Revive Therapeutics Announces Update on R&D Focus on Bucillamine for Infectious Diseases and Medical Countermeasures
Revive Therapeutics (OTCQB: RVVTF) has provided an update on its R&D focus for Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties. The company is pursuing two main programs:
1. Medical Countermeasures: In partnership with Defence R&D Canada, evaluating Bucillamine as a treatment for nerve agent exposure. The research study is expected to complete in February 2025.
2. Infectious Diseases: Targeting Long COVID as initial indication. Previous Phase 3 trial data showed Bucillamine demonstrated 29.1% improvement over placebo in time to normal oxygen saturation for patients with oxygen saturation <96% at baseline. The company plans to submit a Phase 2 study protocol to FDA by Q1-2025, with expected approval in Q2-2025.
Additionally, the company disclosed a consent judgment regarding an arbitration award of €301,806.5 and USD$160,800 plus costs, with enforcement delayed until May 22, 2025.
Revive Therapeutics (OTCQB: RVVTF) ha fornito un aggiornamento sul suo focus di R&D per Bucillamine, un farmaco orale a base di tiolo con proprietà antinfiammatorie e antivirali. L'azienda sta perseguendo due programmi principali:
1. Contromisure Mediche: In collaborazione con Defence R&D Canada, sta valutando Bucillamine come trattamento per esposizione a agenti nervini. Si prevede che lo studio di ricerca si concluda a febbraio 2025.
2. Malattie Infettive: Focalizzandosi sul Long COVID come indicazione iniziale. I dati del precedente studio di fase 3 hanno mostrato che Bucillamine ha dimostrato un miglioramento del 29,1% rispetto al placebo nel tempo necessario per raggiungere la saturazione di ossigeno normale per i pazienti con saturazione di ossigeno <96% all'inizio dello studio. L'azienda prevede di presentare un protocollo di studio di fase 2 alla FDA entro il Q1-2025, con un'approvazione attesa per il Q2-2025.
Inoltre, l'azienda ha divulgato un giudizio di consenso riguardante un premio di arbitrato di €301.806,5 e USD$160.800 più costi, con l'esecuzione rinviata fino al 22 maggio 2025.
Revive Therapeutics (OTCQB: RVVTF) ha proporcionado una actualización sobre su enfoque de I+D para Bucillamina, un medicamento oral a base de tiol con propiedades antiinflamatorias y antivirales. La empresa está llevando a cabo dos programas principales:
1. Contramedidas Médicas: En asociación con Defence R&D Canada, evaluando Bucillamina como tratamiento para la exposición a agentes nerviosos. Se espera que el estudio de investigación se complete en febrero de 2025.
2. Enfermedades Infecciosas: Apuntando al Long COVID como indicación inicial. Los datos del anterior ensayo de fase 3 mostraron que Bucillamina demostró una mejora del 29,1% sobre el placebo en el tiempo hasta alcanzar la saturación normal de oxígeno para los pacientes con saturación de oxígeno <96% al inicio. La empresa planea presentar un protocolo de estudio de fase 2 a la FDA para el primer trimestre de 2025, con aprobación esperada para el segundo trimestre de 2025.
Además, la empresa reveló un juicio de consentimiento relacionado con un laudo de arbitraje de €301.806,5 y USD$160.800 más costos, con la ejecución aplazada hasta el 22 de mayo de 2025.
Revive Therapeutics (OTCQB: RVVTF)는 항염 및 항바이러스 특성을 가진 경구용 티올 기반 약물인 부실라민에 대한 연구 및 개발(R&D) 초점에 대한 업데이트를 제공했습니다. 이 회사는 두 가지 주요 프로그램을 추진하고 있습니다:
1. 의료 대응책: 캐나다 국방 연구 및 개발과 협력하여 신경 작용제 노출에 대한 치료제로 부실라민을 평가하고 있습니다. 연구는 2025년 2월에 완료될 것으로 예상됩니다.
2. 전염병: 장기 COVID를 초기 징후로 목표로 하고 있습니다. 이전 3상 시험 데이터는 부실라민이 기저선에서 산소 포화도가 <96%인 환자에게 정상 산소 포화도에 도달하는 데 있어 위약에 비해 29.1% 개선된 것으로 나타났습니다. 이 회사는 2025년 1분기까지 FDA에 2상 연구 프로토콜을 제출할 계획이며, 2025년 2분기에 승인이 예상됩니다.
또한, 이 회사는 €301,806.5 및 USD$160,800와 비용에 대한 중재 판정에 대한 동의 판결을 공개했으며, 집행은 2025년 5월 22일까지 연기되었습니다.
Revive Therapeutics (OTCQB: RVVTF) a fourni une mise à jour sur son axe R&D concernant la Bucillamine, un médicament oral à base de thiol avec des propriétés anti-inflammatoires et antivirales. La société poursuit deux programmes principaux :
1. Contre-mesures médicales : En partenariat avec Defence R&D Canada, évaluant la Bucillamine comme traitement pour l'exposition aux agents neurotoxiques. L'étude de recherche devrait se terminer en février 2025.
2. Maladies infectieuses : Ciblant le Long COVID comme indication initiale. Les données de l'essai de phase 3 précédent ont montré que la Bucillamine présentait une amélioration de 29,1 % par rapport au placebo pour le temps nécessaire pour atteindre une saturation en oxygène normale chez les patients avec une saturation <96 % au départ. La société prévoit de soumettre un protocole d'étude de phase 2 à la FDA d'ici le premier trimestre 2025, avec une approbation prévue au deuxième trimestre 2025.
De plus, la société a divulgué un jugement de consentement concernant une décision d'arbitrage de 301.806,5 € et 160.800 USD plus les coûts, avec l'exécution différée jusqu'au 22 mai 2025.
Revive Therapeutics (OTCQB: RVVTF) hat ein Update zu seinem Fokus auf Forschung und Entwicklung für Bucillamin, ein oral eingenommener Thiol-basiert Arznei mit entzündungshemmenden und antiviralen Eigenschaften, bereitgestellt. Das Unternehmen verfolgt zwei Hauptprogramme:
1. Medizinische Gegenmaßnahmen: In Zusammenarbeit mit Defence R&D Canada wird Bucillamin als Behandlung bei Nervengift-Exposition evaluiert. Die Forschungsstudie soll im Februar 2025 abgeschlossen sein.
2. Infektionskrankheiten: Die Ausrichtung auf Long COVID als erste Indikation. Die Daten aus der vorherigen Phase-3-Studie zeigten, dass Bucillamin eine Verbesserung von 29,1 % im Vergleich zum Placebo in der Zeit bis zur normalen Sauerstoffsättigung bei Patienten mit einer Sauerstoffsättigung <96% zu Beginn erreichte. Das Unternehmen plant, ein Protokoll für eine Phase-2-Studie bis zum ersten Quartal 2025 bei der FDA einzureichen, mit einer erwarteten Genehmigung im zweiten Quartal 2025.
Darüber hinaus gab das Unternehmen ein Einverständnisurteil bezüglich eines Schiedsgerichtspreises von €301.806,5 und USD$160.800 zuzüglich Kosten bekannt, dessen Vollstreckung bis zum 22. Mai 2025 verschoben wurde.
- Bucillamine showed 29.1% improvement over placebo in oxygen saturation recovery
- No hospitalizations occurred in the Bucillamine large dose group (600mg/day) in COVID-19 trial
- Obtained FDA guidance for Long COVID clinical trial pathway
- Company faces significant financial liability from arbitration award (€301,806.5 and USD$160,800)
- Phase 2 study for Long COVID still pending FDA approval
- Current research still in early stages with no guaranteed outcomes
TORONTO, Feb. 03, 2025 (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 an update on its research and development focus on Bucillamine.
Bucillamine, an oral thiol-based drug with anti-inflammatory and antiviral properties, 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 N-Acetyl-L-Cysteine (“NAC”).1
The Company will be focusing on the following programs with Bucillamine:
Medical Countermeasures
Revive is targeting nerve agent exposure as its initial indication for its medical countermeasures program. 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 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, and for concussion.
The research study is progressing and is expected to be now completed in February 2025.
Infectious Diseases
Revive is targeting Long COVID as its initial indication for its infectious disease program. The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms.2 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
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.
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 continues to finalize the proposed Phase 2 study protocol for submission to the FDA. It expects to submit it by the end of Q1-2025. The proposed Phase 2 clinical study is expected to be approved by the FDA in Q2-2025.
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, and/or other infectious diseases and medical countermeasures indications at this time.
The Company also announces that in connection with an award issued by the ICC International Court of Arbitration on May 28, 2024, Revive has agreed to a consent judgement in the Ontario Superior Court with one of its service providers. The consent judgment recognizes the award in the amount of Euro
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 months ended September 30, 2024 ("MD&A"), dated November 29, 2024, which is available on the Company's profile at www.sedarplus.ca.
References:
- 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
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