NEW YORK, NY, USA I August 20, 2020 I Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-856, an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and 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 clearance from the Bellberry Human Research Ethics Committee in Australia to begin a phase 1 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 (IBS-D), ulcerative colitis (UC) and Crohn’s disease (CD).
“Dosing of the first healthy volunteer in our phase 1 clinical program of IMU-856 brings us one step closer to evaluating whether our approach may eventually translate into a novel treatment option for patients suffering from a range of gastrointestinal diseases, by potentially restoring function of the intestinal barrier without impairing the immune system,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Based on strong preclinical data, IMU-856 shows significant therapeutic potential for diseases that are known to be triggered by the disruption of intestinal barrier function.”
The phase 1 study is a double-blind, randomized, placebo-controlled trial comprised of three parts. The first part is a single ascending dose portion in healthy volunteers, which is planned to be followed by a second, multiple ascending dose part in healthy volunteers, with IMU-856 given daily for 14 consecutive days. These first two parts of the phase 1 trial are designed to assess the safety, tolerability and pharmacokinetic properties of IMU-856. In a third part of the phase 1 trial, the study drug would be given daily over 28 consecutive days at two different dose levels in patients with IBS-D, UC and CD who were screened for increased bowel permeability using oral marker tests. The change in bowel permeability, using a 2-sugar test to monitor therapeutic effects, would be evaluated as a pharmacodynamic marker, and include a comparison of two active dose groups to placebo. Additionally, biomarker, safety and trough plasma concentration levels would also be assessed.
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.”
IMU-856 was discovered and initially developed by Daiichi Sankyo Co., Ltd. (Daiichi Sankyo). In November 2018, Immunic and Daiichi Sankyo entered into a global option and license agreement, granting Immunic an exclusive global option to obtain the exclusive right to license a group of compounds, designated by Immunic as IMU-856. Under this agreement, Immunic has the rights to commercialization of IMU-856 in all countries, including the United States, Europe and Japan. The option also includes exclusivity on a patent application filed by Daiichi Sankyo, covering IMU-856’s composition of matter. Immunic exercised the option in January 2020.
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.
SOURCE: Immunic
Post Views: 312
NEW YORK, NY, USA I August 20, 2020 I Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies aimed at treating chronic inflammatory and autoimmune diseases, today announced dosing of the first healthy volunteer in the company’s phase 1 clinical program of IMU-856, an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of intestinal barrier function. Based on preclinical data, the compound appears to represent a novel and 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 clearance from the Bellberry Human Research Ethics Committee in Australia to begin a phase 1 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 (IBS-D), ulcerative colitis (UC) and Crohn’s disease (CD).
“Dosing of the first healthy volunteer in our phase 1 clinical program of IMU-856 brings us one step closer to evaluating whether our approach may eventually translate into a novel treatment option for patients suffering from a range of gastrointestinal diseases, by potentially restoring function of the intestinal barrier without impairing the immune system,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Based on strong preclinical data, IMU-856 shows significant therapeutic potential for diseases that are known to be triggered by the disruption of intestinal barrier function.”
The phase 1 study is a double-blind, randomized, placebo-controlled trial comprised of three parts. The first part is a single ascending dose portion in healthy volunteers, which is planned to be followed by a second, multiple ascending dose part in healthy volunteers, with IMU-856 given daily for 14 consecutive days. These first two parts of the phase 1 trial are designed to assess the safety, tolerability and pharmacokinetic properties of IMU-856. In a third part of the phase 1 trial, the study drug would be given daily over 28 consecutive days at two different dose levels in patients with IBS-D, UC and CD who were screened for increased bowel permeability using oral marker tests. The change in bowel permeability, using a 2-sugar test to monitor therapeutic effects, would be evaluated as a pharmacodynamic marker, and include a comparison of two active dose groups to placebo. Additionally, biomarker, safety and trough plasma concentration levels would also be assessed.
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.”
IMU-856 was discovered and initially developed by Daiichi Sankyo Co., Ltd. (Daiichi Sankyo). In November 2018, Immunic and Daiichi Sankyo entered into a global option and license agreement, granting Immunic an exclusive global option to obtain the exclusive right to license a group of compounds, designated by Immunic as IMU-856. Under this agreement, Immunic has the rights to commercialization of IMU-856 in all countries, including the United States, Europe and Japan. The option also includes exclusivity on a patent application filed by Daiichi Sankyo, covering IMU-856’s composition of matter. Immunic exercised the option in January 2020.
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.
SOURCE: Immunic
Post Views: 312