Revive Therapeutics Focuses on Bucillamine for Infectious Diseases and Countermeasures

TORONTO, Sept. 18, 2024 - Revive Therapeutics Ltd. ("Revive" or the "Company"), a specialty life sciences firm dedicated to the research and development of therapeutics for infectious diseases and medical countermeasures, has announced a strategic shift towards advancing the clinical development of Bucillamine, an oral drug with anti-inflammatory and antiviral properties. Consequently, the Company will no longer pursue the development of a Long COVID diagnostic product.

Revive is concentrating its efforts on exploring Bucillamine for various applications in infectious diseases and medical countermeasures, beginning with nerve agent exposure. Nerve agents, such as sarin, soman, tabun, and VX, are highly toxic chemicals that disrupt the nervous system and pose severe health risks, including chest tightness, excessive salivation, abdominal cramps, and potentially death. These agents are typically found in military stockpiles and can cause exposure through chemical warfare or accidental release.

In collaboration with Defence R&D Canada – Suffield Research Centre (DRDC), Revive is evaluating Bucillamine as a treatment for nerve agent exposure. DRDC is investigating pharmacological compounds that mitigate brain injury induced by nerve agents. Antioxidant compounds, like n-acetylcysteine (NAC), have shown potential in reducing seizure activity and improving the efficacy of GABA-mediating drugs like diazepam. Bucillamine, a more potent antioxidant than NAC, could enhance seizure management while reducing anticoagulant and bleeding risks associated with NAC. The aim of the research is to explore neuroprotection methods for GABA(A) receptors, essential for current anticonvulsant therapies. Bucillamine and NAC will be tested for their effects on GABA(A) receptor endocytosis and diazepam’s effectiveness in terminating seizures. The results may lead to further studies to secure FDA and Health Canada approvals for Bucillamine’s use in nerve agent or organophosphate pesticide poisoning. Additionally, Revive may investigate Bucillamine for traumatic brain injuries from concussive or explosive forces. The study is expected to conclude in October 2024.

Revive is also examining the potential of Bucillamine in treating emerging infections. Should the DRDC study yield promising results, further exploration for Bucillamine’s application in viral infections like monkeypox (Mpox) will proceed. The World Health Organization notes that severe Mpox cases can lead to conditions such as brain, heart, and genital inflammation. Research has linked antioxidant administration to improved outcomes in viral infections. NAC, in particular, has shown efficacy in reducing clinical symptoms in respiratory viral infections. Bucillamine, a cysteine derivative with two thiol groups, is significantly more potent than NAC as a thiol donor and has been prescribed for rheumatoid arthritis in Japan and South Korea for over 30 years.

In the context of Long COVID, the CDC estimates that 7.5% of U.S. adults experience long COVID symptoms, with an economic burden potentially reaching $3.7 trillion. Revive is leveraging data from a previous Phase 3 clinical trial to explore Bucillamine as a treatment for long COVID. The U.S. FDA has recommended submitting an Investigational New Drug (IND) application for evaluating Bucillamine in long COVID. The Company is finalizing a Phase 2 study protocol, expected for FDA submission by the end of 2024, with anticipated approval in Q1-2025.

Previously, a study evaluated Bucillamine’s safety and efficacy in mild to moderate COVID-19 patients. The study found no deaths and fewer hospitalizations in the Bucillamine treatment groups compared to the placebo group. Preliminary data showed significant improvements in oxygen saturation for patients treated with Bucillamine. Further analysis suggested Bucillamine’s potential for long COVID treatment.

Additionally, research titled “Thiol-based drugs decrease binding of SARS-CoV-2 spike protein to its receptor and inhibit SARS-CoV-2 cell entry” demonstrated that thiol-based drugs, including Bucillamine, could inhibit the SARS-CoV-2 virus. These findings support the rationale for testing Bucillamine as a novel COVID-19 treatment.

Revive Therapeutics Ltd. continues to focus on developing therapeutics for infectious diseases and medical countermeasures, capitalizing on regulatory incentives from the FDA. The Company is progressing with Bucillamine for nerve agent exposure and long COVID, while also advancing Psilocybin-based therapeutics through various programs.