Helixmith Completes Enrollment of 43 Participants in Ngenesis US Phase 3-2 Clinical Trial

[Asia Economy Reporter Jang Hyowon] Helixmith announced on the 9th that it has reached the enrollment of 43 patients based on the start of dosing in the second US Phase 3 clinical trial (3-2) of the gene therapy ‘Engensis (VM202)’ for diabetic peripheral neuropathy (DPN).

Recently, the clinical trial has been accelerating as the enrollment speed has increased due to the expansion of COVID-19 vaccination sites and other factors in the US. Accordingly, the company expects to complete the enrollment of all patients within this year.

Helixmith conducted the first Phase 3 clinical trial (3-1, 3-1b) targeting DPN, and based on these results, is currently conducting the follow-up Phase 3 trials (3-2, 3-2b). In addition, the company is preparing to start the 3-3 trial.

In the DPN 3-2 trial, efficacy is being analyzed through pain reduction effects at six months after the first injection, and many other indicators are also being measured. The efficacy results are expected to be announced after the first half of next year. Separately from efficacy, a 12-month safety study has already started in the form of DPN 3-2b.

In this DPN clinical trial, the QDSS (Quantitative Data Surveillance System) is being used to systematically monitor the quality of pain data, effectively observing the data in real time. In particular, errors in measurement caused by subjects’ misconceptions, as well as excessive or insufficient deviations, are the main focus of observation.

The consistency and accuracy of the pain data from the 43 patients enrolled so far are at a very satisfactory level. The company evaluates that the decisive factor in achieving these results is the work capability and enthusiastic participation of the US clinical team CRA staff working on site.

Sunyoung Kim, CEO in charge of global clinical development, said, “Despite the difficult circumstances due to COVID-19, the Engensis clinical trial is progressing without any setbacks,” and added, “We will do our best to successfully operate the clinical trial to accelerate the commercialization of Engensis and enhance the value of the new drug.”