Adial Pharmaceuticals Announces Positive InVivo Nonclinical Data With Purnovates PNV6005 As A Potential Treatment For Ulcerative Colitis
PNV-6005 significantly reduced both weight loss and colon damage in animal models of ulcerative colitis.
PNV-6005 DSS-induced ulcerative colitis model (mice)
CHARLOTTESVILLE, WA, September 6, 2022 (GLOBE NEWSWIRE) - Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) ("Adial" or the "Company") today acquired Purnovate, Inc., a subsidiary of Adial. focus on developing novel adenosine receptor-targeted molecules to meet key unmet medical needs and positive data from in vivo studies in mice given PNV-6005 Purnovate as a potential treatment for inflammatory bowel disease.
PNV-6005 is a selective adenosine 2A receptor agonist believed to have anti-inflammatory properties and protective effects against colitis and other inflammatory bowel diseases (IBD). In the study, PNV-6005 showed statistically significant effects on both primary study endpoints, the preclinical endpoints, which are expected to demonstrate potential efficacy against ulcerative colitis in humans. Specifically, PNV-6005 (i) significantly prevented weight loss compared to the control group (preventing more than 50% weight loss) and (ii) significantly reduced colon damage, as evidenced by length reduction of the colon in PNV-6005-colon prevented. treated group (almost complete prevention) and reduction of inflammation according to histological data.
Research by Dr. Peter Ernst, DVM, PhD, Professor of Pathology at the University of California San Diego (UC San Diego), expert in immunology, inflammation and infectious diseases.
The photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1664150a-b1eb-4bc6-874a-e7462f47b19d.
instructive drawing
The study used the DSS-induced colitis model, which is widely used in humans for its simplicity and similarity to ulcerative colitis.
PNV-6005 was administered intraperitoneally at a dose of 6 μg / kg twice daily for 7 days.
DSS was added to drinking water at a concentration of 4%.
The study included four groups of 5 mice each: (i) one group with normal drinking water; (ii) group with 4% v / v DSS concentration in drinking water; and (iii) two treatment groups who received an intra-abdominal injection of PNV6005.
The story continues
The positive results follow a recent collaboration agreement between Purnovate and UC San Diego, a leading university in education and research, to explore specific adenosine analogs as potential treatments for inflammatory diseases, including inflammatory bowel diseases. and infectious diseases with strong immune responses. cytokine storm) plays an important role.
Dr. Ernst said: “We are encouraged by these results, which demonstrate both the in vivo potential and the ability of Purnovate adenosine compounds to effectively address historical solubility and biodistribution problems. We look forward to developing this study on ulcerative colitis as well as the broader indications of IBD and other inflammatory diseases. "
William Stilley, CEO of Purnovate, said, “We are delighted to announce that Drs. Ernst and UC San Diego support this important research and look forward to advancing PNV-6005 in the first human clinical trials. Ulcerative colitis is the most common form of IBD and causes inflammation and ulcers in the digestive tract, affecting approximately 1 million people in the United States alone. According to QY Research Medical, the ulcerative colitis market was valued at $ 6.2 billion in 2020 and is expected to reach $ 10.8 billion by 2030. Our Adenosine Purnovate platform for other inflammatory conditions.
"This additional information builds our confidence in the potential of our Purnovate platform and the many opportunities it offers," said Kerry Claiborne, CEO of Adial. “We will continue to update our progress with Purnovate by moving the first drug candidates from this program to clinical development. Additionally, we see good synergies between Adial and Purnovate's work to bring AD04 to market, with a focus on building our addiction and pain treatment pipeline.
Purnovate, Inc. of
Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, Inc., is a pharmaceutical and chemical company specializing in the discovery and development of selective, potent, stable, and soluble drug candidates that target the adenosine receptor for treatment of diseases and ailments. such as the treatment of inflammatory diseases and disorders such as asthma, cancer, diabetes, pain and healing of burns / wounds, inflammatory bowel diseases and infectious diseases such as non-alcoholic steatohepatitis (NASH). For more information, visit www.adial.com/purnovate/.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical stage biopharmaceutical company developing addiction drugs. The company's new flagship drug, AD04, a genetically targeted serotonin-3 receptor antagonist for the treatment of alcohol consumption disorder (AUD) in heavy drinkers, has recently entered a pivotal Phase clinical trial. 3. The ONWARD ™ study explores the potential of a business partner. A diagnostic genetic test is the treatment of AUD in patients with identified specific target genotypes (estimated to represent approximately one third of the AUD population). Forward showed promise in reducing excessive alcohol consumption in heavy drinkers and there were no apparent safety or tolerability concerns. AD04 is also believed to be able to treat other addictions such as opioid use disorder, gambling and obesity. The company is also developing adenosine analogues for the treatment of pain and other conditions. For more information, visit www.adial.com.
Forward-Looking Statements
This version contains certain "forward-looking statements" under the US federal securities laws. Such statements are based on various facts and are made using many important assumptions and involve known and unknown risks, uncertainties and causes that actual results, performance or results may differ materially from any actual or anticipated future outcome, performance or outcome. factors that can be Avoid such forward-looking statements. The preceding expressions followed by the words "believe", "anticipate", "anticipate", "intend", "anticipate", "estimate", "plan", or otherwise "believe", "anticipate", "expect", consist of . 'and similar future or conditional expressions or verbs such as' will', 'should', 'will', 'might' and 'might' tend to be future-oriented rather than historical facts, although not all are future-oriented. statements include the above. Forward-looking statements include statements about the possible treatment of inflammatory bowel disease with Purnovate PNV-6005, the anti-inflammatory properties of PNV-6005, and its protective effect against colitis and other inflammatory bowel diseases. indications and other inflammatory diseases, PNV-6005 begins the first human clinical trials, the ulcerative colitis market is expected to reach $ 10.8 billion by 2030, the broad potential and diversity of the adenosine Purnovate platform in other inflammatory diseases and the opioid potential of AD04 to treat other addictions such as substance use disorders, gambling and obesity. All forward-looking statements presented here reflect our current views and are subject to certain risks and uncertainties, including but not limited to our ability to further confirm the anti-inflammatory properties of PNV-6005 and its protective potential against colitis and others. inflammatory conditions in the intestines. diseases in humans. clinical studies, our ability to demonstrate the potential of adenosine compounds as alternative or complementary therapies, our ability to complete clinical studies in a timely manner and achieve expected results and benefits, our ability to gain regulatory approval for market candidate products or meet current regulatory requirements, certain regulatory limits our ability to promote or market our candidate products, market acceptance of our candidate products and the successful development, marketing or sale of our products, our ability to maintain our licensing agreements, the continued maintenance and growth of our patent portfolio, our ability to establish and maintain partnerships, our capital requirements for funding and / or our ability to obtain or retain grants for our research activities as well as our capacity to keep our whole key person or support our business. listing on Nasdaq. These risks are not to be considered exhaustive and should be read in conjunction with other cautionary statements contained in our Annual Report on Form 10-K for the year ended December 31, 2021, subsequent quarterly reports on Form 10-Q and current reports. Form 8-K was filed with the Securities and Exchange Commission. Any forward-looking statement is effective only as of the date it was made. Except as required by law, we undertake no obligation to publicly update or revise any forward-looking statements as a result of new information, future events, changed circumstances or otherwise.
Contact: Crescendo Communications, LLC David Waldman / Natalia Rudman Phone: 212-671-1021 Email: adil@crescendo-ir.com
