Belief BioMed (BBM), an innovative biotechnology company focused on developing cutting-edge gene therapies, today announced that it has received National Medical Products Administration (NMPA) clearance of an Investigational New Drug (IND) application for BBM-D101, the company’s Duchenne Muscular Dystrophy (DMD) gene therapy candidate. Thus far, the IND for BBM-D101 has been approved by both NMPA and the Food and Drug Administration (FDA) of America.
Dr. Xiao Xiao, Co-founder, Chairman and Chief Science Officer of Belief BioMed, said, “We are pleased to share the good news of the NMPA’s IND clearance of BBM-D101. We appreciate the NMPA’s review of the IND and look forward to continuing to work in collaboration with the agency to carry out clinical trial. Previously, it has been obtained IND clearance by FDA. We will accelerate the progress of clinical research to bring new treatment options to DMD patients as soon as possible.”
This clinical trial is an open label and single-dose clinical study, which was designed to evaluate the safety and efficacy of a single intravenous infusion in DMD patients aged 4-9 years old. Due to engineered capsid, BBM-D101 has a higher efficiency to transduce muscle tissue. Therefore, the proposed clinical dosage is lower than the approved similar adeno-associated virus (AAV) gene therapy products, and BBM-D101 is expected to have good safety.
What is BBM-D101 Gene Therapy?
BBM-D101 is an AAV-based gene therapy with independent intellectual property rights owned by BBM. Based on engineered AAV vector, it is single intravenously administered to deliver the optimized gene into muscles of whole body, thereby achieving “one dose, long-term effect” treatment of DMD.
Learn More: New Gene Therapies for Duchenne Muscular Dystrophy
What is IND Clearance Means?
An Investigational New Drug Application (IND) is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. (Read more: Meaning of IND Clearance)
