Sage Therapeutics has announced a potential fast path to approval for an experimental depression drug—as well as plans to treat patients with it for just two weeks until they feel relief, not chronically as with other treatments for the disease.
After meeting with the FDA, Cambridge, MA-based Sage (NASDAQ: SAGE) said it will only have to run one 450-patient Phase 3, placebo-controlled trial of experimental SAGE-217 in major depressive disorder (MDD), not two, to win FDA approval. An ongoing study of 140 patients with SAGE-217 in postpartum depression is also now deemed a “pivotal” study, meaning if both trials are successful—no guarantee, given the litany of psychiatric drugs to fall short in Phase 3 tests—Sage could win FDA approval of SAGE-217 for both types of depression. The company has already run a randomized, placebo-controlled Phase 2 study for MDD in 89 patients.
The FDA has become increasingly flexible over the past several years, using various designations meant to streamline drug approvals. With SAGE-217, for instance, Sage is benefiting from the FDA’s “breakthrough therapy” designation, one of the regulatory tools used to speed approvals. One of the benefits is “intensive guidance on an efficient drug development program,” according to the FDA’s website.
An estimated 16 million Americans suffer from MDD, and while marketed antidepressants are effective for some, they typically don’t kick in for a few weeks. Many patients don’t respond to treatment at all, but when they do, they often take these drugs chronically.
Sage said this morning, however, that both its MDD and PPD studies will test a two-week course of treatment of SAGE-217 and see if it can curb depression symptoms quickly, compared to a placebo. In a statement, Sage CEO Jeff Jonas (pictured) said the company is exploring “the potential for patients with MDD to feel well within days, with just a 2-week course of treatment—similar to how antibiotics are used today—instead of enduring long-term chronic treatment.”
In Phase 2 testing, patients on SAGE-217 saw their scores on a measure of depression symptoms known as the HAM-D scale fall an average of 17.6 points after 15 days, compared to an average 10.7-point reduction in scores for placebo patients. Patients on SAGE-217 and placebo started the study with average HAM-D scores of 25.2 and 25.7, respectively. After 15 days, 64 percent of patients on the Sage drug had a HAM-D score of 7 or less—a secondary goal of the study—compared to 23 percent of placebo patients.
“We believe a medicine with rapid onset and robust response could be truly paradigm shifting,” Jonas said in the statement. “SAGE-217, if successfully developed and approved, may rewrite the textbook on how the tens of millions of people suffering from MDD are treated, ultimately turning depression into a disorder, not an identity.”
SAGE-217 is a once-daily pill that targets a neurotransmitter called GABA. In addition to MDD and PPD, Sage is evaluating the drug as a treatment for Parkinson’s disease and essential tremor. The company could win FDA approval of its first drug, a infusible treatment called brexanolone, for PPD, by late December.
Sage is holding a conference call this morning to discuss its plans.