A little over a year ago San Diego-based Elcelyx Therapeutics raised a $40 million E round to prove in a Phase IIb study that it had found a way to treat a large segment of diabetics who can’t be helped by or tolerate the standard treatment metformin.
This morning, the biotech said the gamble — with the money coming from a mix of Chinese and US investors, including Kleiner Perkins — paid off with positive data.
Metformin DR is targeted at the lower small intestine so that it can be used to treat patients with renal impairment or who can’t tolerate the current metformin formulations. And in the study the drug arm achieved statistically significant reductions of HbA1c at 16 weeks, Elcelyx says, though the company didn’t spell out the data.
Diabetes is a big field, but one that is only rarely tackled by the biotech crowd, which can find it hard to get the financial backing needed to see projects through Phase III. Elcelyx says it now knows what doses of reformulated Metformin to take into Phase III, but it didn’t say exactly how it plans to pay for the kind of large late-stage program that regulators insist on.
There were also a few caveats to note on the company’s statement:
The glycemic effect of Metformin DR was somewhat less than that seen with a maximally effective dose of metformin immediate release (IR), but with significantly and disproportionally lower systemic exposure. The subgroup of subjects who completed the study and adhered to all protocol requirements showed a pattern of glycemic improvement comparable to that seen with the overall study population.
Three years ago, when the company broke stealth cover, CEO Alain Baron told me that the company had big plans for NewMet, along with a dietary supplement in development that was later sold off. Baron is a former senior VP of research at Amylin, which was bought out by Bristol-Myers Squibb $BMY. Its $40 million round was led by the Hong Kong-based private equity investor Sailing Capital.
“Patients with type 2 diabetes whose advanced kidney disease prevents them from effectively clearing metformin from their circulation are at increased risk for potentially toxic metformin-associated lactic acidosis,” said Robert Henry, MD, professor of medicine at the UC San Diego School of Medicine. “Gut-mediated Metformin DR which has minimal absorption leading to lower systemic exposure with clinically relevant glucose lowering effects is an especially attractive proposition for the treatment of type 2 diabetes patients with renal impairment, as well as for patients unable to take full doses of metformin due to gastrointestinal side effects.”
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