Nuevolution has developed potent and selective compounds, with a benign safety profile targeting the first bromodomain of the BET family of proteins and recently nominated NUE20798 as its development candidate.

The present model and our collective data validate a potent effect of NUE20798 on the CCL2 chemokine biomarker relevant across atopic dermatitis, fibrotic diseases including potentially cancer fibrosis.

"We think the outcomes of this study is very encouraging, since we see efficacy of NUE20798 in an atopic dermatitis model, supported by potent CCL2 inhibition, while our compound shows no evidence of having a negative impact on blood platelets levels", commented Thomas Franch, CSO at Nuevolution.

Based on multiple positive program data in mouse efficacy models without the observation of the typical adverse toxicity seen with non-selective BET inhibition, Nuevolution continues its program progression towards readiness for human clinical testing within fibrosis diseases and atopic dermatitis.

As a next step, NUE20798 has now entered first stage of compound material upscaling with the intent to commence regulatory safety studies prior to future human clinical testing.

Further detailed information

Previous data support a potent suppression by NUE20798 of the CCL2 chemokine production from stimulated human skin cells (keratinocytes) mimicking aspects of atopic dermatitis. Based on the positive in vitro data on keratinocytes, Nuevolution conducted this in vivo testing of NUE20798 for effect in the Calcipotriol-induced atopic dermatitis mouse model. Following 11 days of oral dosing with NUE20798, reduction of disease level and potent suppression of the CCL2 disease biomarker was observed for all three dosing arms [3, 10 and 30 mg/kg, twice daily]. Further safety evaluation in the study based on blood platelet count, a well-established safety liability for non-selective BET inhibitors, showed no adverse effect on platelet numbers even at the highest dose of NUE20798.

More than 13 million (diagnosed) patients world-wide suffer from atopic dermatitis and the market is forecasted to grow to USD 9.5 billion in 2020. The market opportunity in the treatment of fibrotic diseases, like idiopathic pulmonary fibrosis (IPF) as well as scleroderma (SSc), is also highly attractive. The IPF market is expected to grow with approximately 7,5% to USD 3.5 bn. in 2024, whereas a market growth of approximately 5% is expected in SSc.

For more information, please contact:

Thomas Franch, CSO

Phone: +4539130922

Email: tf@nuevolution.com

Johnny Stilou, CFO

Phone: +45 8877 5973

Email: jost@nuevolution.com 

Information about Nuevolution AB (publ)

Nuevolution AB (publ) is a leading small molecule drug discovery biotech company founded in 2001, and headquartered in Copenhagen, Denmark. Nuevolution partners its discovery platform and develops its programs alone and in collaboration 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 diseases targets within severe inflammatory diseases and cancer.

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 9 May 2019 at 08.00 AM CET.

Nuevolution AB (publ) is listed at Nasdaq in Stockholm, Sweden (ticker: NUE). More information about Nuevolution can be found on: www.nuevolution.com