San Diego biopharma Elcelyx is crafting a revamped form of the ubiquitous diabetes drug metformin – and recently released some clinical data that illustrates its promise for the broader type 2 diabetes market.
Metformin is one of the most reliable and low-cost type 2 diabetes drugs in common use, but there’s a catch – about half the patients that take metformin report diarrhea and other gastrointestinal distress. And diabetics with kidney dysfunction are likely to develop a condition called metformin-induced lactic acidosis – which prevents a large patient pool from taking the drug.
“Metformin is really the most important product we have for type 2 diabetes,” CEO Alain Baron said. “Bt when patients for type 2 can’t take it, because of renal impairment or GI intolerance, there’s really no good substitute for that.”
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Elcelyx has formulated a delayed release form of the the drug, which is meant keep diabetic blood sugars down without adding the stomach upset – and keeping the kidney functioning safely. It just released data from Phase 2 testing that it’s well-tolerated and effective – and cuts down on the adverse effects.
The privately held Elcelyx has raised some $50 million to date. Though it’s wrapped up a Phase 2b trial, it’s going to conduct a more enhanced Phase 2 trial to address commercial doses – then head into Phase 3 trials by mid-2016. It’s planning for a PDUFA date in 2019.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Here’s why a delayed form of the pill might work out better: The standard and extended-release versions of metformin wind up circulating in the bloodstream, sending the drug all throughout the body. This increases the likelihood of developing GI and kidney distress.
Metformin DR, however, doesn’t come into effect until the pill reaches the distal intestine – and remains in the gut to reduce blood sugar. This reduces the systemic exposure of the drug, and allows for less of the drug to be used – since it’s working in a more targeted fashion, geographically.
A study published in Diabetes Care shows that in a 12-week trial with 240 patients, blood sugar levels dropped with Elcelyx’s Metformin DR at a comparable rate to an extended release form of the drug.
“We dramatically reduced the nausea and vomiting associated with high doses of metformin, and we believe that based on the data we have, this is very suggestive that we could reduce rates of diarrhea as well,” Baron said.
Some 20 percent of metformin users discontinue the drug because of these GI effects. Others have to quit because of renal impairment. But there’s really no good replacement for metformin, in terms of efficacy and cost.
“Patients prefer once-a-day pills to insulin shots,” Baron said. “We’ve done payor and market research, and found: There’s a great appetite for a metformin that addresses the population that can’t tolerate the drug in its current form.”
As diabetes rates continue to swell, biopharma companies are looking for more effective therapies. However, costs continue to rise. But while there’s a low-cost, generic form if metformin, it doesn’t work for many diabetics.
“Payors seem comfortable with this product being available to these patients at a price point that’s about the same as branded oral agents,” Baron said.
[IMAGE: Flickr user Nottingham Vets]
