Nuevolution obtains new data in its internal RORγt program supporting effect in human inflammatory bowel diseases (IBD)
Stockholm, 26 April 2018. Nuevolution AB (publ) (NUE.ST) today announced that the company has obtained additional positive data from a pre-clinical mouse model supporting efficacy of its RORγt candidate within inflammatory bowel diseases* such as Crohn’s disease and Ulcerative colitis.
Nuevolution has previously presented positive preclinical data on its RORγt candidate compound in two chemically induced preclinical models of IBD. In this new mouse study, colon inflammation and ulcerations were induced by adoptive transfer of pro-inflammatory T-cells from a healthy donor to an immune-compromised recipient unable to repress active T-cells, thereby inducing a clinical condition mimicking human IBD.
The Nuevolution RORγt candidate was tested in the challenging therapeutic setting, where treatment is initiated only following body weight loss and disease onset, requiring high compound efficacy to observe clinical improvement. The compound, dosed orally and twice daily at 30 or 100 mpk**, gave a dose proportional improvement of the disease activity index as well as inflammation and ulceration to the colon. The clinical improvements observed using the RORγt inhibitor at the highest dose, were either on par with, or superior to alternative treatment arms using either steroid or a neutralizing antibody targeting IL17A.
These positive data, obtained from the benchmark preclinical model of IBD, are well in line with previous data from the chemical IBD models and provide additional support the efficacy of the RORγt candidate compound and its potential future clinical application within IBD. The data will be further explained in the upcoming quarterly report being published May 8th, 2018.
“We are obviously delighted to see this positive outcome from the testing of our RORγt candidate compound, especially considering the high demands for compound efficacy when running the model in the more challenging therapeutic setting” said Thomas Franch, CSO and continued “collectively, all the data we have points to IBD as having both an obvious and possibly promising clinical route forward”.
As previously communicated, Nuevolution has recommended the arthritis type of disease termed Ankylosing spondylitis as the preferred initial clinical lead indication for its RORγt program based on an expected overall lower risk in the clinical development. However, the new data provide further support for IBD as a potential next in line secondary indication for a future development.
Further to these IBD data, the company has also completed the kilo-gram scale synthesis (API) of its RORγt clinical candidate preparing any potential further process of entering animal regulatory safety studies.
* Inflammatory bowel disease is a group of chronic inflammatory conditions impacting the gastrointestinal tract. Crohn’s disease and Ulcerative colitis are among the most prevalent inflammatory bowel diseases, impacting approximately 3 million people in the United States, Europe and Japan
**mpk = milligram test compound per kilogram body weight
For more information, please contact:
Johnny Stilou, Director of investor relations
phone: +45 8877 5973
Thomas Franch, CSO
Phone: +45 7020 0987
The Nuevolution Chemetics™ platform technology comprises proprietary methods enabling DNA-encoding of compound libraries for fast and cost-efficient screening of disease targets. Nuevolution annually produces up to eight Chemetics™ libraries. For further details see Nuevolution homepage: www.nuevolution.com.
Nuevolution AB (publ) is a leading small molecule drug discovery biotech company founded in 2001, headquartered in Copenhagen, Denmark. Nuevolution partners its proprietary discovery platform and programs with pharmaceutical and biotechnology companies to seek future benefit for patients in need of novel medical treatment options. Nuevolution’s internal programs are focused on therapeutically important targets within inflammation, oncology and immuno-oncology.
This information is information that Nuevolution AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact persons set out above, on Thursday 26 April 2018, 14:30 CET.
Nuevolution AB (publ) is listed at Nasdaq First North Premier in Stockholm, Sweden (ticker: NUE.ST). Redeye AB acts as Certified Adviser to Nuevolution AB (publ). More information about Nuevolution can be found at: www.nuevolution.com.