IND Approval for PN-101 by MFDS
PAEAN Biotechnology, a company specializing in the development of new mitochondrial drugs, announced today that the Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug (IND) application for its lead product, PN-101 the world’s first allogeneic mitochondrial drug candidate for the treatment of polymyositis and dermatomyositis. PN-101 is the first-in-class drug where the main component consists of mitochondria isolated from stem cells.
The approved trial design will be a prospective open, dose-escalation, single-center phase I/IIa trial to evaluate the safety, tolerability, and efficacy of PN-101 in patients. Clinical trials will be conducted at Seoul National University Hospital for up to 18 patients.
Polymyositis and dermatomyositis are categorized as rare diseases, where the approved treatments such as steroids, immunoglobulins, and steroid-sparing drugs (e.g., immunosuppressants and immunomodulators) have been used. Patients who do not receive the treatment due to side effects of steroids or immunosuppressants, or who do not respond to the steroids, urgently need a novel treatment.
Kyuboem Han, CEO of PAEAN Biotechnology mentioned, “With the approval of the PN-101 clinical trial by the MFDS we will accelerate the development of indications in future for the mitochondrial-related incurable diseases. We plan Series B funding in the second half of this year to secure the necessary clinical development costs and further development of other mitochondrial drug candidates”. In addition, he said, “We recently completed a brand new GMP facility for clinical trials in Seoul office. Using this GMP facility, we will focus on clinical trials and commercialization of mitochondrial drugs.”