FRANKFURT, Sept 12 (Askume) – Roche (ROG.S) shares fell to a two-month low on Thursday after a highly anticipated weight-loss experimental drug failed in early human trials. The incident related.
Roche shares were down 3.5% by 0940 GMT, the second-biggest fall in the pan-European STOXX 600 index (.STOXX), following the company’s losses on Wednesday .Details announced for trial of once-daily CT-996 pill .
The Swiss drugmaker’s shares got a boost from a brief summary of the July study results .
All 25 participants in the trial experienced mild or moderate side effects, or adverse events in industry terms, according to a report from the European Association for the Study of Diabetes meeting in Madrid, including only non-infectious placebo participants.
Side effects of Carmot, which Roche bought in December for $2.7 billion, were mainly related to the gastrointestinal (GI) tract, as was the case with similar drugs.
However, it also saw an increase in heart rate of up to 15 beats per minute, which Roche said was in line with other drugs in this class. Still, analysts at JPMorgan said it was still worrying because any effect on heart health would be a significant differentiator in a competitive market.
Analysts and peers at Barclays and Jefferies underestimated the total number of adverse events.
Roche’s data on another early-stage Carmot program, injectable CT-388, released on Monday, also weighed on its shares, which are down 5.4% so far this week.
Analysts at Jefferies said: “We believe investor enthusiasm for Roche’s obesity franchise may have waned as both acquired assets have shown greater-than-expected gastrointestinal side effects.”
Phase 2 trials will begin next year
On the efficacy front, Roche reiterated its claim in July that once-daily dosing of CT-996 resulted in a placebo-adjusted average weight loss of 6.1% over four weeks in obese patients without diabetes.
It said the Phase 1 trial followed the convention of increasing the drug dose at a faster rate than the rate prescribed for subsequent trial phases, known as titration, to avoid rapid detection of any unexpected side effects.
Roche said the frequency of adverse events was “consistent with rapid growth and the early stages of development”.
“These data support the continued investigation of CT-996 in long-term studies with larger sample sizes and slower titration,” the company said, adding that the second of three trial phases will begin next year.
But JPMorgan analysts warned that slow progress in key trials could prevent the market from repeating July’s sharp weight losses.
“Regarding tolerance … this may be difficult to overcome without a significant reduction in efficacy,” they said in a report.
Novo Nordisk NOVO Nordisk NOVO.CO , the weight-loss market leader owned by Eli Lilly, said in an update on Wednesday that its experimental drug has mild to moderate side effects, making it even more popular with investors.
Roche also said on Wednesday that the main result of 6.1% weight loss over four weeks was based on just six patients, underlining the uncertainty surrounding the development.
