"This was a phase II trial in a patient population where heretofore there haven't been any trials of peripherally active kappa agonists – none. This was really our first tour in the water, and we wanted to discern, in a safe way, an appropriate dosing range for these patients to see efficacy in the first placebo-controlled trial we've run. So our main aim was, based on what we'd seen in the phase IIa, to take that similar dose range, extend the dosing duration and incorporate a design using self-titration that would allow patients to titrate to the most effective dose. That's a way we can use the empirical mean joint pain scores to discern the best tablet strengths for this particular group of patients."
Derek Chalmers, president and CEO, Cara Therapeutics Inc., on the phase IIb trial of the oral formulation of peripherally selective kappa opioid agonist CR-845 in patients with osteoarthritis of the knee or hip. The findings, despite a statistical miss vs. placebo across the study population, showed a "clear positive signal" warranting additional work
"The most current work that we're doing with Caltech and the DoD is to develop a high-throughput production version of our current manual process. That's an interesting project especially to our investors who believe that if we can systematize this process so you can make almost any body chemistry lab capable of this kind of work, you can address so many biological questions very quickly in ways that weren't addressable before. And so that's our goal."
Albert Luderer, CEO, Indi Molecular, which raised $11.5 million in a series A financing to help it advance into the clinic with PET immuno-oncology imaging
"This ruling sends an important signal that Canada is open for the business of innovation."
Patrick Kilbride, vice president of international intellectual property policy at the U.S. Chamber of Commerce's Global Intellectual Property Center, on the Supreme Court of Canada unanimous ruling that struck down the so-called Promise Doctrine, a judicial test lower courts have used to invalidate 26 patents covering 22 drugs over the past 12 years