Xenetic Biosciences announces positive topline phase 1 results for its GLP-1 glucagon dual agonist – May 21, 2014

Massachusetts-based Xenetic Biosciences recently announced positive topline phase 1 results for its GLP-1/glucagon dual agonist PSA-Oxyntomodulin. For background, oxyntomodulin is a naturally occurring human hormone that has been shown to increase energy expenditure, reduce food intake, and reduce body weight. The phase 1 trial was conducted in Russia by Russian partner OJSC Pharmsynthez, and found that four different dose levels of PSA-Oxyntomodulin (0.25 – 1.5 mg/kg) were safe and well-tolerated in a small study (12 healthy volunteers). Xenetic’s partnership with OJSC Pharmsynthez represents an example of a model of working to de-risk early-stage drug development, allowing Xenetic to collect (at least some) clinical data and better understand its candidate’s potential before investing in filing an IND with the US FDA. As per the companies’ agreement, Xenetic has the right to use any pre-clinical and clinical data conducted by OJSC Pharmsynthez to develop and commercialize PSA-Oxyntomodulin outside of Russia and its Commonwealth of Independent States (eight regional neighbors including Armenia and Belarus), in exchange for providing OJSC exclusive rights to develop and commercialize the drug inside the Russian Commonwealth. Other companies developing GLP-1/glucagon dual agonists include Lilly (TT401 in phase 2 and an oxyntomodulin in phase 1), Prolor/OKPO (preclinical long-acting oxyntomodulin), and Zealand Pharma/BI (Zealand now in sole control of phase 1 ZP2929; new lead candidate being selected for BI partnership). We will be interested to learn the dosing interval for Xenetic’s candidate, as that will likely be an important differentiating factor within this budding class; obviously it will be critical to see larger groups studied who are patients – this was an interesting starting point.