News: Avance Clinical Client Immunic, Inc. Announced Dosing of First Healthy Volunteer in Phase 1 Clinical Program of IMU-856, Targeting Restoration of Intestinal Barrier Function
September 4, 2020
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 program of IMU-856, an novel treatment for patients suffering from gastrointestinal diseases, including diarrhea-predominant irritable bowel syndrome, ulcerative colitis and Crohn’s disease.
Adelaide, Australia – 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 program of IMU-856, an novel treatment for patients
suffering from gastrointestinal diseases, including diarrhea-predominant irritable
bowel syndrome, ulcerative colitis and Crohn’s disease.
Immunic Therapeutics (Nasdaq: IMUX) isa 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 program includes single and multiple
ascending dose parts in healthy volunteers. Subsequently, Immunic also plans to
extend this program to assess biomarker, safety and drug trough levels in
patients with diarrhea-predominant irritable bowel syndrome, ulcerative colitis
and Crohn’s disease.
Hella Kohlhof, Ph.D., 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 normalize 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
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company with
a pipeline of selective oral immunology therapies aimed at treating chronic
inflammatory and autoimmune diseases, including relapsing-remitting multiple
sclerosis, ulcerative colitis, Crohn’s disease, and psoriasis. Immunic is
developing three small molecule products: its lead development program,
IMU-838, is a selective immune modulator that inhibits the intracellular
metabolism of activated immune cells by blocking the enzyme DHODH and exhibits
a host-based antiviral effect; IMU-935 is an inverse agonist of RORγt; and
IMU-856 targets the restoration of the intestinal barrier function. On August
2, 2020, Immunic announced positive top-line results from its phase 2 EMPhASIS
trial of IMU-838 in patients with relapsing-remitting multiple sclerosis,
reporting achievement of both primary and key secondary endpoints with high
statistical significance, indicating activity for IMU-838 in this indication.
IMU-838 is also in phase 2 clinical development for ulcerative colitis and
COVID-19, with an additional phase 2 trial considered in Crohn’s disease. An
investigator-sponsored proof-of-concept clinical trial for IMU-838 in primary
sclerosing cholangitis is ongoing at the Mayo Clinic. For further information,
please visit: www.imux.com.
About Avance Clinical
Australia’s Avance Clinical has more than 20-years of experience and is now one
of Australia’s leading Contract Research Organizations. Avance Clinical
facilitates quality drug development by aligning people, skills, and expertise
in the pursuit of drug development for a healthier world.
Avance Clinical is committed to providing high-quality clinical research
services with its highly-experienced team.
The collective pool of knowledge and experience at Avance Clinical continually
grows through the careful selection of experts who also demonstrate passion in
their chosen field.
Avance Clinical offers high-quality services in an established clinical trial
ecosystem, that includes world-class Investigators and Sites able to access
specialized patient groups. Visit http://www.avancecro.com for more information.
Other benefits include:
1. The Government R&D grant means up to 43.5% rebate on clinical trial
2. Telehealth pivot during COVID-19 pandemic – speed and continuity
3. Site Initiation Visit (SIV) and Study Start achieved in 5 – 6 weeks
4. No IND required for clinical trials
5. Full GMP material is not mandated for Phase I clinical trials
6. Established clinical trial environment with world-class Investigators and
7. Established healthy subject databases and specialized patient populations
8. Five independent Phase 1 facilities across Australia including
hospital-based units for critical care
9. Major hospitals with world-class infrastructures and dedicated Clinical
Trial Units with a long track-record in FDA compliant research
10. Seasonal studies: Northern hemisphere Sponsors can conduct their studies year-round
by taking advantage of Australia’s counter-flu and allergy seasons