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  1. Avance Clinical
7 September 2020

Dosing of First Healthy Volunteer in Phase 1 Clinical Programme of IMU-856

The leading Australian CRO for biotechs and Frost & Sullivan 2020 Asia-Pacific CRO Market Leadership Award winner Avance Clinical is pleased to share the news that its client Immunic Therapeutics has announced dosing of the first healthy volunteer in the company’s phase 1 clinical programme of IMU-856, a novel treatment for patients suffering from gastrointestinal diseases, including diarrhoea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease.

Immunic Therapeutics (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases.

According to the public announcement released by Immunic Therapeutics on 20 August 2020:

  • IMU-856, an orally available, small molecule modulator, serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and potentially paradigm-shifting approach to the treatment of gastrointestinal diseases by potentially restoring intestinal barrier function while maintaining immunocompetency.
  • Immunic’s Australian subsidiary, Immunic Australia Pty Ltd., received approval from the Bellberry Human Research Ethics Committee in Australia to conduct a phase 1 clinical trial of IMU-856 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 clinical programme includes single and multiple ascending dose parts in healthy volunteers. Subsequently, Immunic also plans to extend this programme to assess biomarker, safety and drug trough levels in patients with diarrhoea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease.

Hella Kohlhof, PhD, Chief Scientific Officer of Immunic, noted, “Current treatments for many gastrointestinal conditions focus on inhibiting inflammation and do not directly address impaired intestinal barrier function. In contrast, IMU-856 appears to have a unique targeted ability to strengthen and thereby normalise this function, potentially avoiding the bacterial triggers which can occur when the intestinal barrier is impaired. Moreover, because this approach appears to avoid any detrimental effects on the immune system, we believe that IMU-856 has the potential to change the treatment paradigm for gastrointestinal diseases.”

Avance Clinical Chief Scientific Officer Gabriel Kremmidiotis PhD, BSC Hon said “We consider ourselves fortunate to be working with Immunic on this exciting project. IMU-856 is the second compound that Immunic has selected Avance Clinical as their CRO. Our engagement in these projects has been from early planning, study design, preparation of the investigator brochures and clinical trial protocols. Working with the Immunic team and the Bellberry Human Research Ethics Committee, we have been able to design clinical trials which include careful data-informed adaptive elements aimed at expediting the transition of these promising products from healthy volunteers to the patient populations.”

For the full announcement or additional information on Avance Clinical or its client Immunic Therapeutics, please fill out the enquiry form attached to this page.

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