Allergan to begin phase 3 trials of Medytox’s ‘Innotox’ in US, Canada this week

Allergan will formally begin phase 3 clinical trials of Medytox’s Type A liquid-type botulinum toxin this week, as recruitment for the clinical study is slated to start Wednesday, according to data shown on ClinicalTrials.gov.

Allergan recently posted its clinical trial agenda for MT10109L on ClinicalTrials.gov. The third-phase clinical study aims to evaluate the safety and efficacy of the drug for the treatment of moderate to severe glabellar and lateral canthal lines, the firm said, referring to wrinkles on the forehead and extending from the outer corners of the eyes, respectively.

According to the post, Allergan’s study is expected to take place at 10 clinical sites in the US and Canada over two to three years. The estimated completion date is Jan. 1, 2021.

MT10109L, known as Innotox here, is the world’s first-ever liquid injectable BTX, and is currently approved and sold in Korea. Typically, BTX is created as a powder, a small amount of which is mixed with saline solution for clinical injections.

Allergan and Medytox struck a licensing partnership in 2013, when the Seoul-based company sold the global development and commercialization rights for Innotox to Allergan in a deal valued at up to $362 million.

However, Allergan did not initiate the drug’s phase 3 clinical trials in the years that followed, fueling concerns the US drugmaker was not interested in commercializing the injectable BTX drug.

In May this year, Allergan had confirmed it would start the last-phase clinical trials of Innotox within the fourth quarter of this year. The formal start of trials is expected to lift investor concerns over the global drugmaker’s commitment to Innotox.

Reflecting positive investor sentiment, shares of Medytox closed at 477,000 won ($419) on Monday, rising 9.15 percent from the previous trading session.

By Sohn Ji-young (jys@heraldcorp.com)