GlobeNewswire by notified

Saniona selects highly promising preclinical candidate with broad potential in autoimmune disorders

Share

PRESS RELEASE

July 22, 2019                                                            

  • Preclinical candidate SAN903 to be developed to Phase 1 clinical study in 18 months
  • First-in-class compound with a new mode-of-action and strong IP

Saniona AB (OMX: SANION) today announces that it has selected a new development candidate, SAN903, for preclinical development, which can enter clinical Phase 1 in only 18 months. Based on work done to date, Saniona has elected to focus SAN903 initially on the treatment of Crohn’s disease and colitis.

“SAN903, which is generated from our advanced ion channel platform, is a first-in-class product and, we believe, has the potential to transform the treatment paradigm for severe autoimmune diseases, including Crohn’s disease and colitis. We look forward to bringing this exciting asset to the stage of Phase 1 first-in-man clinical studies in early 2021,” said Jørgen Drejer, CEO of Saniona.

With SAN903, Saniona has identified a novel proprietary IK channel inhibitor that effectively dampens gut inflammation and can be used for the treatment of inflammatory bowel diseases (IBD), like Crohn`s disease and ulcerative colitis. The drug will likely be the first ion channel modulator for IBD.

The IK potassium channel is very important for controlling immune cell functions in both peripheral tissues and the brain. A precise pharmacological modulation of the IK channel can thus be used for treatment of multiple diseases which involve overactive or mistimed immunological reactions, such as autoimmune diseases like rheumatic arthritis and multiple sclerosis, the prevention of organ rejection after transplantation, and reducing brain damage after a stroke. Furthermore, SAN903 also has potential in certain rare blood diseases, where Saniona may obtain an orphan designation, and develop the product all the way to the market.

The preclinical development of SAN903 will encompass scale-up of the manufacturing process, GMP production and various toxicology studies, which will form the basis for a regulatory application to initiate first-in-man clinical trials. Saniona is concurrently working with its development partners to initiate Phase 1 clinical trials early 2021.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@saniona.com

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on July 22, 2019.

About Saniona

Saniona is a research and development company focused on drugs for diseases of the central nervous system and eating disorders. The company has five programs in clinical development. Saniona intends to develop and commercialize treatments for orphan indications such as Prader-Willi syndrome and hypothalamic obesity on its own. The research is focused on ion channels and the company has a broad portfolio of research programs. Saniona has partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and the company’s shares are listed at Nasdaq Stockholm Small Cap (OMX: SANION). Read more at www.saniona.com.

About SAN903

SAN903 inhibits the IK potassium channel (also known as KCa3.1, encoded by the gene KCNN4), which is important for controlling immune cell functions. A precise pharmacological modulation of the IK channel can thus treat diseases, which involve overactive or mistimed immune reactions, such as inflammatory bowel diseases and potentially also rheumatic arthritis and multiple sclerosis. Saniona assesses that SAN903 is the first ion channel modulator developed for IBD and will thus become first-in-class. SAN903 may also have potential to treat a rare congenital blood disease called hereditary xerocytosis (HX), which is caused by mutations in the IK channel.  SAN903 has excellent freedom-to-operate and composition-of-matter protection until 2039.

About Inflammatory Bowel Diseases, IBD

Inflammatory bowel disease (IBD) is a group of inflammatory conditions in the large - and small intestine. It is estimated that more than 3.5 million patients are diagnosed with IBD (colitis and Crohn’s patients) in Europe and the U.S.1 The prevalence and incidence of IBD is increasing worldwide, especially in countries with an established or newly adopted Western lifestyle.

The market for anti-inflammatory treatments in IBD is estimated to be more than USD 5.9 billion in 20142. IBD patients require maintenance treatment as well as frequent interventions with strongly immune suppressing medicines, which have numerous side-effects. Currently used anti-IBD drugs are anti-inflammatory (5-ASA´s, steroids), generally immune dampening (azathioprine, 6-mercaptopurine), or biologics targeting specific cytokines/integrins (e.g. infliximab, ustekinomab, vedolizumab) as well as JAK inhibitors (e.g. tofacitinib). Despite the medication IBD patients often face a gradual worsening of their condition due to chronic fibrotic changes in the gut, which may lead to life-threatening obstructions that must be resolved by acute gut-shortening surgery. There is preclinical evidence that the SAN903 mechanism may both reduce ongoing intestinal inflammation and have an independent effect on the chronic complications of the disease without  side effects observed with the traditional IBD medicines.




1 www.ncbi.nlm.nih.gov/pubmed/26323879.

2 Major markets 2014, Datamonitor


Attachment

To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire by notified

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire by notified

Subscribe to all the latest releases from GlobeNewswire by notified by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire by notified

Iveco Group signs a 150 million euro term loan facility with Cassa Depositi e Prestiti to support investments in research, development and innovation11.6.2024 12:00:00 CEST | Press release

Turin, 11th June 2024. Iveco Group N.V. (EXM: IVG), a global automotive leader active in the Commercial & Specialty Vehicles, Powertrain and related Financial Services arenas, has successfully signed a term loan facility of 150 million euros with Cassa Depositi e Prestiti (CDP), for the creation of new projects in Italy dedicated to research, development and innovation. In detail, through the resources made available by CDP, Iveco Group will develop innovative technologies and architectures in the field of electric propulsion and further develop solutions for autonomous driving, digitalisation and vehicle connectivity aimed at increasing efficiency, safety, driving comfort and productivity. The financed investments, which will have a 5-year amortising profile, will be made by Iveco Group in Italy by the end of 2025. Iveco Group N.V. (EXM: IVG) is the home of unique people and brands that power your business and mission to advance a more sustainable society. The eight brands are each a

DSV, 1115 - SHARE BUYBACK IN DSV A/S11.6.2024 11:22:17 CEST | Press release

Company Announcement No. 1115 On 24 April 2024, we initiated a share buyback programme, as described in Company Announcement No. 1104. According to the programme, the company will in the period from 24 April 2024 until 23 July 2024 purchase own shares up to a maximum value of DKK 1,000 million, and no more than 1,700,000 shares, corresponding to 0.79% of the share capital at commencement of the programme. The programme has been implemented in accordance with Regulation No. 596/2014 of the European Parliament and Council of 16 April 2014 (“MAR”) (save for the rules on share buyback programmes set out in MAR article 5) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the Safe Harbour rules. Trading dayNumber of shares bought backAverage transaction priceAmount DKKAccumulated trading for days 1-25478,1001,023.01489,100,86026:3 June 20247,0001,050.597,354,13027:4 June 20245,0001,055.705,278,50028:6 June20243,0001,096.273,288,81029:7 June 20244,0001,106.174,424,68

Landsbankinn hf.: Offering of covered bonds11.6.2024 11:16:36 CEST | Press release

Landsbankinn will offer covered bonds for sale via auction held on Thursday 13 June at 15:00. An inflation-linked series, LBANK CBI 30, will be offered for sale. In connection with the auction, a covered bond exchange offering will take place, where holders of the inflation-linked series LBANK CBI 24 can sell the covered bonds in the series against covered bonds bought in the above-mentioned auction. The clean price of the bonds is predefined at 99,594. Expected settlement date is 20 June 2024. Covered bonds issued by Landsbankinn are rated A+ with stable outlook by S&P Global Ratings. Landsbankinn Capital Markets will manage the auction. For further information, please call +354 410 7330 or email verdbrefamidlun@landsbankinn.is.

Relay42 unlocks customer intelligence with a new insights and reporting module, powered by Amazon QuickSight11.6.2024 11:00:00 CEST | Press release

AMSTERDAM, June 11, 2024 (GLOBE NEWSWIRE) -- Relay42, a leading European Customer Data Platform (CDP), is leveraging Amazon QuickSight to power its new real-time customer intelligence, reporting, and dashboard module. Harnessing the breadth and quality of customer data, the new Insights module empowers marketing teams to dive deep into customer behaviors and gain invaluable insights into the performance of their marketing programs across all online, offline, paid, and owned marketing channels. Preview of the Relay42 Insights module, in pre-beta version Key capabilities of the Relay42 Insights module include: Deep insights into customer behaviors: With the Relay42 Insights module, marketers can ask unlimited questions about their data and gain a deeper understanding of how to serve their customers more effectively. Simplicity with AI-powered querying: Marketers can use artificial intelligence to query their data using natural language search, reducing the reliance on data scientists. Us

Metasphere Labs Announces X Spaces Event on the Topic of Green Bitcoin Mining and Sound Money for Sustainability11.6.2024 10:30:00 CEST | Press release

VANCOUVER, British Columbia, June 11, 2024 (GLOBE NEWSWIRE) -- Metasphere Labs Inc. (formerly Looking Glass Labs Ltd., "Metasphere Labs" or the "Company") (Cboe Canada: LABZ) (OTC: LABZF) (FRA: H1N) is thrilled to announce an engaging Twitter Spaces event on Green Bitcoin mining, energy markets, and sustainability on July 3, 2024 at 2 p.m. ET. Follow us on X at MetasphereLabs for updates and to join the event. What We'll Discuss Bitcoin Mining Basics: Understand the fundamentals of Bitcoin mining.Energy Market Dynamics: Explore how Bitcoin mining interacts with energy markets.Sustainable Innovations: Learn about our efforts to promote sustainability in Bitcoin mining.Sound Money: Discover how tamper-proof currency can enhance stability.Efficient Payment Rails: See how fast, neutral payment systems support humanitarian projects.Carbon Footprint: Compare Bitcoin's environmental impact with traditional banking. "We're excited to host this event and dive into the critical topics of Bitcoin

World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye