Pearl Therapeutics put its combo LAMA/LABA treatment for COPD--PT003--up against two standard treatments for the lung disease and says it emerged with a commanding lead based on a key method for scoring the data. After announcing top-line results near the end of last year, the biotech company today detailed just how much better PT003 did as it grooms itself for a much-needed collaboration pact and positions itself against Big Pharma teams now racing ahead with late-stage blockbuster hopefuls.
"Treatment with PT003 resulted in a statistically significant improvement in" the measure of air beathed out by a patient "of 47% (or 93 mL) over Foradil and 49% (or 95 mL) over Spiriva after one week of dosing," the company reported. The data "demonstrate an overwhelmingly superior outcome and an even larger degree of bronchodilation than our internal benchmark of 70 mL, providing what we believe to be a clinically meaningful benefit," noted Chief Medical Officer Colin Reisner.
"There is a very rapid onset of action, high peak effect," Sarvajna Dwivedi, Pearl's executive vice president of R&D, tells FierceBiotech. "Patients will feel an improvement in their lung function and that translates to a symptomatic benefit."
One of the difficulties that Pearl faces, though, is that Novartis is already racing to the market with a pair of COPD treatments that it is studying as a follow-up combo product with mega-blockbuster potential--QVA149. And Pearl notes that GlaxoSmithKline is also racing ahead with its own Phase III program for a once-daily LAMA/LABA treatment, a program partnered with Theravance. But Pearl says it doesn't have to be the first developer to hit the FDA's finish line.
"We don't have to be the first one on the market," says Chuck Bramlage, the newly named CEO. "I know this market and we believe whether you're first, second or third, it doesn't matter. We believe this particular combination of products is going to be very helpful for patients."
One of Bramlage's top priorities now is striking a marketing deal on the program. Three more Phase IIb studies on the treatment just got underway to define the dose that will be used in Phase III. And even after raising $69 million in its last venture round, Bramlage says that research in this field is pricey. The CEO is now looking to strike either a global deal or regional ones to help pay for its pivotal late-stage study.
- here's the Pearl release
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