The Phase 3 Trial in Diabetic Peripheral Neuropathy May Have Failed Due to a Critical Mistake

 

FierceBiotech recently reported that Helixmith Co., based in Korea and previously known as ViroMed, coordinated a Phase 3 clinical trial involving five hundred diabetic peripheral neuropathy (DPN) patients.

The therapy tested was VM202 (Engensis) administered to one DPN group four times during a nine-month period via intramuscular injections. The second DPN group was injected with a placebo during the same time period.

About the VM202 Clinical Trial (NCT02427464)

The VM202 therapy is a DNA plasmid (a segment of DNA) that encodes for the hepatocyte growth factor (HGF) which is a gene that promotes cellular growth, homeostasis (stable internal environment) and regeneration.

Through the development of VM202, Helixmith intends to control:

  • Angiogenesis (growth of new blood vessels) and
  • Neurotrophic properties which involve the metabolism and nutrition of cells by the nervous system.

If successful, the therapy will control the properties of HGF and lessen the nerve damage of DPN, which in turn would alleviate the severe pain associated with the disorder.

About the Primary Endpoint

The company stated that samples from the placebo group were analyzed and contained the DNA that was used in VM202. This is an indication that the investigators had mistakenly given an unknown amount of VM202 to subjects in the control (placebo) group instead of administering 100% of the placebo.

In addition, upon analysis, the investigators found that some of the patients in the VM202 group had much lower VM202 concentrations than the other patients in that same group.

Initial Trial  Results

The initial result of the trial found that VM202 did not surpass the placebo in the reduction of pain. The company mentioned the possibility that there may have been a problem with administering the therapy.

At first, Helixmith sent out a release explaining that it is not always possible to find the exact cause or reason for certain endpoints.

The release was followed by a press conference. The Korea Times was in attendance. At the press conference, the company’s CEO gave an expanded explanation saying that due to an error in administering VM202, the patients in the placebo group experienced pain relief. However, the reverse occurred in the VM202 group.

The goal of the study was to enroll well under five hundred patients at twenty-five sites in the United States. Helixmith’s CEO believes that the spike in enrollment may have compromised the trial’s management.

The company now has a team that is investigating the findings. Helixmith has plans for two or three smaller trials that will generate additional VM202 data. The results are expected by 2022.

Looking at the VM202 problems from a broader perspective, it is another major setback for Korea’s biotech industry. Several other Korean companies had major setbacks in 2019 that wiped out sizeable amounts of their multibillion-dollar bio stocks.

What are your thoughts about the VM202 clinical trial?


 

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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