It's no surprise to our readers that one of the biggest issues with current diabetes management is the lag time of our current fast-acting insulins.
Although light years ahead of what patients had in the past, current fast-acting insulins still aren't quite up to snuff to handle post-prandial spikes. This is becomes a barrier for developing an Artificial Pancreas, as the insulin can't respond quickly enough to sensor data in a closed-loop system.
The topic of potential solutions to this problem was much-discussed at the ADA Conference this past week. (We also spoke with Dr. Sanjoy Dutta, Director of Glucose Control Therapies at the JDRF about this at the JDRF Insulin Initiative in New York City a few weeks ago.)
At the ADA Conference this weekend, a company called Halozyme created a lot of buzz presenting promising data on new "ultrafast" insulin action.
I had the opportunity to meet with the CEO of Halozyme, Gregory Frost, after the company presented results from a Phase 1 trial of its enzyme, called recombinant human hyaluronidase (rHuPH20) combined with Novolog. The study showed that using the enzyme with Novolog in an insulin pump did in fact speed up the insulin action, as compared to insulin alone, with the majority of the insulin hitting the system within two hours. The trial also took biopsies of patients' skin after using the drug, and showed that patients did tolerate the enzyme.
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Halozyme's product is called Aspart-PH20 and it is a sister drug to the already FDA approved (!) Hylenex, a human formulation of hyaluronidase.
In diabetes, the company has found that Aspart-PH20 can speed up insulin action by decreasing the amount of time it lags under the skin before penetrating. This can happen in two potential ways: either when used independently, or integrated with an existing insulin, like Novolog.
The way it's currently being envisioned for use is in folks with pumps (tubed-only, sorry); patients will inject the enzyme through the cannula of the set, and the enzyme will work directly under the skin to enhance absorption. The enzyme appears to work consistently for three days under the skin, and then a patient would repeat the process during the next site change. The second option is to combine the insulin and the enzyme, but since that would essentially require creating an entirely new drug to go to market, that option would take much longer.
Data from Halozyme's first clinical trial data was presented in 2009, and showed that the enzyme helped speed up insulin action with Regular insulin and lispro. The goal is to have insulin action more precise, so that you know exactly when insulin kicks in and when it's out of the system, rather than our current system of guess-timations.
In other words, PH20 has the potential to create better BG control, because insulin action supposedly becomes more predictable.
The CEO Frost explained that Halozyme hasn't had the same challenges as other enzymes because it is already FDA approved, but they are still conducting several clinical trials to show safety and efficacy. "We want to make sure interaction of each therapy is well understood. We have to be thoughtful with that," he explains. "The most important thing is that we're building safety in this area."
Halozyme is prepping to release data from another clinical trial for later this year involving people with type 1 and type 2 diabetes, which has lasted a year. Frost expects to present the data at next year's American Diabetes Association's Scientific Sessions in Philadelphia. He says they are looking at a 2013 launch (at the earliest) for the enzyme add-on therapy, and who-knows-when for the enzyme/insulin combo.
"If this is going to make patients' lives better, then it's meaningful and valuable," Frost says. "We think helping to get the roller coaster smoothed for people is a good thing."
Hear, hear! Empathetic words from a CEO.
We're looking forward to seeing more solutions in the fast lane!