Phase 2 study finds addition of nutritional protocol to standard of care reduces recovery time to 6.6 days from 9.3 in mild-to-moderate COVID-19 patients
ChromaDex Corp. (NASDAQ:CDXC) today announced that results from the study "Combined metabolic cofactor supplementation accelerates recovery in mild-to-moderate COVID-19" were published on the open access preprint publication server medRxiv.org. The Phase 2 study reported patients with mild-to-moderate COVID-19 experienced a 29% reduction in recovery time when receiving the standard of care in combination with a nutritional protocol including nicotinamide riboside (NR). The additional nutritional support was designed to promote healthy mitochondrial function and reduced average recovery time to 6.6 days in comparison to average placebo recovery time of 9.3 days. COVID-19 has been associated with metabolic conditions such as hypertension, high blood sugar, obesity, high triglycerides and low HDL cholesterol, putting individuals with these conditions at greater risk for worse outcomes. The patients receiving the nutritional protocol consisting of nicotinamide riboside (NR), L-serine, N-acetyl-L-cysteine (NAC), and L-carnitine tartrate also experienced a significant improvement in liver function.
"This clinical study on nearly 100 subjects resulted in significantly speedier recovery time for COVID-19 patients and builds upon the existing research," said ChromaDex Chief Executive Officer Rob Fried. "There are currently 11 published human clinical studies showing the safety and efficacy of NR in various indications and several dozen more in the works including studies specifically focused on COVID-19."
The research was conducted in partnership with ScandiBio Therapeutics, a biotechnology company originating from the Swedish national infrastructure Science for Life Laboratory. The phase 2 clinical study was led by Dr. Adil Mardinoglu and took place at the Umraniye Teaching and Research Hospital, University of Health Sciences, Istanbul, Turkey. ChromaDex provided NR (patented nicotinamide riboside) for the study, conducted through the ChromaDex External Research Program (CERP).
In the open-label, randomized, placebo-controlled, Phase 2 study, 100 outpatient (ambulatory) patients with mild-to-moderate COVID-19 were randomly assigned on a 3:1 basis to receive hydroxychloroquine, which is the standard of care in Turkey, in combination with either a nutritional protocol (combined metabolic cofactors supplementation) or placebo twice per day beginning approximately 24-48 hours after diagnosis. Patients received the standard of care for five days and either the nutritional protocol or placebo for 14 days, with plasma samples collected on day 0 and day 14 to assess biomarkers. Key findings for the 93 patients completing the study include:
- The combination treatment significantly reduced average recovery time compared with the placebo group (6.6 days vs 9.3 days, respectively, an improvement of just over 29%).
- There was a significant reduction in plasma ALT, AST and LDH levels for the combination treatment on day 14 compared to day 0.
- Adverse events were uncommon, benign, and self-limiting.
"This research builds upon a broader understanding of the importance of mitochondrial health in response to metabolic stress. Given the scientific understanding that people with various metabolic conditions have a greater risk of poor outcomes following a COVID-19 diagnosis, it is important to understand the potential benefit of mitochondrial health in aiding patient recovery," said principal study investigator Dr. Mardinoglu. "The insights provided by this data warrant further clinical study of this nutrient protocol in combination with standard of care to reduce recovery time from COVID-19. We look forward to the initiation of a Phase 3 study in the near future."
The new data build on a breadth of published clinical research supporting the safety and efficacy of nicotinamide riboside across various therapeutic and functional areas. Currently, ChromaDex is exploring the potential impact of nicotinamide riboside on a variety of age-related and metabolic health declines, ranging from cardiovascular health to Alzheimer's disease, with a number of preclinical and clinical studies underway. Dr. Charles Brenner, the discoverer of the vitamin activity of nicotinamide riboside, Chief Scientific Advisor at ChromaDex, and Alfred E Mann Chair of Diabetes & Cancer Metabolism at City of Hope, led research that demonstrated promising anti-viral effects of nicotinamide riboside in a preclinical coronavirus cell model.
"This is a positive and timely clinical trial with a powerful topline result showing accelerated recovery of Turkish COVID-19 patients treated with a nutrient protocol including 2 grams of daily NR," said Dr. Brenner. "The findings of this study are consistent with the results of previous preclinical research in which we've seen beneficial effects on circulating liver enzymes, anti-inflammatory effects, and boosted innate antiviral immune defenses."
ChromaDex, the exclusive licensee of Dr. Charles Brenner's patented NR, has invested over $35 million in investigating, manufacturing and offering NR in the form of Niagen and has secured more than 20 patents. ChromaDex has demonstrated the safety and efficacy of Niagen in 11 published human trials (and over 20 additional ongoing studies further evaluating its safety and efficacy) and has achieved government regulatory acceptance in the United States, Canada, the European Union, and Australia.
For additional information about ChromaDex, please visit www.chromadex.com.