BioWorld International Correspondent
LONDON - Shares in Alizyme plc shot up 34 pence to £1.14 Friday when the company announced Phase IIb results for ATL 962, showing the drug is as effective in promoting weight loss as other lipase inhibitors, but with far fewer distressing side effects.
"We're absolutely delighted; these are fantastic results," Finance Director Tim McCarthy told BioWorld International. "If we'd said before we got the results what we wanted them to be, they wouldn't have been as good as these."
In the placebo-controlled trial involving 372 clinically obese subjects, there was statistically significant weight loss in all three dose groups over placebo. The effect on weight was similar to that achieved with other lipase inhibitors, but the occurrence of gastrointestinal side effects including diarrhea and fecal incontinence was lower. In the three-month trial the average number of adverse events in the treated groups was 3.8 per patient, and they were generally mild in severity.
There also were statistically significant improvements in cholesterol levels in all treatment groups.
"The product profile shows comparable efficacy to Xenical [F. Hoffmann-La Roche Ltd.'s lipase inhibitor] and on the side effect/tolerability profile of GI-related events - which is the Achilles' heel of Xenical - we got up to 90 percent reductions," McCarthy said.
Cambridge-based Alizyme is now preparing for Phase III as it seeks a licensing partner for the U.S. and Europe. "Companies have expressed an interest in it, and once we share the detailed data on Phase II we will see how many continue to be interested. I expect it will be quite a few," McCarthy said.
In August, Japanese rights to ATL 962 were licensed to Takeda Chemical Industries in a US$42 million deal. McCarthy said Takeda now will have access to the Phase IIb data to decide whether to initiate a clinical program in Japan. "If they go ahead, this will trigger another milestone payment."
McCarthy said it is not clear yet how many subjects will be needed in Phase III. "There are different ways to go here, because there is also a diabetic indication and we may do Type II diabetes separately."
It is too early to assess the overall commercial significance of the ATL 962 results for Alizyme. "There's no more money today. The next task is to make sure the potential [of the compound] is reflected in the license terms," McCarthy said. "We've got some very robust Phase II data on a large trial. This will stand us in good stead."
It is expected that the licensing deal for ATL 962 will secure the future profitability of the company. "We don't anticipate going back to the market [for more money]," McCarthy said. "Of four products Alizyme has in the clinic, three are now qualified for Phase III; R&D spend is going down and simple math says deals will put us in cash-positive territory."