Helixmith is facing additional delays in receiving a recommendation from the Independent Data Monitoring Committee (IDMC) for its U.S. phase 3 clinical trial of Engensis (VM202), its diabetic peripheral neuropathy (DPN) treatment.
Industry sources said the IDMC interim results could predict whether the phase 3 clinical trial was successful.
The company had planned on announcing the recommendation by the end of July. However, with the IDMC yet to provide a recommendation, the company said it was unsure when it will receive the results.
"We haven't received a letter from the IDMC yet," a company spokesperson told Korea Biomedical Review on Tuesday. "While the company has continued its communication with the IDMC, the schedule for IDMC's recommendation process is beyond the company’s control."
The company's explanation follows a previous setback in June.
Helixmith had initially planned to announce IDMC's recommendation, which was going to be one of the following outcomes -- clinical continuation, clinical scale revision, and clinical suspension – during a news conference on June 28.
However, the company had to postpone the announcement as the IDMC requested additional data.
"It is not unusual for the IDMC to request additional data as it requests such data from time to time," Helixmith CEO Kim Sun-young had said. "The additional data requested is for general safety, and efficacy data frequently discussed during the data analysis process and did not mean that there's a problem."
He had also said that the company was discussing with the IDMC to receive interim results in July.
CEO Kim recently rolled back on his comments in an official newsletter last Friday, saying that his expectations of receiving an IDMC recommendation within July were based on general industry practices and customs. He said it was difficult for the company to receive a recommendation at the time it wishes.
While the company could not provide an expected timeline on when the IDMC will release its results, the spokesperson stressed that the company will disclose the information on Financial Supervisory Service's Data Analysis, Retrieval and Transfer (DART) system as soon as they receive the recommendation.
The company will have to disclose the IDMC's recommendations regardless of the decision due to a Korea Exchange (KRX) recommendation last month.
"While companies normally only have to disclose a clinical suspension recommendation when disclosing interim results, the KRX recommended that the company disclose the recommendation regardless of the decision as the progress of the DPN phase 3-2 clinical trial has attracted attention from investors and the results may have an impact on investment decisions," the company said.
Meanwhile, the company's stocks have been sliding since it announced IDMC's postponement of announcing its result on June 28. As of 10:35 a.m. Tuesday, the company's shares stood at 17,500 won ($13.39), down 20.81 percent from June 28.