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Revive Therapeutics Ltd is a life sciences company focused on the research and development of therapeutics and diagnostics for infectious diseases, medical countermeasures, and rare disorders. They prioritize drug development to leverage regulatory incentives like Emergency Use Authorization and Orphan Drug designations. Currently, the company is exploring Bucillamine for potential treatments of nerve agent exposure and long COVID, along with advancing the development of Psilocybin-based therapeutics through various programs.
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) provided an update on their research study evaluating Bucillamine as a potential treatment for nerve agent exposure, conducted in partnership with Defence R&D Canada – Suffield Research Centre (DRDC). The first set of animal trials, including soman controls and bucillamine pretreated subjects, has been completed, with DRDC now analyzing GABA receptor downregulation data.
If the results prove significant, Revive and DRDC will discuss future development paths. Promising outcomes could lead to further studies for FDA and Health Canada approvals for Bucillamine's use in treating nerve agent or organophosphate pesticide poisoning, as well as exploring its potential for traumatic brain injury from concussive forces and viral infections.
Bucillamine, being a more effective antioxidant than n-acetylcysteine (NAC), could potentially provide increased efficacy against seizure activity while reducing anticoagulant and bleeding event risks associated with NAC. The research focuses on neuroprotection of GABA(A) receptors, important for current anticonvulsant therapies.
Revive Therapeutics (OTCQB: RVVTF) announced the publication of research demonstrating psilocybin's potential as a novel therapeutic approach for stroke treatment. The study, published in BMC Neuroscience, showed that psilocybin reduced brain infarction and improved locomotor behavior in stroke rats by regulating BDNF expression. The research supports the company's PCT application for using psilocybin to treat neurological brain injury and migraines, acquired from PharmaTher Holdings in February 2021. The company is developing novel delivery methods, including an oral thin-film and microneedle patch for psilocybin administration.
Revive Therapeutics (OTCQB: RVVTF) announced an update on their research study evaluating Bucillamine as a potential treatment for nerve agent exposure, conducted in partnership with Defence R&D Canada – Suffield Research Centre. The study is progressing with final results expected by end of 2024. If promising, results will determine further studies for FDA and Health Canada approvals for nerve agent and organophosphate pesticide poisoning treatments. Bucillamine, being a more effective antioxidant than n-acetylcysteine (NAC), could potentially provide increased efficacy against seizure activity while reducing anticoagulant and bleeding risks associated with NAC.
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) has provided an update on their research study evaluating Bucillamine as a potential treatment for nerve agent exposure. The study, conducted in partnership with Defence R&D Canada – Suffield Research Centre, is now expected to be completed in October 2024. If results are promising, further studies may be initiated to facilitate FDA and Health Canada approvals for Bucillamine's use in nerve agent or organophosphate pesticide poisoning.
The company is also exploring Bucillamine's potential in viral infections, including monkeypox (Mpox). Bucillamine, a cysteine derivative with two thiol groups, has shown to be 16 times more potent as a thiol donor than N-acetyl-L-cysteine (NAC), which has demonstrated efficacy in attenuating symptoms of respiratory viral infections. Revive emphasizes that no claims are being made about Bucillamine's ability to treat or cure Mpox or other infectious diseases at this time.
Revive Therapeutics, a specialty life sciences company, has provided an update on its research study evaluating Bucillamine for nerve agent exposure. This study, in collaboration with Defence R&D Canada – Suffield Research Centre, aims to find pharmacological treatments for nerve agent-induced brain injury. Control studies are underway, with data evaluation expected this month. Treatment studies will follow, and the research is slated to conclude by August 2024. The study compares Bucillamine, a potent antioxidant, to n-acetylcysteine (NAC) in enhancing the efficacy of GABA-mediating drugs like diazepam, potentially improving seizure control and reducing side effects. Promising results could pave the way for FDA and Health Canada approvals and may extend Bucillamine's use to treat traumatic brain injuries.
Revive Therapeutics announced updates on their Type C meeting with the FDA regarding a proposed clinical study of Bucillamine as a treatment for Long COVID. The FDA recommended submitting a new IND application, incorporating data from Revive's previous Phase 3 clinical trial on mild to moderate COVID-19. The FDA provided feedback on study design, population, and measures to assess therapeutic benefits. CEO Michael Frank expressed optimism about advancing Bucillamine's clinical development. The CDC estimates 7.5% of U.S. adults have Long COVID, costing up to $3.7 trillion. Revive aims to finalize their study protocol and submit the IND soon.
Results from a previous Phase 3 trial showed Bucillamine (600mg/day) prevented hospitalizations, while a lower dose (300mg/day) had one hospitalization compared to three in the placebo group. Bucillamine also improved oxygen saturation by 29.1% over placebo. These findings support further investigation of Bucillamine for Long COVID.
On June 10, 2024, Revive Therapeutics announced an update from the FDA regarding their Long COVID Diagnostic Product, the Revive LC POC Lateral Flow Test Kit. The FDA recommended the product follow the De Novo regulatory pathway, necessitating a clinical study for possible approval. CEO Michael Frank confirmed alignment with the FDA's recommendations and plans to discuss development and timelines with potential contract manufacturers. The product, developed under Revive Diagnostics, aims to detect long COVID via blood biomarkers identified by Dr. Douglas Fraser's research, recently published in Molecular Medicine. Currently, no FDA-approved diagnostic exists for long COVID, which affects at least 10% of SARS-CoV-2 infections and involves over 200 symptoms impacting multiple organ systems.