Roche says early-stage obesity pill results were based on just six patients
Adds detail of trial in paragraph 6, company comment in paragraph 7, further detail in paragraphs 8-10
FRANKFURT, Sept 11 (Reuters) -Roche ROG.S said on Wednesday the promising results of an early-stage trial of its experimental weight-loss pill that bolstered its shares in July were based on just six patients, underscoring the uncertainty of the development project.
The Swiss drugmaker said in July that the once-daily pill CT-996 resulted in a placebo-adjusted average weight loss of 6.1% within four weeks in obese patients without diabetes in a Phase I trial.
Presentation slides published on Wednesday showed that while the trial involved 25 participants overall - six of which were given an ineffective placebo for comparison - the result summary was taken from the best-performing of the three other subgroups on the experimental treatment.
The second-best-performing subgroup, which had seven volunteers, reached an average placebo-adjusted weight loss of 4.6%, the data showed.
The company reiterated that larger trials in the second of three development stages would start next year.
It said the Phase I trial followed a convention of ramping up the drug dose, a process known as titration, faster than is planned during later trial stages, in order to uncover any unforeseen side effects early.
"These data support the continued investigation of CT-996 in studies of longer duration with larger sample sizes and slower titrations," the company said in a presentation held at a meeting of the European Association for the Study of Diabetes in Madrid.
Roche in December agreed to take over the drug's developer Carmot for $2.7 billion upfront, joining the race to challenge the dominant makers of weight-loss injections Novo Nordisk NOVOb.CO and Eli Lilly LLY.N.
The emerging new generation of gut-hormone drugs for weight loss, which some analysts predict will generate $150 billion by the early 2030s, are initially given at low starter doses and the concentration of active ingredient is then increased over weeks or months.
The best-performing subgroup in Roche's trial was one of two cohorts where the dose ramp-up ended at 120 mg of CT-996 per day, while a third cohort ended at 90 mg.
Reporting by Ludwig Burger; Editing by Matthias Williams and Jan Harvey
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