Biopharma is finally improving depression treatment outcomes and providing more options to patients

On Tuesday April 16, psychiatry specialists, and Arctic Aurora LifeScience and Arctic Aurora Biotech Select holding, Intra-Cellular Therapies rallied nearly 25% on positive Phase 3 clinical trial depression results. The news adds to the list of good news in the treatment landscape for Major Depressive Disorder or MDD, colloquially known as depression.

The debilitating symptoms of depression like the feeling of sadness, hopelessness and helplessness along with suicidal ideation are well known to the public. Some might also know that according estimates, 280 million people suffer from this condition globally. What is less known however, is that two-thirds of these patients fail to achieve an improvement when they take medicine for the first time. Therefore, people with depression are still in a need for improved treatment options.

With the recent news, Intra-Cellular took a step towards providing such a treatment option for depression patients. The psychiatry specialist company published positive results from their Phase 3 study, where one group received the company’s drug lumateperone together with an approved antidepressant, while the comparator group received placebo and an antidepressant. Lumateperone led to rapid improvement in multiple depression symptom scores versus the comparator arm and did that with a benign side effect profile. These results further strengthen the profile of lumateperone, which is already approved in schizophrenia and bipolar depression under the brand name Caplyta. The medicine generated USD 462 million sales in 2023, which represented an impressive year-over-year growth of 86%. The news prompted a 23.3% market value rise for Intra-Cellular on the day.

The news adds to the approval of Johnson & Johnson’s antidepressant Spravato in 2019 in treatment resistant depression and Axsome Therapeutics’ Auvelity in 2022. While vastly different mechanisms of action, those new drug are signified by their quick onset of effect. Something that differentiates them from traditional antidepressants that take some time before positive effects become apparent and that is also associated with side effects such as sleep issues, reduced sexual drive or function and commonly, while feelings of depression eases so does also all other emotions, including positive ones. This side effect is commonly known as blunting and does not appear to the same extend with the novel medical treatments. As shown by Spravato and Auvelity, in the latest Intra-Cellular study, the new agent also start to work quickly with a change often seen already after one week of treatment and subsequently Intra-Cellular reported a statistically significant effect after 6 weeks of treatment.

With the development progress and introduction of new medicines there is hope for improved management of depression going forward. This is particularly important as the disorder appears to be on the rise in developed countries, particularly among adolescents and young adults and the economic burden of depression in the US alone is estimated to be well over USD 350 billion per year.