Inventage Lab is inviting gossip in the market by releasing news material different from facts about its clinical trials of new drug candidates.

Inventage Lab’s CEO, Kim Ju-hee
Inventage Lab’s CEO, Kim Ju-hee

On Monday, the company, a microfluidics-based drug developer, distributed a news release headlined, “Applying for phase 1 clinical trial in Australia for long-lasting injection to treat alcohol and drug addiction.”

In the press release, Inventage Lab explained that it had submitted an investigational new drug (IND) application for a phase 1 clinical trial of IVL3004, a long-lasting injection to treat alcohol and narcotics addition to Australia’s Therapeutic Goods Administration (TGA).

After the news release, the company’s stock prices rose to 10,000 won ($7.8) per share at 11:30 a.m. Monday, up 300 won, or 3.09 percent, from the previous trading day.

However, according to some sources, Inventage Lab’s application is under review by the Human Research Ethics Committee (HREC), a preliminary stage to screening by TGA.

Unlike Korea and the United States, Australia operates a Clinical Trials Notification (CTN) system. In Korea and the U.S., regulators – the Ministry of Food and Drug Safety (MFDS) and the Food and Drug Administration (FDA) – directly review and approve IND applications. However, applicants can enter clinical trials in Australia without TGA’s approval if only they pass HREC’s screening.

Moreover, Inventage Lab submitted phase 1 trial IND of IVL3004 as early as Nov. 30, which the company announced through a public filing on Dec. 8.

According to the sources, which wanted to remain anonymous for privacy, the latest news release could confuse investors as if the company had entered a phase 1 clinical trial.

Asked to comment on such criticism, Inventage Lab said, “Considering that Australia’s clinical trial approval system is different from Korea and the U.S., we wrote in TGA instead of HREC to help readers understand it more easily.”

 

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