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news.Canadian drug developer ConjuChem has seen its stock balloon by more than 20% after announcing positive preliminary results from a phase I/II trial of its type 2 diabetes treatment candidate, PC-DAC:Exendin-4.
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Preliminary data from the phase I/II single escalating dose clinical study demonstrated an excellent tolerability profile and positive efficacy on glucose reduction supporting once-a-week dosing.
Furthermore, the longer then expected half-life of the drug and duration of glucose reduction suggest that an even longer dosing interval may be possible.
There were no safety or tolerability issues reported in the first four cohorts (310, 620, 1250 and 2500 microgram doses). At the 5000 microgram cohort, symptoms linked to an over-stimulation of the GLP-1 receptors were observed as a result of the rapid decrease in blood glucose.
In each of the 3750 and 5000 microgram cohorts, there was one mild and transient case of short-term gastric stasis; no anti-emetic medications were needed for either of these cases nor were any anti-emetics needed throughout the trial.
As a result of the longer than expected half-life of the drug and the longer than expected duration of glucose reduction, ConjuChem said that it will move aggressively to a multi-dose phase I/II program where the compound will be administered once-a-week (and potentially less frequently) at various dosages for one month.
Final data analysis from the current trial will be available in the third quarter.