SAN DIEGO, CA, USA I September 18, 2019 I Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt, believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. Immunic’s Australian subsidiary, Immunic Australia Pty Ltd., received clearance from the Bellberry Human Research Ethics Committee in Australia to begin phase 1 trials of IMU-935 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 program includes single and multiple ascending dose trials in healthy volunteers. Immunic also plans to extend these studies to assess safety and mechanism-related biomarkers in patients with psoriasis.
The first phase 1 trial is a single ascending dose, double-blind, placebo-controlled study of IMU-935 in healthy volunteers. The trial is designed to evaluate the drug’s safety and pharmacokinetic profile and will also include the evaluation of food effects.
“The dosing of the first healthy volunteer in our phase 1 program of IMU-935 represents an important inflection point for Immunic, as we progress, on plan, with the development of this important pipeline candidate,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “RORγt is a target that has generated a high degree of interest within the pharmaceutical and biotechnology communities, given its potential to restore the balance between pro-inflammatory and regulatory lymphocytes and modulate a range of cytokines involved in various immune-mediated diseases. The strength of our own preclinical data leads us to believe that IMU-935 has best-in-class potential as an oral therapy for a number of inflammatory and autoimmune diseases.”
Following the phase 1 single ascending dose trial, Immunic plans to initiate a second phase 1 trial which will be a multiple ascending dose, double-blind, placebo-controlled study in healthy volunteers with IMU-935 given daily for 14 consecutive days. This study will assess the safety, pharmacodynamic and pharmacokinetic properties of IMU-935. The company expects to extend these multiple ascending dose studies in the first half of 2020 by including mild-to-moderate psoriasis patients given IMU-935 daily over 28 consecutive days, in order to assess safety and mechanism-related biomarkers in patients with psoriasis.
Andreas Muehler, M.D., Chief Medical Officer of Immunic, noted, “We look forward to expanding the study to psoriasis patients next year, as we believe that psoriasis provides a prototype disease where the safety and biomarkers related to the mechanism of action of IMU-935 can be evaluated within the dosing limitations of an early clinical trial. Importantly, this may help to guide the planning of a phase 2 program and we expect that it will provide us with preliminary insights regarding the optimal dosing range which may be safe and active.”
About IMU-935
IMU-935 is a highly potent and selective inverse agonist of RORγt (retinoic acid receptor-related orphan nuclear receptor gamma) with additional activity on DHODH (dihydroorotate dehydrogenase). The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong cytokine inhibition targeting both Th17 and Th1 responses in preclinical testing, as well as indications of activity in animal models for psoriasis and inflammatory bowel disease. Preclinical experiments indicate that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing 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. The company is developing three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets the restoration of the intestinal barrier function. Immunic’s lead development program, IMU-838, is in phase 2 clinical development for relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial planned 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.immunic-therapeutics.com.
SOURCE: Immunic
Post Views: 105
SAN DIEGO, CA, USA I September 18, 2019 I Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing potentially best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt, believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. Immunic’s Australian subsidiary, Immunic Australia Pty Ltd., received clearance from the Bellberry Human Research Ethics Committee in Australia to begin phase 1 trials of IMU-935 under the Clinical Trial Notification (CTN) scheme of the Australian Therapeutic Goods Administration (TGA). The phase 1 program includes single and multiple ascending dose trials in healthy volunteers. Immunic also plans to extend these studies to assess safety and mechanism-related biomarkers in patients with psoriasis.
The first phase 1 trial is a single ascending dose, double-blind, placebo-controlled study of IMU-935 in healthy volunteers. The trial is designed to evaluate the drug’s safety and pharmacokinetic profile and will also include the evaluation of food effects.
“The dosing of the first healthy volunteer in our phase 1 program of IMU-935 represents an important inflection point for Immunic, as we progress, on plan, with the development of this important pipeline candidate,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “RORγt is a target that has generated a high degree of interest within the pharmaceutical and biotechnology communities, given its potential to restore the balance between pro-inflammatory and regulatory lymphocytes and modulate a range of cytokines involved in various immune-mediated diseases. The strength of our own preclinical data leads us to believe that IMU-935 has best-in-class potential as an oral therapy for a number of inflammatory and autoimmune diseases.”
Following the phase 1 single ascending dose trial, Immunic plans to initiate a second phase 1 trial which will be a multiple ascending dose, double-blind, placebo-controlled study in healthy volunteers with IMU-935 given daily for 14 consecutive days. This study will assess the safety, pharmacodynamic and pharmacokinetic properties of IMU-935. The company expects to extend these multiple ascending dose studies in the first half of 2020 by including mild-to-moderate psoriasis patients given IMU-935 daily over 28 consecutive days, in order to assess safety and mechanism-related biomarkers in patients with psoriasis.
Andreas Muehler, M.D., Chief Medical Officer of Immunic, noted, “We look forward to expanding the study to psoriasis patients next year, as we believe that psoriasis provides a prototype disease where the safety and biomarkers related to the mechanism of action of IMU-935 can be evaluated within the dosing limitations of an early clinical trial. Importantly, this may help to guide the planning of a phase 2 program and we expect that it will provide us with preliminary insights regarding the optimal dosing range which may be safe and active.”
About IMU-935
IMU-935 is a highly potent and selective inverse agonist of RORγt (retinoic acid receptor-related orphan nuclear receptor gamma) with additional activity on DHODH (dihydroorotate dehydrogenase). The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong cytokine inhibition targeting both Th17 and Th1 responses in preclinical testing, as well as indications of activity in animal models for psoriasis and inflammatory bowel disease. Preclinical experiments indicate that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation.
About Immunic, Inc.
Immunic, Inc. (Nasdaq: IMUX) is a clinical-stage biopharmaceutical company developing 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. The company is developing three small molecule products: IMU-838 is a selective immune modulator that inhibits the intracellular metabolism of activated immune cells by blocking the enzyme DHODH; IMU-935 is an inverse agonist of RORγt; and IMU-856 targets the restoration of the intestinal barrier function. Immunic’s lead development program, IMU-838, is in phase 2 clinical development for relapsing-remitting multiple sclerosis and ulcerative colitis, with an additional phase 2 trial planned 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.immunic-therapeutics.com.
SOURCE: Immunic
Post Views: 105
