Roche shares fall as side effects prompt early-stage study of obesity pills By Reuters

FRANKFURT (Reuters) – Shares in Roche fell on Thursday after an early-stage obesity pill candidate that has high hopes for the market was linked to a high rate of temporary side effects in its initial phase of testing on people.

Roche shares fell 4 percent at the open at 0700 GMT after the company presented details of the lawsuit late on Wednesday. A brief summary of the trial’s success in July boosted the Swiss drugmaker’s share price.

According to a presentation at a meeting of the European Association for the Study of Diabetes in Madrid, all 25 study participants experienced mild or moderate side effects, or adverse events in industry parlance, including those who received only an ineffective placebo.

Side effects of the drug known as CT-996 — part of Roche’s $2.7 billion acquisition of Carmot in December — were mostly gastrointestinal (GI), like those associated with similar drugs.

Analysts at Barclays and Jefferies described the number of adverse events as high, mirroring similar data on another early-stage experimental weight-loss drug from Roche.

“In our view, investor enthusiasm for Roche’s obesity franchise may take a pause, given that both acquired assets have shown higher-than-anticipated GI side effects,” Jefferies analysts said.

In terms of efficacy, Roche said the once-daily CT-996 pill resulted in an average placebo-adjusted weight loss of 6.1 percent over four weeks in obese patients without diabetes.

The Phase I study is said to have followed a convention of increasing the dose of the drug, a process known as titration, faster than planned for later stages of the study to quickly catch any unanticipated side effects.

The frequency of adverse events was “consistent with rapid titration and the early stage of development,” Roche said.

“These data support continued investigation of CT-996 in studies of longer duration, with larger sample sizes and slower titrations,” the company said.

Roche also said Wednesday that the main result of 6.1 percent weight loss in four weeks was based on just six patients, underscoring the uncertainty of the development project.