio (Mpox).
3. Long COVID: Finalizando un protocolo de estudio de Fase 2 para la presentación a la FDA para finales de 2024, con aprobación esperada en el primer trimestre de 2025.
Revive ha decidido no seguir adelante con el desarrollo de un producto diagnóstico para Long COVID. La empresa enfatiza que no se están haciendo afirmaciones sobre la capacidad de Bucillamine para tratar o curar estas condiciones en este momento.
Revive Therapeutics (OTCQB: RVVTF)는 Bucillamine의 임상 개발을 진전시키기 위한 전략적 초점을 발표했습니다. Bucillamine은 항염증 및 항바이러스 특성을 가진 경구용 티올 기반 약물입니다. 회사는 세 가지 주요 프로그램에 집중하고 있습니다:
1. 신경 가스 노출: Defence R&D Canada와 협력하여 신경 가스 노출에 대한 잠재적 치료제로 Bucillamine을 평가하고 있으며, 연구는 2024년 10월에 완료될 예정입니다.
2. 신흥 감염: 다양한 바이러스 감염, 특히 원숭이두창(Mpox)에서 Bucillamine의 잠재적 사용을 탐색하고 있습니다.
3. 롱 COVID: 2024년 말까지 FDA 제출을 위한 2상 연구 프로토콜을 마무리하고 있으며, 2025년 1분기 승인 예정입니다.
Revive는 롱 COVID 진단 제품 개발을 추진하지 않기로 결정했습니다. 회사는 현재 Bucillamine이 이러한 상태를 치료하거나 치유할 수 있다는 주장 없이 강조하고 있습니다.
Revive Therapeutics (OTCQB: RVVTF) a annoncé un focus stratégique sur l'avancement du développement clinique de Bucillamine, un médicament oral à base de thiol avec des propriétés anti-inflammatoires et antivirales. L'entreprise se concentre sur trois programmes principaux :
1. Exposition aux Agents Nervaux: En partenariat avec Defence R&D Canada, Bucillamine est évalué comme un traitement potentiel pour l'exposition aux agents nerveux, avec des recherches devant se terminer en octobre 2024.
2. Infections Émergentes: Exploration de l'utilisation potentielle de Bucillamine dans diverses infections virales, y compris la variole simienne (Mpox).
3. Long COVID: Finalisation d'un protocole d'étude de Phase 2 pour soumission à la FDA d'ici la fin de 2024, avec une approbation attendue au premier trimestre 2025.
Revive a décidé de ne pas poursuivre le développement d'un produit de diagnostic pour le Long COVID. L'entreprise souligne qu'aucune affirmation n'est faite concernant la capacité de Bucillamine à traiter ou guérir ces conditions pour le moment.
Revive Therapeutics (OTCQB: RVVTF) hat einen strategischen Fokus auf die klinische Entwicklung von Bucillamine, einem oral verabreichten thiolhaltigen Medikament mit entzündungshemmenden und antiviralen Eigenschaften, angekündigt. Das Unternehmen konzentriert sich auf drei Hauptprogramme:
1. Exposition gegenüber Nervengiften: In Partnerschaft mit Defence R&D Canada wird Bucillamine als potenzielle Behandlung für die Exposition gegenüber Nervengiften evaluiert, wobei die Forschung voraussichtlich im Oktober 2024 abgeschlossen sein wird.
2. Aufkommende Infektionen: Es wird das potenzielle Einsatzgebiet von Bucillamine bei verschiedenen Virusinfektionen, einschließlich Affenpocken (Mpox), untersucht.
3. Long COVID: Ein Protokoll für eine Phase-2-Studie wird bis Ende 2024 zur FDA eingereicht, mit einer voraussichtlichen Genehmigung im ersten Quartal 2025.
Revive hat beschlossen, die Entwicklung eines diagnostischen Produkts für Long COVID nicht weiterzuverfolgen. Das Unternehmen betont, dass derzeit keine Ansprüche an die Fähigkeit von Bucillamine zur Behandlung oder Heilung dieser Erkrankungen erhoben werden.
- Strategic focus on Bucillamine development for multiple high-potential applications
- Ongoing research partnership with Defence R&D Canada for nerve agent exposure treatment
- Potential application in emerging viral infections like monkeypox
- Advancing Long COVID treatment research with FDA guidance
- Promising preliminary data from previous COVID-19 clinical trial
- Discontinuation of Long COVID diagnostic product development
- No immediate revenue generation from ongoing research projects
- Uncertain timeline for potential FDA approvals and commercialization
- Dependence on positive research outcomes for future development
TORONTO, Sept. 18, 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 infectious diseases and medical countermeasures, announced today its strategic focus on dedicating its resources to advancing the clinical development of Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties. The Company has decided not to pursue the development of the Long COVID diagnostic product.
The Company will be focusing on the following programs with Bucillamine for infectious diseases and medical countermeasures:
Nerve Agent Exposure
Nerve agents are chemicals that affect the nervous system. Nerve agents are highly toxic regardless of the route of exposure. The main chemical nerve agents that are man-made and manufactured for use in chemical warfare are sarin, soman, tabun and VX. These nerve agents are known to be present in military stockpiles. Exposure to nerve agents can occur due to chemical warfare or accidental release from a military storage facility. Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death.
Currently, in partnership with Defence R&D Canada – Suffield Research Centre (“DRDC”), an agency of the Canadian Department of National Defence, the Company is evaluating Bucillamine as a potential treatment for nerve agent exposure. 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. The overall objective of the research project is to investigate pharmacological means for neuroprotection of GABA(A) receptors, which are required for the effectiveness of currently fielded anticonvulsant therapies. Bucillamine and NAC will be evaluated to determine the effect on GABA(A) receptor endocytosis and the effect on diazepam effectiveness in terminating seizures. Any additional antioxidant effects on seizure activity and survival will also be assessed.
The results from this research partnership, if promising, will determine further studies to facilitate FDA and Health Canada approvals for the use of Bucillamine in nerve agents or organophosphate pesticide poisoning. Also, the Company may explore the potential of Bucillamine for traumatic brain injury caused by concussive or explosive forces.
The research study is progressing and is expected to be now completed in October 2024.
Emerging Infections
The results from the DRDC research study, if promising, may determine further studies for the potential use of Bucillamine in various viral infections, including monkeypox (“Mpox”).
In 2023, the World Health Organization released a Mpox fact sheet suggesting that severe cases of Mpox result in a number of conditions, including inflammation of the brain, heart, rectum, genital organs and urinary passages.1
A study in 2022 made the link between the administration of antioxidants and the improvement of virus-induced effects or to reduce viral replication yield. The suggestion that strong antioxidants such as N-acetyl-L-cysteine (“NAC”), butylated hydroxyanisole or Terameprocol could have an effect on Mpox viral infection in humans to ease severe symptoms.2 NAC has been shown to significantly attenuate clinical symptoms in respiratory viral infections in animals and humans, primarily via donation of thiols to increase antioxidant activity of cellular glutathione.3-6
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.7
Long COVID
The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms.8 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
Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID by leveraging the published research and data from its previous Phase 3 clinical trial. Per the results of the Type C meeting written responses received by the Company from the U.S. Food & Drug Administration (“FDA”) for the evaluation of a proposed clinical study of Bucillamine as a potential treatment for Long COVID, the FDA has recommended that the evaluation of Bucillamine for Long COVID be submitted as a new Investigational New Drug (“IND”) application and may cross-reference applicable sections from the Company’s current IND, that evaluated the safety and efficacy of Bucillamine in patients with mild to moderate COVID-19 in the Phase 3 clinical trial. In addition, the FDA provided valuable feedback on the appropriate design, study population, and safety and efficacy measures for assessing a therapeutic benefit in patients with Long COVID.
The Company is finalizing the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of 2024. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q1-2025.
As a background, 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 <
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.
The Company would like to make it clear that it is not making any express or implied claims that its product (Bucillamine) has the ability to treat, eliminate or cure long COVID, Monkeypox (Mpox) and/or other infectious diseases and medical countermeasures indications at this time.
About Revive Therapeutics Ltd.
Revive Therapeutics is a life sciences company focused on the research and development of therapeutics for infectious diseases and medical countermeasures. Revive prioritizes its drug development efforts to take advantage of several regulatory incentives awarded by the FDA, such as Emergency Use Authorization, Orphan Drug, Fast Track, and Breakthrough Therapy designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of nerve agent exposure and long COVID. Revive is also advancing the development of Psilocybin-based therapeutics through various programs. For more information, visit www.ReviveThera.com.
For more information, please contact:
Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “may”, “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company's management's discussion and analysis for the three and nine months ended March 31, 2024 ("MD&A"), dated May 28, 2024, which is available on the Company's profile at www.sedarplus.ca.
References:
- https://www.who.int/news-room/fact-sheets/detail/monkeypox
- Aydemir D, Ulusu NN. The possible importance of the antioxidants and oxidative stress metabolism in the emerging monkeypox disease: An opinion paper. Front Public Health. 2022 Oct 20;10:1001666.
- L. Carati et al, Attenuation of influenza-like symptomatology and improvement of cell-mediated immunity with long-term N-acetylcysteine treatment., Eur Respir J. 1997 Jul;10(7):1535-41).
- M Mata et al, 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;82(5):548-55.
- D Ungheri et al, Protective effect of n-acetylcysteine in a model of influenza infection in mice., Int J Immunopathol Pharmacol. 2000 Sep-Dec;13(3):123-128.
- RH Zhang 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).
- LD Horwitz, Bucillamine: a potent thiol donor with multiple clinical applications, Cardiovasc Drug Rev. 2003 Summer;21(2):77-90).
- “Nearly One in Five American Adults Who Have Had COVID-19 Still Have “Long COVID,” CDC, June 6, 2022, https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/20220622.htm
- “The Economic Cost of Long COVID: An Update,” David M. Cutler, Harvard University, July 22, 2022, https://scholar.harvard.edu/files/cutler/files/long_covid_update_7-22.pdf
FAQ
What is Revive Therapeutics' new strategic focus for Bucillamine?
When is the nerve agent exposure research with DRDC expected to complete?
What is the timeline for Revive's Long COVID treatment study with Bucillamine?
Has Revive Therapeutics (RVVTF) discontinued any projects?
What were the results of Revive's previous COVID-19 clinical trial with Bucillamine?
