Sage Therapeutics, Inc. SAGE and partner Biogen Inc (NASDAQ:BIIB). BIIB reported that the mid-stage study, KINETIC, on SAGE-324 for the treatment of people with essential tremor (ET) was successful.
SAGE-324 is an investigational oral neuroactive steroid (NAS) GABAA receptor positive allosteric modulator (PAM). KINETIC is a phase II study that evaluated the efficacy, safety and tolerability of SAGE-324 60 mg in 69 patients with ET, aged 18-80 years.
The study (n=67 full analysis set) achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale (TETRAS) Performance Subscale Item 4 upper limb tremor score at day 29.
SAGE-324 demonstrated a 36% reduction in upper limb tremor amplitude from baseline at day 29 in the total studied population. SAGE-324 demonstrated a 41% reduction in upper limb tremor amplitude compared to baseline in a more severe population.
Activities of daily living (ADL) scores showed a statistically significant correlation with upper limb tremor scores at all time points. SAGE-324 demonstrated a safety profile generally consistent with the previously reported data.
One of the most common movement disorders in the United States, ET, affects roughly 6.4 million people.
The companies are now evaluating the next steps for the development of SAGE-324. The strong correlation observed in this study between TETRAS performance scale – measuring the reduction in upper limb tremor, a disabling symptom experienced by more than 90% of people suffering from ET — and improvement on the ADL score reinforces the efficacy of the candidate for treating this population.
Sage’s stock has lost 17.7% in the year so far compared with the industry's decline of 11.6%.
Sage and Biogen collaborated in December 2020 to jointly commercialize products containing zuranolone and those containing SAGE-324 in the United States. We remind investors that Sage’s first product, Zulresso brexanolone) CIV injection, is approved in the United States for the treatment of postpartum depression in adults.
Sage currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech sector include Repligen (NASDAQ:RGEN) RGEN and Moderna (NASDAQ:MRNA), Inc. MRNA. While Repligen sports a Zacks Rank #1 (Strong Buy), Moderna carries a Zacks Rank #2 (Buy), at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Repligen’s earnings estimates for 2021 have increased to $1.91 from $1.66 in the past 60 days.
Moderna’s earnings estimates for 2021 have increased to $22.72 from $21.58 in the past 30 days.
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