In a space that is increasingly dominated by me-too products, French company Poxel is hoping that its first-in-class approach to type II diabetes, using glimins, might bring it success. The question now is whether the drug’s future is that of a stand-alone product or a combination with one of the existing stars of the space, or with generic metformin.
Thomas Kuhn, Poxel's chief executive, believes the drug’s versatility – which has seen it show promise with metformin and sitagliptin – means that the single life is unlikely. Speaking to EP Vantage, he says: “We have shown that imeglimin can be combined with the two main anti-diabetic products currently available on the market.” But while the drug appears to work well with other anti-diabetic products the real test, and key to success for Poxel, will be convincing a partner that this novel class of drug is worth taking a punt on.
Formed in 2009, the company is a direct result of Merck Serono’s 2007 decision to exit the increasingly heavily regulated primary care market, leaving its diabetes portfolio up for grabs. As an employee of the company Mr Kuhn was in a perfect position to take over the five compounds, which also include an AMPK activator.
So far Poxel has almost exclusively focused on moving imeglimin through the pipeline and this month reported positive results from a 12-week, 150-patient phase II trial, showing that a combination of imeglimin and sitagliptin caused a statistically significant 0.73% reduction in HbA1c, or blood sugar levels, compared with sitagliptin and placebo.
These results followed positive data from a trial in which the drug was combined with metformin, reported in April, and another, released last October, in which it was studied as a monotherapy.
Imeglimin is based on glimin, which differs from other diabetes treatments in that it acts at the mitochondrial level. The oral drug targets three key defects of type II diabetes: insufficient insulin production, excessive hepatic glucose production and impaired glucose uptake by skeletal muscles. It does this through oxidative phosphorylation inhibition.
This different mechanism of action means that glimins work well in combination. To date, the drug has also displayed a very clean safety and tolerability profile, something that could in future help it in the burgeoning diabetes treatment space.
However, moving imeglimin forward will involve ever-larger trials, something that will require an injection of funds in some form.
If Poxel decides to go it alone a fundraising will be inevitable. Mr Kuhn says the group’s current investors, which include Edmund de Rothschild Investment Partners, are keen to participate following their initial investment in 2010 (Serono spin-out Poxel raises €16m to fund phase II diabetes studies, July 8, 2010).
The size of a second funding round – and more importantly, the group’s ability to pull in new and high profile investors – would serve as useful indicator of whether others see promise in the drug.
Finding a partner has not been ruled out either. Given the increasingly high safety hurdles regulators on both sides of the Atlantic are placing on diabetes and the growing demand for ever larger trials, it could make sense for Poxel to partner the drug reasonably early in order to map out a clear regulatory pathway for imeglimin.
Additionally, as the drug is a first-in-class product and is therefore likely to face even more scrutiny from regulators, this might be a preferred option.
Mr Kuhn says that the group is in “regular discussions” with potential partners and adds that he believes imeglimin is an attractive target. “We have significantly de-risked the product, have a very solid patent status and have proved efficacy.”
But while its novelty makes it an attractive proposition, it also makes it an unknown quantity. In a space where more and more treatments are entering the clinic and cardiovascular safety hurdles are getting higher, prospective partners might prefer to sit on the sidelines and wait for more data. For now Poxel may have to continue its journey alone.
To contact the writer of this story contact Lisa Urquhart in London at firstname.lastname@example.org