Adial Pharmaceuticals, Inc., announced that Purnovate, Inc., a subsidiary of Adial focused on developing novel molecules targeting the adenosine receptors for the treatment of major unmet medical needs, achieved positive in-vivo data from its study with mice treated with Purnovate’s PNV-6005 as a potential treatment for inflammatory bowel diseases.
PNV-6005 is a selective adenosine 2A receptor agonist designed to have anti-inflammatory properties and protective effects against colitis and other inflammatory bowel diseases (IBD). In the study, PNV-6005 demonstrated statistically significant effect against both primary study endpoints, which are pre-clinical endpoints expected to indicate potential efficacy against ulcerative colitis in humans. Specially, PNV-6005 (i) significantly prevented weight loss as compared to the control group (greater than 50% inhibition of weight loss) and (ii) significantly prevented colon damage as evidenced by reduction of shortening of colon lengths in the PNV-6005 treated group (almost total prevention), as well as a decrease in inflammation as assessed histologically.
The study was conducted by Dr. Peter Ernst, DVM, PhD, Professor of Pathology at the University of California San Diego (UC San Diego), an expert in the fields of immunology, inflammation and infectious diseases.
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Study Design
- The study utilized a DSS- induced colitis model, which is widely used because of its simplicity and similarities with human ulcerative colitis
- PNV-6005 was administered intraperitoneally twice a day at 6µg/kg dose for 7 days
- DSS was administrated at 4% concentration via drinking water
- The study included four groups of 5 mice: (i) one group with normal drinking water; (ii) one group with DSS 4% volume concentration in drinking water; and (iii) two treated groups receiving PNV6005 intraperitoneal injections
The positive results follow a recent research collaboration agreement between Purnovate and UC San Diego, a leading education and research university, to evaluate the Company’s proprietary adenosine analogs as a potential treatment for inflammatory diseases, including IBD and infectious diseases where a large immune response (i.e., cytokine storm) plays a significant role.
Dr. Ernst stated, “We are encouraged by these results, which demonstrate both in-vivo efficacy and the ability of Purnovate’s adenosine compounds to effectively address the historical challenges of solubility and biodistribution. We look forward to further advancing this research in ulcerative colitis as well as broader IBD indications and other inflammatory conditions.”
William Stilley, CEO of Purnovate, stated, “We appreciate the support of Dr. Ernst and UC San Diego in supporting this important study, and look forward to advancing PNV-6005 towards first-in-human clinical trials. Ulcerative colitis is the most common form of IBD and causes inflammation and ulcers in the digestive tract, affecting an estimated 1 million people in the U.S. alone. According to QY Research Medical, the ulcerative colitis market was valued at $6.2 billion in 2020 and it is expected to reach $10.8 billion by 2030. In addition to advancing PNV-6005 for ulcerative colitis and IBD, we believe this research reinforces the broad potential of our Purnovate adenosine platform for other inflammatory conditions.”
“These additional data strengthen our belief in the potential for our Purnovate platform and diverse opportunities,” said Cary Claiborne, CEO of Adial. “We will continue to provide updates on our progress with Purnovate as we advance the first drug candidates from this program toward clinical development. Furthermore, we see good synergies between Adial’s work in bringing AD04 toward the market and that of Purnovate, with a focus on building upon our addiction and pain treatment pipeline.”
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