Immunoforge's 'PF1801' Is Designated as Orphan Drug by FDA
Immunoforge's 'PF1801' Is Designated as Orphan Drug by FDA
  • PR Newswire
  • 승인 2021.01.28 23:00
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SEOUL, South Korea, Jan. 28, 2021 /PRNewswire/ -- Immunoforge, the company specializing in the development of new drugs for rare musculoskeletal diseases (Representatives: An Seong-Min and Jang Gi-Ho), announced that their new drug candidate PF1801 has been designated as the FDA orphan drug for treatment of the Duchenne muscular dystrophy on January 25.

As the orphan drug designation awardee, Immunoforge will be granted the following benefits from the FDA: waiver of qualified clinical trials costs and FDA expedited review during clinical trials for the Duchenne muscular dystrophy, as well as 7-years of exclusive right on marketing upon market approval.

Immunoforge plans to obtain approval from the US FDA for phase 2 clinical trials of the Duchenne muscular dystrophy and promote clinical trials in the second half of 2021, thus it has established a branch office in the United States. Dr. Jim Ballance has been assigned to the president of the US branch, who was vice president of PhaseBio which is NASDAQ listed company, and led the development of various new drugs at PhaseBio, including PF1801. Immunoforge is developing agents for rare muscle related diseases, such as Duchenne muscular dystrophy, polymyositis, and inclusion body myositis, based on its patent with PF1801 from PhaseBio, which has completed phase 2 clinical trials

Immunoforge is a company co-founded in 2017 by An Seong-Min, the Director of Gacheon Genome Medical Research Institute, Gacheon University Gil Hospital, with Jang Ki-Ho, who has developed new bio drugs for over 25 years at Dong-A Pharmaceutical, LG Life Science, and Ahn-Gook Pharm, having rich experience in global technology transfer. It aims to grow into a global company like Alexion in the field of rare musculoskeletal diseases.

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