By Mark Terry, BioSpace.com Breaking News Staff
Cambridge, Mass.-based Sage Therapeutics announced yesterday a new and accelerated timeline for its Phase III STATUS Trial for SAGE-547 to treat super-refractory status epilepticus (SRSE), a severe seizure disorder.
Prior to this announcement, Sage did not expect results from this trial until 2017, but enrollment has gone quicker than expected, and as a result, Sage has moved up its timeline. SRSE is a life-threatening seizure disorder so severe that patients are typically placed into a medically-induced coma. The drug gives researchers and patients hope that this therapy will allow the patients to be revived.
The company has also announced updates on various other clinical programs. “2016 will be an important and milestone-rich year for SAGE,” said Jeff Jonas, Sage’s chief executive officer, in a statement. “In the first half of 2016, we expect data readouts from our placebo-controlled Phase II trial of Sage-547 in severe postpartum depression and from the Sage-217 Phase I clinical program.”
In June 2015, Sage announced dramatic top-line data from its SAGE-547 trial in postpartum depression (PPD). It was a tiny study based on only four women with PPD. Before treatment, they were evaluated using the Hamilton Rating Scale for Depression (HAM-D). The patients’ baseline score was 26.5. A HAM-D rating of 24.0 or greater is considered severe depression. A score below 7.0 is called symptom-free. Within 60 hours of receiving SAGE-547, all four women showed a HAM-D score of 1.8.
Jonas went on to update other pipeline programs, saying, “In the second half of the year, in addition to the SAGE-547 Phase III data, we expect to launch multiple Phase II trials evaluating SAGE-217 in essential tremor, orphan epilepsies and potentially postpartum depression, assuming successful replication of earlier stage work. We also expect to initiate the SAGE-689 Phase I development program in the second half of 2016. Along with these clinical milestones, SAGE is also committed to continuing its groundbreaking work studying the NMDA neurotransmitter system and its impact on CNS diseases, and we plan to present additional scientific data on this work in 2016.”
SAGE-547 is given intravenously. It is an allosteric modulator of GABAA receptors, both synaptic and extra-synaptic. There are an estimated 25,000 SRSE cases diagnosed each in year in the U.S.
It’s been a bumpy year for SAGE . Shares traded on Feb. 6 for $36.99, rose to $57.85 on May 4, and spiked to a year-high of $86.71 on June 9. Shares then started a fairly consistent fall to $43.04 on Sept. 28. They have been recovering since, currently trading for $56.10.
Eight analysts provided a consensus of “buy,” according to Storm Investor. Seven gave the company a “buy” rating and one gave it a “strong buy” rating. The average one-year price target in the last year is $87.92. William Blair gave SAGE a “buy” rating on Sept. 4. Leerink Swann issued a “buy” rating on Sept. 3. JPMorgan Chase & Co. reiterated an “overweight” rating on Sept. 3.
In a filing with the Securities & Exchange Commission (SEC), company insider Stephen Kanes sold 6,000 shares of Sage stock on Monday, Sept. 28 for an average price of $46.42, a total of $278,520.
