We all know how scary emergency glucagon kits can be -- and for God's sake, who wants to face a complicated nine-step mixing process when your PWD loved one is passed out on the floor?!
Thankfully, the race is on to develop the next generation of rescue glucagon to replace the powder + syringe mixes housed in those red and orange plastic cases made by Eli Lilly and Novo Nordisk. And we're beginning to see some progress in clinical trials to make these new soluble glucagon options a reality. By the end of next year, we may actually have or be extremely close to having a glucagon product that looks and feels more like an Epi-Pen.
The concept isn't new; products like Enject's promising GlucaPen and the freeze-dried version GlucaGo have created buzz over the last few years, but are either stuck in limbo or have faded completely.
These days, when you look up "stable glucagon" you'll find a roster of those racing to market: Connecticut-based Biodel, developing a liquid glucagon solution; Latitude Pharmaceuticals in San Diego, CA, creating the Nano-G formula; the starup Enject still developing the GlucaPen; and Xeris Pharmaceuticals in Austin, Texas, pursuing an entirely new line of glucagon products that some experts seem to think is the best bet.
Last year, the Helmsley Charitable Trust gave Xeris a nearly $1 million grant to develop its liquid glucagon, which followed a $1.14 million grant from the National Institutes of Health. And then last summer, the JDRF teamed up with Xeris and Latitude focusing on the pumpable type of glucagon for use in ongoing Artificial Pancreas trials.
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This is what Xeris is working on, in a nutshell:
- G-Pen, an auto-injector pen containing a single 200-unit dose of the company's stable glucagon formula.
- G-Pen Mini, which contains the same formula of stable glucagon but is designed to allow smaller, multi-doses that can treat moderate hypos instead of the one-time quick boost.
- G-Pump glucagon, which will go inside an infusion pump and be dosed when blood sugars are low or dropping quickly. They have three lines of this category: a glucagon that could go into a dual chamber pump working with a CGM to create an artificial or "bionic pancreas" system; one that would go into a glucagon-only pump that might be even more ideal for those at higher risk for hypos; and glucagon that would go into a dual chamber pump that would dose it more like a basal over the course of 24 hours, addressing more serious health issues such as congenital hyper insulin-ism that makes a pancreas produce mass amounts of insulin unpredictably.
A key for the two pens is that they'd cut the traditional glucagon process down from nine steps to only three! You would just remove the cap, place the pen onto the skin, and push the button.
We caught up with Xeris CEO Doug Baum recently to talk about their progress, and what we PWDs can realistically expect regarding getting these glucagon pen and pump-compatible varieties into our hands.
"We're the only soluble glucagon in clinical testing right now," Baum told us. "There are others who are trying to do the soluable programs and others that are taking dry powder mixtures and reducing those steps, but it's still not as simple as what we are doing."
Baum says Xeris finished its Phase 2 trials for the G-Pen last fall, at the Texas Diabetes Institute in San Antonio under the direction of Dr. Ralph DeFronzo. The trials showed that at room temperature, the Xeris glucagon has "rock-solid stability" over 18 months and is 92% pure at the 18-month mark, making it comparable to the Lilly glucagon product currently on the market. The company's still doing more detailed data analyses, but Baum says that top line data shows that Xeris glucagon is considered "bio-equalivent" to what Lilly produces.
A shorter Phase 3 trial is planned for later this year, and manufacturing and commercial programs are being prepared for kick off, prior to the company's New Drug Application (NDA) submission with the FDA that will likely happen in 2015 (just about the same timeline as Biodel's planned regulatory review).
Since Xeris' NDA will be eligible for the FDA's fast-track program, Baum said he expects their regulatory review process to be shortened from 12 months to only 6 months, and that could mean a market-ready product sometime in 2015.
Meanwhile, the G-Pen Mini is also going through trials at the Baylor College of Medicine in Houston, under the direction of Dr. Morey Haymond, who wrote a landmark scientific paper on the mini-dosing algorithm for treating moderate hypoglycemia in children with diabetes. They hope to start studies that include dosing human patients in late February or early March, Baum says.
Aside from the pens, Baum said Xeris is very excited about starting clinical trials for its pumpable glucagon soon at Oregon Health Science University, where an artificial pancreas trial is being by Dr. Jessica Castle (and formerly her colleague, Dr. Ken Ward).
** Update - April 24, 2014: Xeris announced that the first type 1 adult received a dose of the investigational G-Pump stable glucagon solution, delivered through an OmniPod as part of a Phase 2 clinical study.
That Oregon study coincides with what Dr. Steven Russell and Ed Damiano are doing on the Bionic Pancreas Project out of Boston, as Russell just recently filed an investigatory-use request with the FDA to use the Xeris G-Pump Glucagon in their studies using the Tandem t:slim pump.
"Our story is one of hope for people with diabetes, so that in the next two or three years they have an answer to hypoglycemia that is so dangerous," Baum said.
Yes, it would be really nice to have a better option if and when severe hypos hit -- doing away with the confusing glucagon instructions that surely traumatize the poor folks trying to help us.
Hopefully, we don't have to wait too much longer for this to materialize. We're crossing our fingers for Xeris.