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Wednesday, May 10, 2017

Sage highlights ‘signal of activity’ in Parkinson’s data, but questions linger

By  Ben Adams
May 10, 2017

Sage Therapeutics posted phase 2 results from its Parkinson’s disease study yesterday in which it said its experimental med could help tremors, but the top-line data were met with confusion by Bio Twitter, and its shares fell more than 3% in normal hours trading.

The data, released alongside its financials, showed lightly detailed results from its “exploratory” Part A open-label portion of a small, 12-person phase 2 test for SAGE-217 in Parkinson’s.

The dozen patients with a moderate form of the disease were all on stable doses of the antiparkinson agent levodopa/carbidopa prior to the study, with patients withdrawn from maintenance therapy and given a morning dose only of levodopa/carbidopa for three days, followed by a single morning dose of SAGE-217 on its own for four days.

For the overall population in the trial, levodopa/carbidopa activity was primarily focused on the motor symptoms of bradykinesia and rigidity, while SAGE-217 activity as a monotherapy was primarily focused on tremor symptoms.

In the five subjects with overt tremor (tremor score over 5 at baseline), 20% to 30% saw an improvement in tremor symptoms during the four days of SAGE-217 open-label treatment, the biotech said.

“This improvement in tremor score during the SAGE-217 dosing phase was longer-lasting than the effect on tremor observed in these subjects during the levodopa/carbidopa-only phase,” it added.  

The test was set up to see whether it was worth continuing on with further trials, and the company said it saw enough hints of activity to proceed on to an open-label Part B, which will be designed as an adjunctive treatment to antiparkinson agents in tremor-predominant patients. It also plans to assess nonmotor symptoms of Parkinson’s disease, including depression, anxiety, cognition and sleep.

But Sage's shares dropped yesterday, with some questioning just how positive these results were. Alfredo Fontanini, M.D., Ph.D, associate professor of neurobiology and behavior at Stony Brook University, tweeted: “Ok my first reading of $SAGE results on PD ... unclear signal; 20-30% reduction of UPDRS tremor in subset of patients, not too strong.”

TheStreet columnist Adam Feuerstein added: “$SAGE says ‘217 showed enough 'signal of activity' in Parkinson’s to move forward. Reading data, I have no idea if that’s bullshit or not.”

A few months back, Sage fueled, then dampened, its own M&A rumors after CEO Jeff Jonas was quoted as saying his company was at the top of everyone’s buying list, sending its shares jumping. But a few short hours later (and just before the end of after-hours trading), the chief rowed back on the M&A talk. This came after the biotech posted positive data for SAGE-217 in a small, phase 2 test, that time in major depressive disorder.

On a call with investors yesterday, Jonas said of the Parkinson’s data: “Please recall that this is an open-label trial, designed primarily to help with designing methodology and determining how SAGE-217 might fit into the Parkinson’s disease armamentarium. These initial results, they are open label need to interpret cautiously.

“Overall, the study suggested that as a great monotherapy, given at lower doses in the morning during a short duration of therapy, SAGE-217 did not have an impact on certain Parkinson's disease symptoms in general but did have an impact in reducing tremor.”

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