Donaperminogene seltoplasmid is under clinical development by Helixmith and currently in Phase III for Diabetic Neuropathic Pain. According to GlobalData, Phase III drugs for Diabetic Neuropathic Pain have a 63% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Donaperminogene seltoplasmid’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Donaperminogene seltoplasmid overview
Donaperminogene seltoplasmid (VM-202) is under development for the treatment of critical limb ischemia, painful diabetic peripheral neuropathy, coronary artery disease, Charcot-Marie-tooth disease type I A, amyotrophic lateral sclerosis, claudication. It is administered through intramuscular route (percutaneous transendocardial). It is a genomic-cDNA nucleic acid hybrid of human HGF gene, which expresses two isoforms of HGF, namely HGF and dHGF by way of alternative splicing. For construction of VM-202, HGF-X7 was inserted into pCK DNA vector. VM-202 consists of the proprietary pCK vector encoding the engineered hepatocyte growth factor gene. It was under development for the treatment angina pectoris, acute myocardial infarction, coronary artery disease, peripheral artery disease, diabetic ischemic foot ulcers and myocardial ischemia.
Helixmith overview
Helixmith, discovers and develops DNA, protein-based therapeutics, herbal medicines and nutraceuticals for treating various ischemic diseases or neurodegenerative disorders. The company developed Engensis (VM202), a plasmid DNA therapy used to express two isoforms of hepatocyte growth factor and treat various neurodegenerative diseases such as diabetic peripheral neuropathy, diabetic foot ulcer and coronary artery disease. It develops VM206 program for treating breast cancer and VM501 program against thrombocytopenia, a deficiency of blood platelets caused due to chemotherapy. Helixmith also investigating various programs to treat chronic wounds, peripheral arterial diseases and claudication. The company uses plasmid DNA (pCK) and AAV vector technology to treat neuromuscular and muscle diseases. It has a manufacturing facility in San Diego, California, the US. Helixmith is headquartered in Seoul, South Korea.
For a complete picture of Donaperminogene seltoplasmid’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.
