Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF) revealed that it has filed an application with the US Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for Bucillamine for the prevention of ischemia–reperfusion injury (IRI) during liver transplantation.
The Toronto-based life sciences company said that currently, there are no approved treatments available for IRI, a major complication of liver transplantation. “It is one of the leading causes for post-surgery hepatic dysfunction leading to an increased risk of postoperative morbidity and mortality,” it added.
According to the United Network for Organ Sharing, there were 8,906 liver transplants in 2020 and at the time of the ODD submission, there were 11,664 on the waiting list for a liver transplant. Although many therapeutic strategies have been shown to be effective in controlled experimental models, most have yet to reach human clinical trials. Revive believes the use of Bucillamine during liver transplants has the potential to be a “safe and effective approach” to limit or prevent IRI.
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Bucillamine, a cysteine derivative that contains two donatable thiol groups, in the context of IRI can replenish the thiol group in glutathione, thereby reactivating this defense against oxidant injury, said the company. In addition, Bucillamine appears to have anti-inflammatory effects unrelated to its antioxidant effect. Bucillamine also has the potential to improve graft function and patient outcome by preventing or lessening IRI, it added.
In a statement, Revive CEO Michael Frank said: “We are continuing to advance novel uses of Bucillamine not only as a treatment for infectious diseases, but also for rare conditions that have no treatment options such as IRI.”
“The FDA orphan drug application for Bucillamine as a potential solution in preventing IRI during liver transplantation and subsequently to other organ transplants complements our overall strategy of developing Bucillamine as a strong platform for other conditions,” he added.
The FDA grants Orphan drug status to products that treat rare diseases affecting fewer than 200,000 people in the United States. The designation would qualify Bucillamine for certain benefits, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, eligibility for orphan drug grants, and the waiver of the FDA’s new drug application filing fee of around $2,400,000.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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