Cerevel Therapeutics in the NEWS
Cerevel Therapeutics (CERE) announced positive topline results from its pivotal Phase 3 TEMPO-3 trial for tavapadon, the first and only D1/D5 receptor partial agonist being studied as once a day treatment for Parkinson’s disease. The TEMPO-3 trial evaluated the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to levodopa in adults. The trial met its primary endpoint. Patients treated with tavapadon adjunctive to Levodopa experienced a clinically meaningful and statistically significant increase of 1.1 hours in total “on” time without troublesome dyskinesia compared to those treated with levodopa and placebo (1.7 hours vs. 0.6 hours, p <0.000. A statistically significant reduction in “off” time, the key secondary endpoint, was also observed for the tavapadon treatment arm.
Tavapadon
This product is the first and only selective D1/D5 receptor partial agonist in development for Parkinson’s disease and is currently being studied as a once daily for use as a monotherapy and as an adjunctive therapy to levodopa. Tavapadon is designed to activate D1/D5 receptors selectively and optimally to potentially provide the right balance of motor control, safety and tolerability for patients. By selectively activating D1/D5 dopamine receptors along the nigrostriatal pathway, tavapadon has the potential to offer the right balance of dopamine signaling to improve motor control while avoiding D2/D3 overstimulation, which is believed to underlie many of the side effects of current dopamine agonists.
Additionally, as a partial agonist with a 24-hour half-life enabling once-daily dosing, tavapadon may avoid hyperactivation of the dopamine receptors, which can lead to troublesome dyskinesias.
From Cerevel Therapeutics
Raymond Sanchez, M.D., chief medical officer, Cerevel Therapeutics said, “Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control, safety and tolerability. We are highly encouraged with the results announced today, and look forward to sharing additional data later this year from the monotherapy trials, TEMPO-1 and TEMPO-2, as we seek to evaluate tavapadon’s potential benefit to people living with Parkinson’s disease.”
Tavapadon was well tolerated. The safety profile observed in the TEMPO-3 trial was consistent with prior clinical trials of tavapadon. The majority of adverse events reported were mild to moderate in severity.
More from the Experts
Hubert H. Fernandez, M.D., global principal investigator and the James and Constance Brown endowed chair in movement disorders, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic said, “Parkinson’s disease is the fastest growing neurodegenerative disorder in the world, and a significant need exists for a new treatment option that provides the right balance of dopamine signaling and delivers sustained motor control without the burdensome side effects associated with current treatments. The results from the TEMPO-3 trial are particularly exciting as they demonstrate that tavapadon has the potential to offer an important new option for individuals living with this chronic, debilitating disease.”
Full results from the TEMPO-3 study will be submitted for presentation at future medical meetings and will be used to support regulatory submissions of tavapadon as a treatment for Parkinson’s disease.
Topline results from the Phase 3 monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2, are expected in the second half of the current 2024 year.
About TEMPO Clinical Development Program
The TEMPO clinical development program is evaluating the efficacy, safety and tolerability of tavapadon across a broad Parkinson’s population, including two monotherapy Phase 3 trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial (TEMPO-3). Cerevel is also conducting a fourth, open-label extension (OLE) trial (TEMPO-4) to assess the long-term safety and tolerability of tavapadon.
TEMPO-3 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to LD for advanced Parkinson’s disease. Patients were provided with a home diary to assess their motor function status (Hauser diary). The primary endpoint was change from baseline in the total “on” time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary. Key secondary endpoints included change from baseline in total daily “off” time, change from baseline in total “on” and “off” time at earlier timepoints in the trial, and change from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I, II and III Scores.
A total of 507 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson’s disease, were experiencing motor fluctuations and were on a stable dose of LD for at least 4 weeks prior to screening. Patients were randomized to receive either tavapadon adjunctive to LD, titrated to 5-15 milligrams, or placebo and LD, orally and once daily.
Parkinson’s disease is a chronic neurodegenerative disorder. It primarily results in progressive and debilitating motor symptoms, including decreased bodily movement, slowness of movement, rigidity, tremors and postural instability, all of which result from the loss of dopamine-producing neurons in the brain. A significant need exists for a new treatment option that has the right balance of dopamine signaling in order to provide sustained motor control without side effect tradeoffs across the disease spectrum.4,5 As of 2022, nearly 1 million individuals in the U.S. are estimated to be affected by Parkinson’s disease, which is expected to increase to over 1.6 million by 2037.
About Cerevel Therapeutics
Headquartered in Cambridge, Mass., Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases by combining its deep expertise in neurocircuitry with a focus on targeted receptor subtype selectivity and a differentiated approach to pharmacology. Cerevel Therapeutics has a diversified pipeline comprised of five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including schizophrenia, Alzheimer’s disease psychosis, epilepsy, panic disorder and Parkinson’s disease.
On December 6, 2023, Cerevel announced that it had entered into an agreement to be acquired by AbbVie. Cerevel continues to expect the merger to close in the middle of 2024, subject to receipt of regulatory approvals and other customary closing conditions specified in the merger agreement.
Special Note Regarding Forward-Looking Statements
Prohost Observations
The news from Cerevel Therapeutics is extremely promising as the trial results demonstrate that this firm’s product Tavapadon’s novel mechanism of action, selectively activates the D1/D5 dopamine receptors, demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control and safety of the dopamine product used by Parkinson’s Disease patients.
As you must have observed in the above news, there is a significant need for a novel treatment that can balance dopamine signaling in order to provide sustained motor control without side effect tradeoffs across the disease spectrum. Also, it is important to remember that around 1 million people in the United States are affected by Parkinson’s disease, that number is expected to increase to over 1.6 million by 2037.
Cerevel Therapeutics Stock
| Stock |
CERE |
| Price |
$42.14 |
| Market Cap |
$7.66 billion |
| 52-Week High |
$43.59 |
| 52-Week Low |
$19.59 |
Our 1 year target is $60, after next positive trial results, and $70 if CERE is taken over.
News & Comments
April 20, 2024
Cerevel Therapeutics Announces Positive Results for Tavapadon in Phase 3 Adjunctive Trial for Parkinson’s Disease
Cerevel Therapeutics in the NEWS
Tavapadon
This product is the first and only selective D1/D5 receptor partial agonist in development for Parkinson’s disease and is currently being studied as a once daily for use as a monotherapy and as an adjunctive therapy to levodopa. Tavapadon is designed to activate D1/D5 receptors selectively and optimally to potentially provide the right balance of motor control, safety and tolerability for patients. By selectively activating D1/D5 dopamine receptors along the nigrostriatal pathway, tavapadon has the potential to offer the right balance of dopamine signaling to improve motor control while avoiding D2/D3 overstimulation, which is believed to underlie many of the side effects of current dopamine agonists.
Additionally, as a partial agonist with a 24-hour half-life enabling once-daily dosing, tavapadon may avoid hyperactivation of the dopamine receptors, which can lead to troublesome dyskinesias.
From Cerevel Therapeutics
Raymond Sanchez, M.D., chief medical officer, Cerevel Therapeutics said, “Tavapadon’s novel mechanism of action, which selectively activates the D1/D5 dopamine receptors, has demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control, safety and tolerability. We are highly encouraged with the results announced today, and look forward to sharing additional data later this year from the monotherapy trials, TEMPO-1 and TEMPO-2, as we seek to evaluate tavapadon’s potential benefit to people living with Parkinson’s disease.”
Tavapadon was well tolerated. The safety profile observed in the TEMPO-3 trial was consistent with prior clinical trials of tavapadon. The majority of adverse events reported were mild to moderate in severity.
More from the Experts
Hubert H. Fernandez, M.D., global principal investigator and the James and Constance Brown endowed chair in movement disorders, professor of neurology and director at the Center for Neurological Restoration at Cleveland Clinic said, “Parkinson’s disease is the fastest growing neurodegenerative disorder in the world, and a significant need exists for a new treatment option that provides the right balance of dopamine signaling and delivers sustained motor control without the burdensome side effects associated with current treatments. The results from the TEMPO-3 trial are particularly exciting as they demonstrate that tavapadon has the potential to offer an important new option for individuals living with this chronic, debilitating disease.”
Full results from the TEMPO-3 study will be submitted for presentation at future medical meetings and will be used to support regulatory submissions of tavapadon as a treatment for Parkinson’s disease.
Topline results from the Phase 3 monotherapy trials for tavapadon, TEMPO-1 and TEMPO-2, are expected in the second half of the current 2024 year.
About TEMPO Clinical Development Program
The TEMPO clinical development program is evaluating the efficacy, safety and tolerability of tavapadon across a broad Parkinson’s population, including two monotherapy Phase 3 trials (TEMPO-1 and TEMPO-2) and one adjunctive Phase 3 trial (TEMPO-3). Cerevel is also conducting a fourth, open-label extension (OLE) trial (TEMPO-4) to assess the long-term safety and tolerability of tavapadon.
TEMPO-3 was a Phase 3 double-blind, randomized, placebo-controlled, parallel-group, flexible-dose, 27-week trial to evaluate the efficacy, safety and tolerability of tavapadon as an adjunctive therapy to LD for advanced Parkinson’s disease. Patients were provided with a home diary to assess their motor function status (Hauser diary). The primary endpoint was change from baseline in the total “on” time without troublesome dyskinesia based on the two-day average of the self-completed Hauser diary. Key secondary endpoints included change from baseline in total daily “off” time, change from baseline in total “on” and “off” time at earlier timepoints in the trial, and change from baseline in the Movement Disorder Society – Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part I, II and III Scores.
A total of 507 adults between the ages of 40-80 were enrolled in the trial. All had a confirmed diagnosis of Parkinson’s disease, were experiencing motor fluctuations and were on a stable dose of LD for at least 4 weeks prior to screening. Patients were randomized to receive either tavapadon adjunctive to LD, titrated to 5-15 milligrams, or placebo and LD, orally and once daily.
Parkinson’s disease is a chronic neurodegenerative disorder. It primarily results in progressive and debilitating motor symptoms, including decreased bodily movement, slowness of movement, rigidity, tremors and postural instability, all of which result from the loss of dopamine-producing neurons in the brain. A significant need exists for a new treatment option that has the right balance of dopamine signaling in order to provide sustained motor control without side effect tradeoffs across the disease spectrum.4,5 As of 2022, nearly 1 million individuals in the U.S. are estimated to be affected by Parkinson’s disease, which is expected to increase to over 1.6 million by 2037.
About Cerevel Therapeutics
Headquartered in Cambridge, Mass., Cerevel Therapeutics is dedicated to unraveling the mysteries of the brain to treat neuroscience diseases. The company is tackling diseases by combining its deep expertise in neurocircuitry with a focus on targeted receptor subtype selectivity and a differentiated approach to pharmacology. Cerevel Therapeutics has a diversified pipeline comprised of five clinical-stage investigational therapies and several preclinical compounds with the potential to treat a range of neuroscience diseases, including schizophrenia, Alzheimer’s disease psychosis, epilepsy, panic disorder and Parkinson’s disease.
On December 6, 2023, Cerevel announced that it had entered into an agreement to be acquired by AbbVie. Cerevel continues to expect the merger to close in the middle of 2024, subject to receipt of regulatory approvals and other customary closing conditions specified in the merger agreement.
Special Note Regarding Forward-Looking Statements
Prohost Observations
The news from Cerevel Therapeutics is extremely promising as the trial results demonstrate that this firm’s product Tavapadon’s novel mechanism of action, selectively activates the D1/D5 dopamine receptors, demonstrated the potential to provide people living with Parkinson’s disease the right balance of motor control and safety of the dopamine product used by Parkinson’s Disease patients.
As you must have observed in the above news, there is a significant need for a novel treatment that can balance dopamine signaling in order to provide sustained motor control without side effect tradeoffs across the disease spectrum. Also, it is important to remember that around 1 million people in the United States are affected by Parkinson’s disease, that number is expected to increase to over 1.6 million by 2037.
Cerevel Therapeutics Stock
Our 1 year target is $60, after next positive trial results, and $70 if CERE is taken over.
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