Karo Bio reports positive results for new glucose control compound
8 April 2009
Karo Bio’s (STO:KARO) compound KB3305, a liver selective antagonist
for the glucocorticoid receptor, shows clinically relevant and
statistically significant effects on plasma glucose levels in type 2
Karo Bio has concluded a clinical phase I program with the
anti-diabetes compound KB3305. The program consists of three parts. The
first part, where KB3305 was successfully given as increasing single
doses to healthy volunteers, was reported in April 2008.
Karo Bio has now completed the second and third parts which involved
repeated dosing to healthy volunteers and repeated dosing in a group of
type 2 diabetes patients, respectively.
In the second part of the phase I program, 24 healthy volunteers were
treated with KB3305 at doses up to 450 mg per day for a period of five
days. Tolerability and safety were satisfactory, and no serious adverse
events were recorded. The pharmacokinetic profile of the compound was
robust and predictable.
In the third part of the program, 14 patients with type 2 diabetes
were treated with up to 450 mg KB3305 per day over a period of 14 days.
A control group was given the corresponding placebo. The allocation to
each treatment group was randomized and blinded. Since KB3305 is a first
in class compound, the purpose of this study was to establish proof of
principle, ie to investigate if KB3305 has clinically relevant effects
on fasting plasma glucose levels in diabetes patients.
The results show a pronounced, clinically relevant, and statistically
significant lowering of fasting plasma glucose levels (compared to
baseline as well as against placebo) and also a statistically
significant improvement in glucose tolerance tests. The side-effect
profile was acceptable, and no serious adverse events were recorded.
Before initiation of phase II clinical trials, Karo Bio will evaluate
all existing data and make a decision regarding the need for further
optimization of the pharmaceutical formulation.
“KB3305 is a first in class compound, and with these results Karo Bio
confirms its capability to develop innovative and efficacious treatment
principles. The clinical results are consistent and pronounced, and
offer an excellent basis for further clinical development”, says Per
Olof Wallström, President of Karo Bio.
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