By Mary Welch

Inhale Therapeutic Systems Inc.'s pulmonary-delivered insulin successfully went head-to-head with injection delivery in a Phase IIb trial and is now expected to move into a Phase III study by year's end.

Both Inhale and Aradigm Corp. this week released promising data on devices that deliver insulin to the body without using a needle. The findings were reported at the American Diabetes Association's Scientific Session, in Chicago.

San Carlos, Calif.-based Inhale, along with partner Pfizer Inc., of New York, produced results of a three-month Phase IIb trial with 121 outpatients that showed inhaling insulin and taking it by injection resulted in similar blood glucose control and dose-to-dose reproducibility numbers. Moreover, patients significantly preferred inhaling to injecting.

Phase III trials should start in November with 1,000 persons. Pfizer is conducting the trials and will market the product if it is approved.

"Studies show that people don't take as much insulin as they should because they don't like giving themselves shots," said Robert Chess, president and CEO of Inhale. "By inhaling, it not only provides a more convenient way of taking insulin, but we feel that more people will take all their prescribed insulin. And people who don't take any insulin, but should, would take it if they could inhale it, according to our research."

If more diabetics took insulin, complications from the disease -- which include blindness, kidney failure, heart disease and stroke --would likely be reduced. "The total cost of diabetes, including treatments and lost productivity, is $92 billion a year. That's five times the total costs of HIV, AIDS and breast cancer combined," he said.

Inhale's product, about the size of a flashlight, disperses a dose of dry-powder insulin into a small standing cloud within a clear chamber. It delivers the dose through the mouth and directly into the lungs, where it enters the blood system as a rapid-acting insulin.

Most Patients Still Using Inhaler After Studies

One study focused on patients with Type I diabetes. Type I diabetics have an autoimmune disorder in which the body destroys the insulin-producing beta cells in the pancreas. These patients require daily insulin, often more than once.

Seventy subjects were given inhaled treatments or injections for three months. The injected group continued on their prior regime of two or three injections daily, while the inhaled group took one or two inhalations of insulin per meal. Both received a slow-acting insulin injection at bedtime.

In the second test, 51 patients with advanced Type II diabetes were given injections or inhalation treatments, again for three months. The patterns of use and study goals were the same as with the first group. Type II diabetes occurs when the body fails to use insulin properly.

In both tests, researchers found improvements in blood glucose and the changes of glycemic control (Hemoglobin Alc) were nearly identical. Glycemic control is the standard measurement of how well the diabetes is in check -- in other words how well the insulin is processing sugar after a meal, Chess said.

In addition, 80 percent of those in the Type I study and 92 percent in the Type II study preferred the inhaler and have continued using it after the trials. "In 18 months, we've given about 100,000 doses out and it's working as well as the injections, and the patients like using the product," Chess said.

Also chasing the inhaled insulin market is Aradigm of Hayward, Calif., which released Phase I results at the Chicago conference.

Aradigm's delivery system, the AERx Pulmonary Drug Delivery System, allows insulin to be more quickly absorbed from the lung and reduces blood glucose faster than traditional injections, the company reported. In addition, it said that unlike injected insulin, higher concentrations of inhaled insulin could be given without delaying the reduction in blood glucose.

Aradigm's system provides the insulin in small liquid tablets that are inserted into the electronic inhaler. The patient takes a deep breath and when a green light comes on (signaling that the patient is breathing slowly and properly), the device quickly fires the dosage through the inhaler and releases it into the mouth as an aerosol.

"This system is reliable and delivers the insulin in the proper dosage deep into the lungs where it instantly enters the blood system," Aradigm's president, Richard Thompson, told BioWorld Today earlier this month. Novo Nordisk A/S of Bagsvaerd, Denmark, in a $50 million deal consummated this month, will jointly develop and system. (See BioWorld Today, June 4, 1998, p. 1.)

AERx should be in Phase II trials by year's end.

"There are differences between the two products, " Chess said. "One thing, our product is years ahead of theirs in development. The second is that ours is a dry powder, which is not sensitive to heat or cold. With liquid insulin, you can't take it out in heat above 86 degrees or in extreme cold."

"Convenience is key," he added.

Inhale's stock (NASDAQ:INHL) closed Wednesday at $31.25, up $3.50. Aradigm's stock (NASDAQ:ARDM) closed Wednesday at $14, down $0.125. *

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