Adocia (EPA:ADOC) has taken a step toward a planned Phase III trial of its combination of Eli Lilly's ($LLY) Humalog and Sanofi's ($SNY) Lantus. The latest hurdle to be cleared was a Phase Ib trial, in which Adocia's BioChaperone Combo triggered significantly bigger post-meal drops in blood glucose than Humalog alone.
|Adocia CEO Gerard Soula|
Lyon, France-based Adocia tested the combination in a double-blind crossover study that enrolled 28 people with Type 1 diabetes. The blood glucose levels of participants in the BioChaperone Combo arm fell by a greater amount in the two hours after eating than for the subjects who took Humalog, a result that meant the study met its primary endpoint. Publication of the data follows the release of positive results from an earlier study that looked at the effect of BioChaperone Combo over 30 hours. And with a Phase IIa dose-exposure study ongoing, the data behind the drug are poised to grow further.
More data on the combination drug are due before the end of the year, at which time Jefferies analyst Peter Welford thinks talks about a partnership for the product may intensify. Adocia has already struck a $570 million (€520 million) deal with Lilly for another of its assets, but for now it has full ownership of BioChaperone Combo. Management says it is comfortable with that situation. "There is no hurry to sign a partnership," Adocia CEO Gerard Soula told Les Echos. Adocia is sitting on around €70 million but has a Phase III diabetes trial looming into view.
"We are preparing the launch of the Phase III clinical trial by the end of 2016 or early 2017," Soula said. Late-phase diabetes trials typically carry hefty price tags and a significant global footprint, traits that suggest a Big Pharma partner would be beneficial. For those on the other side of the deal table, the potential is for BioChaperone Combo to carve out a slice of the multibillion-dollar market for insulin premix.
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- and Les Echos' take (French)