[BioUSA] Kim Sun-young "Enzygnis Phase 3-2, Interim Results Announcement Next Month"

FDA Monitoring Committee Recommendations Announced
"Means There Is Potential Unless Clinical Suspension Is Recommended"

Kim Sun-young, CEO of Helixmith / San Diego (USA) = Photo by Lee Chun-hee

[San Diego (USA) = Asia Economy Reporter Lee Chun-hee] Kim Sun-young, CEO of Helixmith, announced that the interim results of the Phase 3-2 clinical trial for the gene therapy drug 'Engensis (VM202)' under development will be disclosed next month.

On the 15th (local time), near the San Diego Convention Center in California, USA, where the '2022 BIO International Convention (BIO USA)' is being held, CEO Kim said, "The interim results of Engensis Phase 3-2 will be released in mid-next month." Engensis is one of Helixmith's core pipelines. Currently, a Phase 3-2 clinical trial for diabetic peripheral neuropathy (DPN) is underway.

The interim results mentioned by CEO Kim refer to the interim recommendation from the Independent Data Monitoring Committee (IDMC), which the U.S. Food and Drug Administration (FDA) recommends forming, expected to take place next month. The IDMC is an objective independent committee operated to ensure safety and scientific validity during clinical trials. It makes recommendations to the clinical trial sponsors on whether to 'continue the trial,' 'modify the trial design,' or 'stop the trial' during the clinical process.

This interim result is based on data from 76 patients, half of the 152 patients set for the Phase 3-2 clinical trial. In this case, the IDMC's recommendation is expected to be one of three options: 'continue the trial with 152 patients,' 'adjust the patient size,' or 'stop the trial.' Helixmith stated, "The clinical plan is already designed to extend the Phase 3-2 trial up to 250 patients," adding, "Unless there is a recommendation to stop the trial, the likelihood of success for Phase 3-2 is high."

CEO Kim cited exploring various technologies as the reason for visiting BIO USA this time. He said, "Engensis is almost at the end of development," and emphasized, "Currently, there are about four candidate substances within the company, but since there is no guarantee of success, we need to build a pipeline going forward." He explained that the visit was also to actively review technology imports (license-in) candidates that could support the technologies currently under development and enable the construction of additional pipelines.

CEO Kim also showed support for the plasmid DNA (pDNA) among the three major gene therapy platforms Helixmith is promoting. He said, "Although gene therapy is gaining attention thanks to chimeric antigen receptor (CAR)-T therapies and adeno-associated virus (AAV), pDNA is newly attracting attention," emphasizing that "the difficulty of manufacturing quality analysis and control is low, while clinical efficacy and safety are the highest."

Finally, CEO Kim hinted at plans to hold a briefing session for reporters and shareholders around the time the Phase 3-2 interim results are released next month.

San Diego (USA) = Reporter Lee Chun-hee spring@asiae.co.kr