Phase 1 Clinical Studies to begin in First Half of 2020
NEW YORK, NY, USA I January 8, 2020 I Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced that its subsidiary, Immunic AG, under the terms of its existing option and license agreement with Daiichi Sankyo Co., Ltd. (hereinafter, Daiichi Sankyo), has exercised its exclusive global option to license a group of compounds, designated by Immunic as IMU-856. The company intends to begin phase 1 clinical studies for this program in the first half of 2020. IMU-856 is an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of the intestinal barrier function. As such, IMU-856 represents a new and potentially disruptive approach for the treatment of intestinal diseases with the potential to restore the intestinal barrier function while maintaining immunocompetency.
IMU-856 was discovered and developed by Daiichi Sankyo. The option and license agreement gives Immunic the exclusive 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. Concurrent with the option exercise, Immunic will pay to Daiichi Sankyo a one-time upfront licensing fee. Going forward, Daiichi Sankyo is eligible to receive certain future development, approval and sales milestone payments, as well as royalties related to IMU-856. Financial terms of the agreement have not been disclosed.
“Exercising this option is an important milestone, as it indicates that we are convinced of the preclinical safety profile of IMU-856 and are ready to take this program into phase 1 clinical trials, which we intend to initiate during the first half of 2020,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Our recently presented preclinical data reinforced our belief that IMU-856 has disease-modifying properties for a variety of intestinal diseases and demonstrates potential significant advantages over current immunosuppressive treatments which address inflammation while unintentionally decreasing the body’s immune surveillance. We are hopeful that the planned phase 1, single and multiple ascending dose studies will serve as a further important step in the development of IMU-856 as a safe treatment option for patients suffering from gastrointestinal diseases by restoring function to the intestinal barrier without impairing the immune system.”
“We are delighted that Immunic executed the option right for IMU-856,” said Junichi Koga, Senior Executive Officer and Global Head of R&D, Daiichi Sankyo. “Daiichi Sankyo is committed to delivering innovative medicines to patients across the world as quickly as possible, either by ourselves or through strategic partnerships. We are confident that Immunic is our best partner and will rapidly drive the development of this novel compound for patients with intestinal diseases.”
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: 16
Phase 1 Clinical Studies to begin in First Half of 2020
NEW YORK, NY, USA I January 8, 2020 I Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company focused on developing best-in-class, oral therapies for the treatment of chronic inflammatory and autoimmune diseases, today announced that its subsidiary, Immunic AG, under the terms of its existing option and license agreement with Daiichi Sankyo Co., Ltd. (hereinafter, Daiichi Sankyo), has exercised its exclusive global option to license a group of compounds, designated by Immunic as IMU-856. The company intends to begin phase 1 clinical studies for this program in the first half of 2020. IMU-856 is an orally available, small molecule modulator that targets a yet undisclosed protein which serves as a transcriptional regulator of the intestinal barrier function. As such, IMU-856 represents a new and potentially disruptive approach for the treatment of intestinal diseases with the potential to restore the intestinal barrier function while maintaining immunocompetency.
IMU-856 was discovered and developed by Daiichi Sankyo. The option and license agreement gives Immunic the exclusive 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. Concurrent with the option exercise, Immunic will pay to Daiichi Sankyo a one-time upfront licensing fee. Going forward, Daiichi Sankyo is eligible to receive certain future development, approval and sales milestone payments, as well as royalties related to IMU-856. Financial terms of the agreement have not been disclosed.
“Exercising this option is an important milestone, as it indicates that we are convinced of the preclinical safety profile of IMU-856 and are ready to take this program into phase 1 clinical trials, which we intend to initiate during the first half of 2020,” stated Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. “Our recently presented preclinical data reinforced our belief that IMU-856 has disease-modifying properties for a variety of intestinal diseases and demonstrates potential significant advantages over current immunosuppressive treatments which address inflammation while unintentionally decreasing the body’s immune surveillance. We are hopeful that the planned phase 1, single and multiple ascending dose studies will serve as a further important step in the development of IMU-856 as a safe treatment option for patients suffering from gastrointestinal diseases by restoring function to the intestinal barrier without impairing the immune system.”
“We are delighted that Immunic executed the option right for IMU-856,” said Junichi Koga, Senior Executive Officer and Global Head of R&D, Daiichi Sankyo. “Daiichi Sankyo is committed to delivering innovative medicines to patients across the world as quickly as possible, either by ourselves or through strategic partnerships. We are confident that Immunic is our best partner and will rapidly drive the development of this novel compound for patients with intestinal diseases.”
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: 16
