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izokibep: FDA approved Phase II clinical IND application for ankylosing spondylitis
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izokibep: FDA approved Phase II clinical IND application for ankylosing spondylitis.
On February 9, Inmagene Biopharmaceuticals (hereinafter referred to as “Inmagene”), a leading biotechnology company focusing on immune-related diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved its drug candidate izokibep (IMG- 020) Phase II clinical trial IND application for the treatment of ankylosing spondylitis.
Izokibep is jointly developed by Inmagene and its partner Sweden Affibody AB (hereinafter referred to as “Affibody”).
The two parties have reached a strategic cooperation agreement to jointly carry out multi-center clinical trials for five autoimmune diseases worldwide. Inmagene will lead the global clinical trials of axial spondylarthritis, and ankylosing spondylitis is a type of axial spondylarthritis.
It only took more than 8 months forInmagene to sign with Affibody to introduce izokibep to obtain the first IND from FDA. Inmagene plans to obtain 5-8 INDs in 2021 in different regions and for different indications.
“The US FDA’s approval of the Phase II clinical trial for ankylosing spondylitis is an important milestone for the izokibep project.”
r. Jean-Louis Saillot, Chief Development Officer of Inmagene said: “The Inmagene team is very pleased to work closely with Affibody to develop an It may be the best-in-class treatment to improve the condition and quality of life of patients with ankylosing spondylitis worldwide.”
About Inmagene Bio
Inmagene is a leading biotechnology company in the field of immune-related innovative drugs, with wholly-owned subsidiaries in San Diego, Shanghai and Hangzhou, USA.
The Inmagene team upholds the concept of “medicine without borders” and is committed to integrating high-efficiency pharmaceutical resources around the world to develop drug candidates with the first or best potential of its kind for patients around the world.
Inmagene also introduces products for the Asian market from Europe and the United States, and works with partners to conduct global development including global multi-center clinical trials.
Inmagene is building a strong product pipeline that includes more than ten drug candidates. Among them, the most mature drug candidate izokibep is about to enter the global phase II or III clinical trials for multiple indications.
In addition, Inmagene has established strategic partnerships with Hutchison Pharmaceuticals (Nasdaq/London Stock Exchange: HCM) and Affibody to develop and commercialize innovative drugs for immune diseases.
Affibody is a biotechnology company based in Sweden and a holding subsidiary of Patricia Industries.
Affibody has a number of innovative bispecific and multispecific macromolecular drug candidates, and has established two original technology platforms with global intellectual property rights – Affibody® and Albamod™ technology platforms.
Affibody successfully brought two projects into the clinic, one of which is izokibep, and the second is an imaging diagnosis project related to metastatic breast cancer.
Izokibep (also known as IMG-020 or ABY-035) is a bispecific fusion protein candidate drug with a high affinity for interleukin-17A (IL-17A) and serum albumin.
It is developed through two original technologies by Affibody Platform – developed by Affibody® technology and Albamod™ technology.
The former reduces the molecular weight (only about 1/8 of the general antibody) and increases the affinity (about 1000 times that of the general IL-17 antibody drug), while the latter Greatly extend the half-life of the drug.
Because izokibep is produced in E. coli, its average single-dose cost is only about 1/20 of that of competing IL-17 antibody products.
Izokibep has successfully completed the second phase of the clinical trial for psoriasis in Germany.
Data from clinical trials for plaque psoriasis and psoriatic arthritis show that izokibep is effective in many cases including axial spondyloarthritis. It has great potential in indications.
(source:internet, reference only)