A new kind of “ultrafast” insulin developed by Halozyme Therapeutics, Inc., has been shown in two clinical trials to work just as well as other insulin replacements in patients with both Type 1 and Type 2 diabetes.
According to Halozyme, the new insulin—called PH20—was as effective as Humalog, an Eli Lilly and Company product, at controlling blood glucose levels. Halozyme stated that PH20 was actually more effective at controlling postprandial glucose levels, or blood sugar levels after a meal. Hypoglycemia rates in PH20 users were similar to those of Humalog users. The two studies were Phase 2, mid-stage clinical trials, each using data from about 110 participants.
One study was conducted on patients with Type 1 diabetes while the other studied participants with Type 2 diabetes. The studies compared effects of PH20 with those of Humalog. PH20 is an insulin analog—a type of insulin that is not produced biologically but synthetically, yet functions the same in the human body as the insulin produced by the beta cells of the pancreas.
PH20 is derived from rHuPH20 (Lispro-PH20 or Aspart-PH20), a recombinant human hyaluronidase enzyme, which “temporarily degrades hyaluronan, a structural protein in the interstitial space,” according to Halozyme. The enzyme allows the delivery of therapeutic medications through subcutaneous injections rather than intravenously. According to Halozyme, subcutaneous injection of pharmaceuticals provides a variety of benefits for patients, including increased convenience and efficiency, extended product life cycle, and decreased costs.
The patients using PH20 insulin demonstrated more than a 50 percent increase in the number of patients who were able to consistently achieve post-mealtime blood glucose targets that are established by the American Association of Clinical Endocrinologists. Patients using PH20 insulin did not demonstrate a significant increase in hypoglycemia or hypoglycemic events; the events that did occur were typically mild and were similar to those experienced by patients using Humalog.
Halozyme stated that it will be pursuing methods of making PH20 available around the world, which means that the company may form a partnership with a larger pharmaceutical manufacturer. Halozyme will present the complete findings of the two studies at a medical conference in 2012. The news boosted Halozyme’s market presence, with shares 49 cents to $8.21 in afternoon trading, a 6.3 percent increase.
Halozyme’s shares also jumped recently by 18.6 percent when the company announced successful clinical trials of a breast cancer drug that Halozyme is developing with Swiss pharmaceutical company Roche. The drug is a variation of Herceptin, which is normally administered with an IV; Halozyme and Roche are working on an injectable version, which was shown in the trial to be just as effective as the IV version. The injectable version will offer more convenience to patients as it can be administered in about five minutes, while the IV version takes about 30 minutes.
According to Halozyme, the company is “dedicated to the development and commercialization of products targeting the area outside the cell known as the extracellular matrix,” a system that provides structural support for tissues and is responsible for directing some important biological activities in humans, such as cell migration, signaling, and survival. The importance of the matrix in biochemical processes allows Halozyme to target the system for treating illnesses. The company was founded in 1998 in San Diego and primarily targets the endocrinology, oncology, dermatology, and drug delivery markets.