Drugs, Sage Therapeutics and Biogen: Coral study goals on zuranolone achieved

Sage Therapeutics and Biogen announced that “the Coral study, carried out on patients with major depressive disorder (MD), achieved its goals, demonstrating a rapid and statistically significant reduction in depressive symptoms on day 3 and over the course of two weeks of treatment. , reaching the primary and main secondary endpoints. This evidence was demonstrated at the first control – explain the companies in a note – which took place on day 3 from the beginning of the administration of zuranolone 50 mg in combination with a tricyclic antidepressant drug (Adt), and ascertained through the detection of a change from baseline in the Hamilton depression rating scale (Hamd-17) “. The Coral study also “met the primary secondary endpoint: zuranolone 50 mg, given in combination with a standard antidepressant drug, showed a statistically significant improvement in depressive symptoms, when compared to the administration of a standard antidepressant drug combined with placebo. over a two-week treatment period. Zuranolone 50 mg was generally well tolerated and no adverse events were identified that warrant further investigation, “the companies continue. The Coral Study “achieved its goals by highlighting the potential of zuranolone, administered in conjunction with standard therapy, in accelerating patient benefits with this treatment compared to treatment with antidepressant drugs alone.” Coral is a clinical study that “compared the combination of zuranolone 50 mg with a standard antidepressant drug (active control drug Adt) with that of a standard antidepressant drug given in combination with placebo in people with MD, who did not know whether they would have received the drug or placebo. At day 3, the clinical trial demonstrated a mean change from baseline in Hamd-17 total score of -8.9 ± 0.39 (n = 210) in subjects treated with zunarolone and Adt, compared with a change of -7.0 ± 0.38 (n = 215) in subjects treated with placebo and Adt. The primary secondary endpoint measured the effect of therapy over the 2-week treatment course in all scheduled visits (using equal weighted means for days 3, 8, 12, and 15). The change in mean over the treatment period in subjects who received zuranolone with an Adt was -11.7 ± 0.40 (n = 210) compared to -10.1 ± 0.39 (n = 215) in those who received placebo-associated Adt. ” Other secondary endpoints, explain Sage Therapeutics and Biogen, “demonstrated a statistically significant reduction in Hamd-17 score with zuranolone combined with Adt, compared to placebo with Adt, at days 8 and 12. An increase was recorded at day 15 and at day 42 an equivalence. Based on consistent results suggesting a benefit of zuranolone in people with HD with high anxiety in the Landscape program, the Coral study prospectively examined this population. In the Coral Study subgroup (n = 218 of 425 people , 51.3%, with Ham-A total score ≥20 at baseline) zuranolone associated with Adt was nominally statistically significant compared to Adt with placebo in reducing depressive symptoms as measured by the primary endpoint (-9.3 versus -6 , 0; change in Hamd-17 total score from baseline) and major secondary endpoint (-11.7 versus -9.4; change in Hamd-17 total score from baseline) “. “The potential of zuranolone in responding to the unmet needs of this population, historically less reactive to Adt administered continuously, has been demonstrated”. “We believe the Coral study is clinically significant,” commented Barry Greene, Sage CEO. With the addition of these data, the Landscape program now demonstrates that zuranolone has three potential uses in patients for the treatment of MD. Landscape support the efficacy of zuranolone as a monotherapy. Since many subjects in previously completed studies were already taking maintenance Adt, we believe our data confirm that zuranolone can also be used as an add-on therapy. The Coral study further demonstrates the use of zuranolone to accelerate the benefit of conventional ADTs in the treatment of MD, with a well-tolerated safety profile. Taking the Coral study into account, zuranolone now has six positive clinical trials and we are well on our way to submitting an approval request for a new drug. for the treatment of MDD scheduled for the second half of 2022 “.” Le eviden Positive zs from the Coral study indicate that zuranolone taken with standard therapy may offer faster relief from depressive symptoms than single therapy. – said Priya Singhal, Md, Mph, Head of Global Safety and Regulatory Sciences and Interim Head of R&D at Biogen – Based on the results observed in the Clinical Development Program Landscape, we believe that zuranolone has the potential to offer a new treatment option. clinically significant for people with major depressive disorder. “” In the Coral study, zuranolone 50 mg taken with a standard ADT was generally well tolerated, the companies report, and no adverse events were identified that warrant further investigation. Most of the patients included in the study, treated with zuranalone, experienced adverse events of mild or moderate intensity, consistent with previous data from the Landscape program. Adverse effects, which occurred in 10% or more when zuranolone was administered with Adt, were somnolence (18.4%), dizziness (13.2%) and headache (11.8%). In the case of Adt with placebo, the adverse effects that occurred in 10% or more of the subjects were headache (14.7%) and nausea (23.4%). The safety data from the Coral study confirm the safety profile of zuranolone based on the clinical studies conducted to date. “” The results from the Coral study were particularly interesting because they showed that, over the course of a few days, zuranolone produced a rapid reduction in depressive symptoms compared to current ADTs, which in clinical practice can take weeks or months to function, “said Sagar Parikh, professor of clinical neuroscience and psychiatric sciences at the University of Michigan.” In my experience, people with MD are deserving to feel better as soon as possible, with treatment with tolerable side effects. These data suggest that zuranolone is able to offer this option and provide doctors with the opportunity to treat MD differently. ”The companies plan to present additional data from the Coral study in several scientific forums to be held in the future.