Neumora Therapeutics Announces Initiation of Phase 2 Study of Navacaprant in Bipolar Depression
Neumora Therapeutics has initiated a Phase 2 clinical trial for navacaprant, targeting bipolar depression. The company aims to evaluate the safety and efficacy of the 80 mg oral KOR antagonist, which previously showed promise in treating major depressive disorder (MDD). The trial will involve 60 patients and focus on improvements in depressive symptoms and anhedonia, with results expected in the second half of 2025. Additionally, navacaprant is in Phase 3 development for MDD, with data from the KOASTAL-1 study anticipated in Q4 2024. This study could lead to broader applications for navacaprant in bipolar disorder.
- Initiation of a Phase 2 trial for navacaprant aims to address unmet needs in bipolar depression.
- Navacaprant previously showed efficacy in treating depressive symptoms and anhedonia in MDD.
- The study involves a randomized, double-blind, placebo-controlled design, enhancing reliability.
- Results from the Phase 2 study are expected in the second half of 2025, providing a clear timeline for investors.
- Navacaprant is also in Phase 3 for MDD, showcasing its broad potential.
- The company has a pipeline of seven clinical and pre-clinical brain disease programs, indicating robust research and development activity.
- Topline data from the Phase 2 study will not be available until the second half of 2025, indicating a lengthy wait for investors.
- The success of navacaprant in bipolar depression is still unproven, posing a risk to shareholders.
- Ongoing development in multiple phases could result in high operational costs and financial strain.
- The trial only involves 60 patients, which may limit the generalizability of the results.
- Potential delays or negative outcomes in the KOASTAL-1 Phase 3 study for MDD could negatively impact stock performance.
Insights
Neumora Therapeutics' announcement of initiating a Phase 2 study for navacaprant in bipolar depression marks a significant step in the company's development pipeline. For investors, it's essential to understand that navacaprant employs a novel mechanism targeting kappa opioid receptors (KORs), which differentiate it from traditional antidepressants. This unique approach is potentially groundbreaking since KOR antagonism is believed to address anhedonia—a symptom often resistant to current therapies.
One should note that positive results from past Phase 2 studies in major depressive disorder (MDD) provide a solid foundation to anticipate similar outcomes in bipolar depression. However, the true measure of navacaprant's efficacy will be seen in the improvement of the Montgomery–Åsberg Depression Rating Scale (MADRS) scores, the primary endpoint. Given the complexity and high unmet need in bipolar depression, successful results could significantly enhance Neumora's market position and pipeline value.
From a market perspective, Neumora Therapeutics' advancement into Phase 2 of navacaprant for bipolar depression could signal substantial growth if the trial succeeds. The bipolar depression treatment market is characterized by limited effective options, leading to a high demand for innovative treatments. This trial's unique focus on KOR antagonism gives Neumora a potential edge.
Investors should consider the broader implications. Should navacaprant demonstrate efficacy, Neumora could capture a significant share of the market, given the lack of effective treatments. Additionally, the parallel Phase 3 study for MDD further strengthens their portfolio, indicating potential for cross-indication efficacy. However, the market should be cautious of the usual risks associated with clinical trials, such as potential safety issues or lack of efficacy, which could negatively impact the stock.
Potential to alleviate unmet need associated with depressed mood and anhedonia in bipolar depression; navacaprant has demonstrated the ability to improve these symptoms in MDD in a Phase 2 study
Navacaprant is also currently in Phase 3 development for the treatment of MDD with data from KOASTAL-1 anticipated in the fourth quarter of 2024
WATERTOWN, Mass., May 14, 2024 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven clinical and pre-clinical brain disease programs, today announced the initiation of a Phase 2 study evaluating the safety and efficacy of navacaprant in people with bipolar depression. Navacaprant is an oral 80 mg once-daily best-in-class kappa opioid receptor (KOR) antagonist, a novel mechanism of action in development for the treatment of major depressive disorder (MDD) and bipolar depression.
“Navacaprant’s novel mechanism of action has the potential for broad benefit across multiple neuropsychiatric disorders, and there is a strong rationale to evaluate its efficacy in bipolar depression. A growing body of research has characterized the pathophysiologic underpinnings of anhedonia in bipolar depression, a key feature that often remains unaddressed by standard of care. Given that in Phase 2 navacaprant demonstrated the ability to meaningfully improve depressed mood and anhedonia in other populations, we believe it may also be effective in treating these symptoms in bipolar depression,” said Robert Lenz, M.D. Ph.D., executive vice president and head of research and development, Neumora. “This is important because people with bipolar depression experience significant unmet need due to the atypical symptomology and resistance to current treatment options they often experience.”
“It’s clear that there’s an urgent unmet need for new approaches in the treatment of bipolar depression. With the current treatment paradigm, patients often cycle through multiple lines of therapy that do not sufficiently treat depressive symptoms, resulting in significant negative impact on patients’ quality of life and ability to function,” said Dan Iosifescu, M.D., Professor, Department of Psychiatry at NYU Grossman School of Medicine. “With this unmet need in mind, it is encouraging to see new mechanisms in development to address depressive symptoms in bipolar disorder that are supported by biological rationale. In fact, research suggests that KOR antagonism can play an important role in improving depressed mood and anhedonia – a hypothesis that has been reinforced by positive results from multiple clinical studies.”
The randomized, double-blind, placebo-controlled, Phase 2 clinical trial is designed to evaluate the safety and efficacy of navacaprant in people with depression associated with bipolar II disorder. The study will evaluate navacaprant 80 mg monotherapy in approximately 60 patients with a moderate-to-severe major depressive episode (Montgomery–Åsberg Depression Rating Scale (MADRS) ≥ 25). The primary endpoint of the study is change in MADRS at Week 6, and key secondary endpoints will evaluate the impact of navacaprant on anhedonia as well as other measures. Neumora expects to report topline data from this Phase 2 study in the second half of 2025. Results from this proof-of-concept study will inform further development of navacaprant in bipolar disorder, potentially including development in broader bipolar disorder populations.
About Navacaprant
Navacaprant (NMRA-140) is a highly selective, novel, best-in-class kappa opioid receptor (KOR) antagonist being developed as a potential monotherapy treatment for major depressive disorder (MDD) and bipolar depression. Navacaprant is an investigational once-daily oral 80 mg medication that is designed to modulate the dopamine and reward processing pathways, which play an important role in the regulation of mood, cognition, reward, and behavior. The KOR system is a well-characterized pathway known to mediate depressive-like states, and modulating this system represents a novel approach to treating MDD, bipolar depression, and other major neuropsychiatric disorders.
About Bipolar Disorder
Bipolar disorder may cause extreme shifts in a person’s mood, energy and activity levels. Bipolar and related disorders include bipolar I, bipolar II and cyclothymic disorders. People with bipolar I disorder experience episodes of both mania and depression, whereas those with bipolar II disorder experience depressive and hypomanic episodes, but never have a full manic episode. People with bipolar disorder are typically treated with mood stabilizers, antidepressants, atypical antipsychotics and anticonvulsants, but despite available medications, patients generally do not respond sufficiently to treatment. These patients often require multiple lines of therapy, which is associated with significant negative outcomes. People with bipolar II disorder are among those with the highest unmet need, due to the atypical symptomology and resistance to current treatment options they often experience.
About Neumora
Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Neumora Therapeutics, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including statements related to: Neumora’s intention to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases; the timing, progress and plans for its therapeutic development programs, including the timing of initiation and data read outs for its programs and studies, as well as its clinical trial and development plans; the potential for navacaprant to be a treatment for major depressive disorder, bipolar disorder, and other neuropsychiatric disorders and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release, are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results or to be materially different from the information expressed or implied by these forward-looking statements, including, among others: the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including CROs; risks related to serious or undesirable side effects of our therapeutic candidates; risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora’s business in general, please refer to the risk factors identified in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 that was filed with the SEC on May 7, 2024. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora undertakes no obligation to update or revise these forward-looking statements.
Neumora Contact:
Helen Rubinstein
315-382-3979
Helen.Rubinstein@neumoratx.com
FAQ
What is Neumora Therapeutics' new Phase 2 study about?
When will results from the Phase 2 navacaprant study be available?
What is the primary endpoint of the navacaprant Phase 2 study?
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What makes navacaprant's mechanism of action novel?
Is navacaprant being tested for other conditions besides bipolar depression?
When will data from the KOASTAL-1 Phase 3 study for MDD be available?
