Helixmith shares tank upon early termination of Phase 3 clinical trial in US

Helixmith shares lost further ground Monday after the Korean company announced early termination of a Phase 3 clinical trial of its gene therapy Engensis (VM202) for the treatment of diabetic foot ulcer (DFU) due to low progress in additional patient recruitment in the United States.

The company said in a regulatory filing last Thursday that the pivotal study first approved in 2015 had intended to recruit 300 patients, but only 44 were evaluated as of the data cut-off date of February last year.¡¯

Many patients were excluded due to strict screening criteria for the randomized, placebo-controlled Phase 3 study, this eventually led to a fewer number of subjects than planned, said Helixmith Co-CEO Kim Sun-young.

But the fact that more patients in the treatment group versus controls achieved remission is encouraging, Kim added. The remission rate achieved and maintained at month 5 was 63 percent in the treatment group, five to six times higher than the placebo group (p < 0.05). What is more significant is that although the ulcer size at baseline was smaller in the placebo group, the remission rate was higher in the Engensis treatment group, Kim emphasized.

Investors were not convinced. Shares of Kosdaq-listed Helixmith lost 7.09 percent to end at 32,100 won on Monday. They have lost more than 20 percent since Tuesday upon rumors of another setback in the much-awaited U.S. results.

Kim said Helixmith will launch a new Phase 3 study to evaluate the long-term clinical benefit of Engensis for the treatment of DFU for which there are no approved cures. In 2019, medical care used to mitigate DFU symptoms was estimated to be valued at $7.9 billion, while Americans spend about $45.7 billion due to diabetes-related foot problems per year.

Kim said a new Phase 3 study will be conducted in cooperation with a global big pharma and potential partners will be explored in the second half with a goal of study completion within two years and regulatory approval within three years.

[¨Ï Maeil Business Newspaper & mk.co.kr, All rights reserved]