FDA, Regulatory

With a big assist from the FDA, Sage plots a swift march through PhIII for oral depression drug — market cap swells $1B-plus

The FDA is putting Sage Therapeutics’ oral depression drug SAGE-217 on their inside track, blessing a fast-paced late-stage strategy that includes designating their ongoing study for post-partum depression a pivotal effort.

Jeff Jonas

According to Sage execs $SAGE, regulators will demand only one more late-stage study, which will now get underway in a matter of months. Sage plans to evaluate “two weeks of 20mg or 30mg SAGE-217 treatment compared to placebo in 450 patients with MDD, with four weeks of additional follow-up.”

Researchers will continue to follow hundreds of patients for up to a year to better consider the drug’s safety and how to handle the recurrence of major depression.

Sage is going after episodic cases of depression after noting in its most recent round of data that the drug’s effect dropped off in the 4- to 6-week stretch, losing its impact with patients as remission rates tailed off into insignificance.

The news sounded upbeat to investors, driving shares up about 6% in pre-market trading, then surging to an 18% gain by early afternoon. Sage started the day with a whopping $6.8 billion market cap which has now swelled past the $8 billion mark.

The agency is signing off on a plan that offers a dramatic shift from the usual long and drawn out late-stage testing of depression drugs in big, multiple studies — making it one of the most difficult fields in R&D plagued by high placebo responses. The biotech is going after a new mechanism — extra-synaptic GABA-modulation — while the current generation of drugs share common neurotransmitter targets like serotonin, dopamine and norepinephrine.

The current therapies are problematic at best, with patients often cycling through multiple meds in search of one that can work, for awhile.

Scott Gottlieb

The accelerated late-stage program underscores the new management that’s now at the FDA. Scott Gottlieb promised to accelerate development under his tenure as commissioner, and this opening for Sage is a clear indication of his willingness to champion speed over caution. Other biotechs are likely to pay very close attention to what’s happening here, looking to mimic Sage’s rapid forward movement.

The move comes soon after regulators gave Sage’s infused depression drug brexanolone a priority review, lopping months off the process and possibly heralding the biotech’s first commercial launch — if everything goes according to plan.

As always, CEO Jeff Jonas is all in touting their drug as a game changer. He said:

In this development program, we are 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. We believe a medicine with rapid onset and robust response could be truly paradigm shifting. 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.


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