A number of companies are in the race to develop stable formulations of glucagon that would replace the multistep, syringe-and-vial approach to treating hypoglycemic episodes in diabetics. One of them that’s developed a low-volume formulation that’s stored in a two-step injectable glucagon pen is preparing for phase 2 clinical trials and looking for financing.
Xeris Pharmaceuticals’ platform technology takes biopharmaceuticals that must traditionally be dissolved in water and delivered by large volume, and reformulates them into low-volume, pre-mixed pastes or liquids that are stable at room temperature, portable and stored in an existing self-injection device.
The company’s first product, the G-pen, is a stable formulation of glucagon that has a two-year shelf life. “We’ve also reduced the injection volume by 80 percent when compared to the water-based formulations, which makes the injection less painful and faster,” said CEO John Kinzell.
A phase 2 clinical trial with the School of Medicine at The University of Texas Health Science Center San Antonio and the Texas Diabetes Institute of the University Health System in San Antonio will start in August, and according to a memorandum on the company’s website, it’s anticipating a late 2013 new drug application filing (PDF). A lower dose of the formulation, to allow patients to correct low blood sugar without eating, would be a follow-on product.
The G-Pen sounds a lot like Enject’s much-anticipated GlucaPen, which isn’t exactly a bad thing given the hype it’s received in the diabetes community. And, if Xeris can succeed in its future plans to develop a pump-friendly formula, it could become part of the hailed artificial pancreas. Other companies developing glucagon products include Biodel and LATITUDE.
Further down the line, Xeris thinks its platform also has potential for use with other peptides and proteins, monoclonal antibodies, and vaccines, according to its website. Other products currently in development include a nonaqueous diazepam formulation to treat epilepsy and a nonaqueous formulation of an approved therapeutic for multiple sclerosis.
Formed in 2005 in San Francisco, the company is now based in Austin, Texas.
As for NMP. It causes birth defects. See: http://en.wikipedia.org/wiki/Methylpyrrolidone http://www.cdph.ca.gov/programs/hesis/Documents/nmp.pdf
According to the poster, they are using DMSO and NMP as solvents. DMSO is approved by FDAfor a single non-systemic use as an active, and is NOT approved as an excipient. This approach will require extensive safety testing, and has additional downsides - See: http://www.dmso.org/articles/information/muir.htm http://en.wikipedia.org/wiki/Dimethyl_sulfoxide