Gubra’s obesity drug trial success weighs on Zealand Pharma stock

Investing.com -- Shares of Zealand Pharma (CSE:ZELA) fell on Tuesday following the release of interim topline results from Gubra’s (CSE:GUBRA) multiple ascending dose (MAD) study of its investigational drug, GUBamy. 

These promising results have positioned Gubra favorably in the competitive landscape of obesity treatments, potentially affecting companies like Zealand Pharma, which is also involved in metabolic and obesity-related therapies.

According to Gubra’s statement, the first part of the MAD study, which assessed the safety and tolerability of GUBamy, demonstrated that the drug was well tolerated, with predominantly mild and gastrointestinal-related adverse events consistent with earlier findings from a single ascending dose (SAD) study.

The interim analysis focused on two cohorts receiving once-weekly doses of 1 mg and 2 mg of GUBamy for six weeks.

Gubra reported a dose-dependent mean weight loss, with the 2 mg cohort experiencing a statistically least squares (LS) mean weight loss of 7.77% on day 43. 

In contrast, the placebo group showed an LS mean weight gain of 1.99% on the same day. 

Gubra noted that the observed body weight loss trend aligned with data from the prior SAD study.

Furthermore, the study confirmed GUBamy’s favorable half-life of 11 days (270 hours).

"The interim topline results from the first part of the MAD study are very encouraging and builds upon and substantiates the results from the SAD study showing that GUBamy has potential to deliver significant body weight reduction with a favorable tolerability profile. We are very pleased with these results that have exceeded our expectations," said Henrik Blou, chief executive of Gubra in a statement.

The MAD part A study enrolled healthy lean and overweight individuals with a mean Body Mass Index (BMI) of 27.63 in the placebo group and 24.33 in the 2 mg GUBamy cohort. 

Participants were randomized in a 6:2 ratio to receive either GUBamy or placebo, administered once weekly at fixed doses for six weeks, followed by a six-week observation period.

Gubra indicated that the pharmacokinetic analysis supported the 11-day half-life. The company believes that these initial results from the MAD part A study warrant further development of GUBamy for weight management. 

The second part of the MAD study, which will test higher doses of GUBamy, is currently underway and progressing as planned, according to Gubra.