By Matthew Willett
Immunex Corp. stopped Phase II/III trials of Enbrel in chronic heart failure when an independent data monitoring board told the company it is not likely that the therapeutic would meet the efficacy endpoints.
But in separate news released after the market closed Thursday, Immunex said another Enbrel trial, this one a Phase III in psoriatic arthritis, produced positive data. And other data, however, indicated that the company's Nuvance didn't meet efficacy endpoints in two Phase II studies in asthma patients not using steroid therapy. A third study in patients on steroids is ongoing.
Immunex Chief Operating Officer Peggy Phillips told BioWorld Today just prior to a conference call on the news that companies "live and die by data," but that the reality is less discouraging than it might seem.
"We were looking at this quarter as a quarter when we'd see lots of data and learn a lot about how to move forward with different opportunities, and we've been able to show with data we released today that Enbrel has another market to expand to, psoriatic arthritis," Phillips said. "That's about 250,000 people this can benefit, and we'll move quickly to file that with the FDA in about the middle of this year."
Enbrel was first approved in November 1998 to treat moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more disease-modifying anti-rheumatic drugs. (See BioWorld Today, Nov. 3, 1998.)
Enbrel also gained an approval in May 1999 to treat children and teen-agers with moderately to severely active polyarticular-course juvenile RA. Enbrel gained further expanded approval for treatment of early stage RA last year. (See BioWorld Today, June 8, 2000, and June 1, 1999.)
Phillips added that Immunex will seek fast-track status for the expanded indication in psoriatic arthritis. Other news wasn't so positive, but Phillips viewed the results in light of the low likelihood of clinical trial successes.
"We also received information from some other products, and we're putting it in context of looking at how many clinical trials are successful in this industry and why drug discovery is so costly as we move forward." she said. "We had, for Enbrel, a trial looking at potential benefit in chronic heart failure, and we're stopping that study based on a lack of efficacy. An independent data monitoring board's assessment was that there was a lack of benefit, and therefore we should not continue with the study.
"Finally, with our product Nuvance, we were looking at the population in asthma of patients on beta agonists who were not ready to go to steroid treatment," she said. "We were looking at the ability of the drug to open up airways and bring lung function to normal in two studies and in that population results were negative. In a third study in people where lung function has been stabilized by steroid therapy we were looking at tapering off in steroids and seeing if lung function could continue at the level it had been stabilized at with steroids, and we'll see those results in the third quarter."
The silver lining, Phillips maintained, is in the allocation of resources.
"Nothing has changed in the fundamentals of Immunex. As far as how we're looking and moving forward, nothing is different from the rest of the year and what we've planned," she said. "We're looking at opportunities to invest in different programs in different indications in the pipeline. One thing the clinical data we reported today does is help us learn from these indications and move forward in other indications with these products, just in different diseases.
"We live and die by data," she said. "When we get data we respond to it, and it allows us to be decisive and manage resources and focus on opportunities where we're able to deliver promise to patients, in whatever disease state. You put your heart and soul into any clinical trial, and as you move into it you sometimes learn that the design of the trial or the indication wasn't exactly the best, but you continue to move forward, looking for other opportunities, and you learn from these trials and apply that knowledge as you look at other opportunities in the pipeline."