Rezolute, Inc. Provides Updates in the Context of the COVID-19 Pandemic: Announces Resumption and US-Expansion of its Phase 2b Study in Congenital Hyperinsulinism
REDWOOD CITY, California, July 27, 2020 (GLOBE NEWSWIRE) -- Rezolute, Inc. (“Rezolute” or “the Company”) (OTCQB:RZLT), today provided an update on the status of the Company’s clinical programs in the context of the global COVID-19 pandemic (“Pandemic”), including its Phase 2b study for RZ358 (“RIZE”) in congenital hyperinsulinism (“CHI”) patients as well as a Phase 1 study for RZ402 in healthy volunteers.
In the Company’s quarterly report filed on Form 10-Q with the US Securities and Exchange Commission in May 2020 (“10-Q”), the Company reported that, as a result of the Pandemic, it paused the RIZE study after enrollment of the first patient. The study is being conducted globally at multiple study centers and as the Pandemic abates in different regions, the Company is resuming clinical activities including trial site initiations. The Company believes that patient enrollment will recommence by the end of September 2020. Further, as reported in the 10-Q, the Company believes that it will be able to complete the RIZE study in the second half of 2021.
In addition, in the first half of 2020, the Company had positive interactions with the US Food and Drug Administration (“FDA”). In June 2020, the Company announced that FDA granted Rezolute a Rare Pediatric Disease designation for RZ358, which qualifies the Company to receive a priority review voucher upon marketing approval for the drug. Further, the Company filed a protocol for the RIZE study with FDA and is now expanding the study to include US sites. Start-up activities are now underway at select US centers of excellence in CHI and the Company believes that patient enrollment may commence in the US in the first quarter of 2021, or sooner.
With respect to its program in Diabetic Macular Edema (RZ402), the Company is prepared to file an Investigational New Drug application (“IND”) with FDA. However, as a result of the present uncertainties associated with the Pandemic, the Company is deferring filing the IND until such time that the Company believes that its planned Phase 1 first in human study may be successfully and seamlessly executed. The Company anticipates initiating the clinical trial for RZ402 prior to the end of the first quarter of 2021, or sooner.
The Company’s current plans and expectations regarding the timing for its clinical programs are subject to change depending upon the continued evolution of the Pandemic in the US and globally.
About Rezolute, Inc.
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