Non-clinical safety profile and pharmacodynamics of two formulations of the anti-sepsis drug candidate Rejuveinix

Uckun, F.; orhan, c.; Powell, J.; Sahin, E.; Ozercan, I.; Volk, M.; Sahin, K.

doi:10.1101/2021.01.03.425139

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bioRxiv · 10.1101/2021.01.03.425139

Non-clinical safety profile and pharmacodynamics of two formulations of the anti-sepsis drug candidate Rejuveinix

Uckun, F.·orhan, c.·Powell, J.·Sahin, E.·Ozercan, I.·Volk, M.·Sahin, K.

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Abstract

Here, we demonstrate that the two distinct formulations of our anti-sepsis drug candidate Rejuveinix (RJX) have a very favorable safety profile in Wistar Albino rats at dose levels comparable to the projected clinical dose levels. 14-day treatment with RJX-P or RJX-B similarly elevated the day 15 tissue levels of the antioxidant enzyme superoxide dismutase (SOD) as well as ascorbic acid in both the lungs and liver in a dose-dependent fashion. The activity of SOD and ascorbic acid levels were significantly higher in tissues of RJX-P or RJX-B treated rats than vehicle-treated control rats (p <0.0001). There was no statistically significant difference between tissues SOD activity or ascorbic acid levels of rats treated with RJX-P vs. rats treated with RJX-B (p >0.05). The observed elevations of the SOD and ascorbic acid levels were transient and were no longer detectable on day 28 following a 14-day recovery period. These results demonstrate that RJX-P and RJX-B are bioequivalent relative to their pharmacodynamic effects on tissue SOD and ascorbic acid levels.

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Uckun, F., orhan, c., Powell, J., Sahin, E., Ozercan, I., Volk, M., Sahin, K.. 2021-01-04. Non-clinical safety profile and pharmacodynamics of two formulations of the anti-sepsis drug candidate Rejuveinix. https://doi.org/10.1101/2021.01.03.425139

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