▷ ImmunoForge Inc. receives US FDA ODD for PF1801

30.10.2021 – 02:31


Seoul, South Korea; and Silver Spring, Maryland, Jan. 29 / PRNewswire /)

ImmunoForge (Co-CEOs Sung-Min Ahn, Kiho Chang), a company specializing in the development of new drugs for rare musculoskeletal disorders, announced that its new drug candidate PF1801, which is being developed for the treatment of Duchenne muscular dystrophy (DMD) and polymyositis (PM), has received the Orphan Drug Designation (ODD) from the US FDA for the treatment of polymyositis.

The FDA classifies solutions for rare, incurable or life-threatening diseases as orphan drugs. With the Orphan Drug Designation, ImmunoForge receives various benefits such as exemption from NDA / BLA application fees, tax credits for qualified clinical studies and exclusive rights for seven years after market approval.

Polymyositis is a disease in which muscles weaken due to an inflammatory response; the cause of the disease is not yet known. Duchenne muscular dystrophy (DMD) is a rare disease caused by the absence or alteration of a gene called dystrophin in which patients (usually boys) lose muscle, ultimately leading to death. Dr. Sung-Min Ahn, Co-CEO of ImmunoForge, said: “This designation as an orphan drug is important as it confirms the potential of PF1801 in the treatment of rare musculoskeletal disorders and we hope that patients those suffering from rare diseases, with the various new drugs we are developing, serve as a source of hope. “

This is the second time ImmunoForge has received an ODD for PF1801 from the FDA. Last year PF1801 received orphan drug status for the treatment of Duchenne muscular dystrophy (DMD) and for the polymyositis indication. The company is currently preparing for a PMDA pre-IND meeting with its Japanese partner and is in talks to conclude license agreements and technology transfers this year.

ImmunoForge recently closed Series B funding from several investment development companies and is preparing to manufacture and prepare for clinical trials of PF1801 drugs required for entry into Phase II clinical research overseas early next year Dates for IND approval by the FDA according to development schedules.

ImmunoForge also has a US office and has increased its global competitiveness through the hiring of Dr. Jim Ballance, who previously served as Vice President of PhaseBio, the original developer of PF1801, has been strengthened as President of the US subsidiary.

ImmunoForge is a company founded in 2017 by Dr. Sung-Min Ahn, director of the Gachon Genetic Science Research Institute at Gachon University Gil Hospital, and Kiho Chang, who has been developing new drugs and gaining experience in global technology transfer for over 25 years at Dong-A Pharmaceuticals, LG Life Sciences, and Anguk Pharmaceutical and aims to become a world-class company like Alexion in the rare musculoskeletal disorder. Kiho Chang, Co-CEO of ImmunoForge, said, “Based on the recent Series B funding and ODD clearance from the US FDA, ImmunoForge will drive and seek global clinical development and technology transfer for the new drugs Listing on KOSDAQ until 2023. ImmunoForge will become a global bio-venture in the rare musculoskeletal disorders for which there is currently no suitable treatment. “

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Original content by ImmunoForge, transmitted by news aktuell


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