This is a randomized, double-blind, placebo-controlled, multicenter study in participants with Parkinson's disease (PD) with motor fluctuations. Participants will be randomized to receive once-daily oral doses of either 75 milligrams (mg) CVN424, 150 mg CVN424, or a matching placebo for 12 weeks. Participants who successfully complete this study and retain eligibility/suitability will be invited to participate in a future open-label extension (OLE) study.

开始日期2024-09-20

申办/合作机构

Cerevance, Inc.

NCT06006247

/ Completed临床2期

A Randomized, Double-Blind, Placebo-Controlled Trial of CVN424 in Early Parkinson's Disease

This is a multicenter, 12-week, placebo-controlled clinical trial of CVN424 150 milligrams (mg) tablets in early, untreated Parkinson's Disease (PD). Participants will be randomized in a 1:1 ratio to CVN424 150 mg or placebo at the Baseline Visit. The purpose of this study is to measure effect on motor features with CVN424 tablets compared to placebo in early, untreated PD and to evaluate the potential of CVN424 to improve motor and non-motor functions in participants with early PD who are not taking dopaminergic or anti-PD therapies.

开始日期2023-09-11

申办/合作机构

Cerevance, Inc.

NCT05635461

/ Completed临床1期

A Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension &Tablet Formulations Including an Assessment of the Effect of Food on the Tablet Formulation in Healthy Adult Volunteers

This is a Randomized, Open-Label, Single Oral Dose, Three-Way Cross-Over Trial to Evaluate the Relative Bioavailability of CVN424 Suspension and Tablet Formulations in Healthy Volunteers Under Fasted and Fed Conditions.

开始日期2022-10-09

申办/合作机构

Cerevance, Inc.

100 项与 CVN-424 相关的临床结果

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100 项与 CVN-424 相关的转化医学

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100 项与 CVN-424 相关的专利（医药）

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项与 CVN-424 相关的文献（医药）

2024-12-03·Science Signaling

Structural insights into the high basal activity and inverse agonism of the orphan receptor GPR6 implicated in Parkinson’s disease

Article

作者: Lutomski, Corinne A. ; Bliesath, Joshua ; Barekatain, Mahta ; Sun, Hukai ; Popov, Petr ; Johansson, Linda C. ; Sadybekov, Anastasiia V. ; Cherezov, Vadim ; Saikatendu, Kumar S. ; Katritch, Vsevolod ; Han, Gye Won ; Liu, Zhi-Jie ; Russo, Joseph ; Carlton, Mark B. L. ; Schiffer, Hans H. ; Brice, Nicola L. ; Murphy, Sean T. ; Robinson, Carol V. ; Chang, Hao ; Lam, Jordy H. ; Monenschein, Holger ; Hua, Tian

GPR6 is an orphan G protein–coupled receptor with high constitutive activity found in D2-type dopamine receptor–expressing medium spiny neurons of the striatopallidal pathway, which is aberrantly hyperactivated in Parkinson’s disease. Here, we solved crystal structures of GPR6 without the addition of a ligand (a pseudo-apo state) and in complex with two inverse agonists, including CVN424, which improved motor symptoms in patients with Parkinson’s disease in clinical trials. In addition, we obtained a cryo–electron microscopy structure of the signaling complex between GPR6 and its cognate G s heterotrimer. The pseudo-apo structure revealed a strong density in the orthosteric pocket of GPR6 corresponding to a lipid-like endogenous ligand. A combination of site-directed mutagenesis, native mass spectrometry, and computer modeling suggested potential mechanisms for high constitutive activity and inverse agonism in GPR6 and identified a series of lipids and ions bound to the receptor. The structures and results obtained in this study could guide the rational design of drugs that modulate GPR6 signaling.

2024-11-01·eClinicalMedicine

CVN424, a GPR6 inverse agonist, for Parkinson's disease and motor fluctuations: a double-blind, randomized, phase 2 trial

Article

作者: Olanow, C Warren ; Ellenbogen, Aaron L ; Brice, Nicola L ; Kieburtz, Karl ; Dawson, Lee A ; Matthews, Kim L ; Carlton, Mark ; Dubow, Jordan ; Bexon, Martin ; Margolin, David H

BackgroundCVN424 is a GPR6 inverse agonist that provides selective pharmacological control of the indirect striatopallidal pathway. We assessed the safety and efficacy of CVN424 as an adjunctive treatment to levodopa for reducing OFF-time in individuals with Parkinson's disease (PD) experiencing motor-fluctuations.MethodsThis was a randomised, double-blind, placebo-controlled study conducted at 21 sites across the United States to evaluate two doses of CVN424 (NCT04191577). Patients with PD (Hoehn and Yahr stages 2-4) who were on a stable dose of levodopa and experiencing ≥2 h of daily OFF-time were randomised (1:1:1) to receive either once-daily CVN424 (50 mg or 150 mg) or placebo for a 28-day treatment period. The primary endpoints were safety and tolerability. The key secondary endpoint was the change from baseline to Day 27 in OFF-time.FindingsThe study was conducted from December 23, 2019, to October 14, 2021. Out of 198 participants screened, 141 eligible participants were randomised to one of the three treatment groups (n = 47 per group), and 127 participants completed the 28-day treatment period. The most common treatment emergent adverse events (TEAEs) were headache (2% with CVN424 50 mg, 9% with CVN424 150 mg, and 2% with placebo) and nausea (4% with CVN424 50 mg, 6% with CVN424 150 mg and 2% with placebo). No serious treatment-related adverse events were reported. On Day 27, the mean ± standard deviation (SD) change from baseline in daily OFF-time was -1.3 ± 3.0 h in the CVN424 50 mg group, -1.6 ± 2.5 h in the CVN424 150 mg group, and -0.5 ± 2.9 h in the placebo group. The placebo-adjusted LS mean ± standard error (SE) treatment difference was significant for the CVN424 150 mg dose (1.3 ± 0.56 h, [95 CI% -2.41 to -0.19], nominal p = 0.02).InterpretationTreatment with CVN424 was safe and well-tolerated. Despite the short study duration and small sample size, the 150 mg CVN424 dose provided a clinically meaningful reduction in daily OFF-time. This study supports the development of CVN424 for the treatment of PD.FundingCerevance.

2023-02-17·Organic Process Research & Development

Scalable Synthesis of CVN424, an Inverse Agonist of the GPR6 Receptor

作者: Mistry, Anil ; Zhou, Yusheng ; Mu, Changwei ; Doyle, Kevin J. ; Ye, Naidong ; Wang, Chunhua ; Yang, Yifang ; Bürli, Roland W. ; Li, Xiaolong

The process development of an efficient synthetic route that delivered several kilograms of the drug substance, CVN424, I was described.The synthesis of CVN424, I included diacylation of com. available 3,4-diaminopyridine with di-Et oxalate to give 1,4-dihydropyrido[3,4-b]pyrazine-2,3-dione and chlorination with POCl³ to give 2,3-dichloropyrido[3,4-b]pyrazine hydrochloride , followed by two sequential nucleophilic aromatic substitutions.A final hydrogenation and acetylation of intermediate II provided CVN424, I.Overall, a safe and robust synthesis was developed, which occurred in five linear steps with an overall yield of 15%.

项与 CVN-424 相关的新闻（医药）

2025-04-22

·PRNewswire

XADAGO/EQUFINA Set to Revolutionize Parkinson's Disease Treatment Landscape | DelveInsight

As a selective monoamine oxidase B (MAO-B) inhibitor, XADAGO offers a unique mechanism of action that complements traditional therapies, potentially improving motor function and reducing "off" time in patients. The increasing prevalence of Parkinson's disease and the growing demand for effective therapies create a substantial market opportunity for XADAGO, particularly in regions with aging populations. LAS VEGAS, April 22, 2025 /PRNewswire/ -- DelveInsight's " XADAGO/EQUFINA Market Size, Forecast, and Market Insight Report" highlights the details around XADAGO/EQUFINA, an inhibitor of monoamine oxidase B (MAO-B) indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of XADAGO/EQUFINA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Newron Pharmaceuticals/Eisai/Meiji Seika Pharma's XADAGO/EQUFINA (safinamide) Overview XADAGO is a monoamine oxidase B (MAO-B) inhibitor used alongside levodopa/carbidopa to help manage "off" episodes in individuals with Parkinson's disease. While its exact mode of action in treating Parkinson's is not fully understood, it is thought to work by inhibiting MAO-B, thereby reducing dopamine breakdown. This leads to increased dopamine levels and enhanced dopaminergic activity in the brain. XADAGO contains the active ingredient safinamide in the form of a mesylate salt and is available in 50 mg and 100 mg film-coated oral tablets. Each tablet provides either 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg of the safinamide base. The medication is marketed as XADAGO in the United States and Europe and under the name EQUFINA in Japan. Learn more about XADAGO/EQUFINA projected market size for Parkinson's disease @ XADAGO/EQUFINA Market Potential Parkinson's disease is a progressive neurological disorder that mainly impairs movement control. It results from the slow degeneration of dopamine-producing neurons in the brain, especially in the substantia nigra, a region crucial for managing voluntary motor function. According to estimates by DelveInsight, there were 2.7 million diagnosed prevalent cases of Parkinson's disease in the 7MM in 2023, with the United States accounting for around 45% of these cases. While a cure for Parkinson's remains elusive, a combination of pharmacological and non-pharmacological therapies is used to manage symptoms. Physical, occupational, and speech therapies form key components of treatment, and surgical procedures may benefit select patients. Additionally, complementary therapies are sometimes employed to help address particular symptoms. Frequently prescribed medications for Parkinson's include levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, anticholinergics, and adenosine A2A antagonists. These treatments primarily target motor symptoms, which are a major concern for those affected. DelveInsight reports that the Parkinson's disease market in the 7MM was valued at USD 3.2 billion in 2023. The market is expected to grow over the forecast period (2020–2034), fueled by the launch of new therapies, increasing prevalence, better access to healthcare, and rising demand for more advanced and effective treatment options. Discover more about the Parkinson's disease market in detail @ Parkinson's Disease Market Report Emerging Competitors of XADAGO/EQUFINA Some of the drugs in the pipeline include Solengepras (Cerevance), Minzasolmin (UCB Biopharma SRL/Novartis), Buntanetap (Annovis Bio), and others. Buntanetap has successfully completed Phase III trials for early-stage Parkinson's disease. Annovis Bio has scheduled a meeting with the FDA in Q1 2025 to determine the development path forward for Buntanetap in the treatment of Parkinson's disease. Buntanetap is also being developed for Alzheimer's disease, Lewy Body Dementia, and other neurodegenerative disorders. In November 2024, Cerevance announced the dosing of the first patient in its pivotal Phase III ARISE trial, evaluating solengepras as a potential adjunctive treatment for Parkinson's disease. Cerevance expects to report topline data in the first half of 2026. In December 2021, UCB partnered with Novartis to globally co-develop and co-commercialize UCB0599, a pioneering alpha-synuclein misfolding inhibitor currently in Phase II clinical trials for Parkinson's disease. To know more about the number of competing drugs in development, visit @ XADAGO/EQUFINA Market Positioning Compared to Other Drugs Key Milestones of XADAGO/EQUFINA In April 2020, Newron Pharmaceutical acknowledged that US WorldMeds, who held the US commercialization rights for the licensed drug, XADAGO, as a sub licensee of Zambon, had entered into a definitive agreement with Supernus Pharmaceuticals under which Supernus would acquire the CNS portfolio of US WorldMeds, including the US rights to XADAGO In November 2019, Eisai announced that it had launched the EQUFINA 50mg tablets for the indication of improvement of the wearing-off phenomenon in patients with Parkinson's disease under treatment with a drug containing levodopa in Japan. Manufacturing and marketing approval of EQUFINA was obtained in September 2019. In April 2017, Eisai Co., Ltd. and Meiji Seika Pharma announced entering into a license agreement for the commercialization of safinamide (development code: ME2125) to treat Parkinson's disease in Japan and Asia. In March 2017, Newron Pharmaceuticals announced the US FDA approval of XADAGO to treat Parkinson's disease as an add-on therapy to levodopa/carbidopa for patients experiencing "off" episodes. In March 2016, Zambon announced a strategic agreement with US WorldMeds to commercialize Newron's lead compound, XADAGO, to treat Parkinson's disease in the US. In February 2015, XADAGO was approved in the European Union as an add-on therapy to levodopa, alone or in combination with other Parkinson's medications, in mid-late stage PD patients with motor fluctuations. XADAGO/EQUFINA Patent Details XADAGO tablets are currently protected by three XADAGO patents with US patent numbers 8,076,515, 8,278,485, and 8,283,380, which expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The company has a license agreement with Zambon S.p.A., Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5-year FDA exclusivity period that expires on March 21, 2022. In May 2017, Zambon filed a worldwide patent under the patent number WO2017207587A1. The invention relates to pharmaceutical compositions comprising safinamide and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles, and a process for preparing them. Discover how XADAGO/EQUFINA is shaping the Parkinson's disease treatment landscape @ XADAGO 50mg XADAGO/EQUFINA Market Dynamics XADAGO, marketed as EQUFINA in some regions (notably in South Korea and Japan), is a once-daily oral selective MAO-B inhibitor used as an add-on treatment for Parkinson's disease patients experiencing "off" episodes while on a stable dose of levodopa. The drug's unique dual mechanism of action—MAO-B inhibition and modulation of glutamate release—offers both dopaminergic and non-dopaminergic effects, positioning it as a differentiated product in the PD adjunctive therapy landscape. This has helped it carve a niche in markets where patients are inadequately controlled by levodopa alone, particularly those in mid-to-late-stage PD. The global market dynamics for XADAGO/EQUFINA are shaped by a mix of competitive intensity, regional adoption trends, and payer dynamics. In the U.S. and Europe, the drug has faced stiff competition from generic MAO-B inhibitors (like selegiline and rasagiline) and newer Parkinson's disease therapies, including COMT inhibitors, dopamine agonists, and extended-release levodopa formulations. Despite this, its favorable safety profile and once-daily dosing have supported its uptake in certain patient segments, especially in Europe. Market penetration has been slower in the U.S. due to both reimbursement hurdles and physician preference for more established adjunctive treatments. In Asia, particularly Japan and South Korea, EQUFINA has demonstrated stronger market performance thanks to focused commercial strategies and a high unmet need for effective "off time" management. Meiji Seika Pharma and Eisai, the regional marketing partners, have successfully leveraged the drug's differentiated profile in clinician education, which has led to growing adoption among neurologists. In Japan, where the aging population is rapidly expanding and Parkinson's prevalence is rising, EQUFINA has benefited from both demographic tailwinds and formulary access. Looking ahead, the market outlook for XADAGO/EQUFINA depends on several strategic levers, including lifecycle management, regional partnerships, and real-world evidence generation. The manufacturer's ability to expand into new geographies, secure favorable reimbursement, and differentiate against both generics and newer entrants will be critical. Moreover, as Parkinson's disease treatment moves toward more personalized approaches, XADAGO/EQUFINA may find sustained relevance in specific subpopulations, particularly those requiring a balance of efficacy and tolerability. Dive deeper to get more insight into XADAGO/EQUFINA's strengths & weaknesses relative to competitors @ XADAGO/EQUFINA Market Drug Report Table of Contents Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, Cerevance, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapy in Parkinson's disease companies including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Sumitomo Pharma America Inc., Vanda Pharmaceuticals, Acadia Pharmaceuticals Inc., Otsuka America Pharmaceutical, Lundbeck LLC, Jazz Pharmaceuticals, Alkahest Inc., Sandoz, Sio Gene Therapies, Axovant Sciences Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准引进/卖出临床2期

2025-04-08

·GlobeNewswire-Health Care

Cerevance Presents Positive Results from Phase 1 Study of CVN293 at American Academy of Neurology 2025 Annual Meeting

CVN293 was generally well-tolerated in healthy volunteers with evidence of robust brain penetration, supporting utility of KCNK13 inhibitors for neurodegenerative diseases characterized by neuroinflammationAdditional AAN 2025 poster presentations highlight the company’s NETSseq platform and solengepras, a novel non-dopaminergic investigational treatment in clinical development to treat Parkinson’s disease BOSTON, April 08, 2025 (GLOBE NEWSWIRE) -- Cerevance, a clinical-stage biopharmaceutical company advancing multiple cell type-specific therapies for the treatment of neurodegenerative, psychiatric, and central nervous system-controlled metabolic disorders, today announced results from its Phase 1 trial of CVN293, a novel KCNK13 inhibitor targeting neuroinflammation. The data showed that CVN293 was generally well-tolerated in healthy adults following single and 14-day multiple dosing and showed evidence of robust brain penetration. The data was presented today in a poster session at the American Academy of Neurology (AAN) 2025 Annual Meeting in San Diego. “The favorable tolerability and pharmacokinetic profile observed with CVN293 in this first-in-human study are promising indicators for its potential as a disease-modifying intervention for neurodegenerative diseases driven by neuroinflammation,” said Sagar Vaidya, M.D., Ph.D., chief medical officer of Cerevance. “We look forward to advancing our family of KCNK13 inhibitors for the treatment of neurodegenerative disorders characterized by neuroinflammation, where new therapeutic options are urgently needed.” The randomized, double-blind, placebo-controlled Phase 1 single/multiple ascending dose (SAD/MAD) study evaluated the safety, tolerability and pharmacokinetics of oral CVN293 in 72 healthy adult volunteers. Study participants in the SAD part of the study received a single dose of CVN293 up to 1,000 mg or placebo (CVN293 n=36; placebo n=12) and those in the MAD part received repeated doses of CVN293 up to 750 mg (375 mg twice daily) or placebo over 14 days (CVN293 n=18; placebo n=6). Results showed that CVN293 was generally well-tolerated following single and 14-day multiple dosing, with 100% of participants completing the trial. There were no severe or dose-limiting adverse events (AEs), treatment-related discontinuations or clinically meaningful changes in vital signs or laboratory parameters. All related AEs were considered mild. In the SAD and MAD parts of the study, CVN293 plasma exposure increased in a generally dose proportional manner. Cerebrospinal fluid (CSF) sampling demonstrated high levels of central nervous system (CNS) exposure with CVN293. Additional Cerevance Presentations at AAN 2025The company presented a poster demonstrating the potential of its proprietary NETSseq platform to identify and/or validate cell-specific gene targets and biological insight into human brain disorders, which can be developed into novel therapies for neurodegenerative diseases. The poster detailed two clinical-stage novel therapeutic targets with specific expression in the brain that resulted from NETSseq: solengepras and CVN293. Another poster presentation will detail the novel mechanism of action of solengepras, an oral, non-dopaminergic therapy in clinical development for the treatment of Parkinson’s disease. A brain-penetrant, specific inhibitor of GPR6, solengepras is designed to selectively target and modulate the brain circuits responsible for controlling motor and non-motor functions without directly affecting dopaminergic pathways. This novel mechanism of action is designed to reduce motor complications, such as dyskinesia, decrease periods of symptomatic worsening, known as “OFF” time, and improve functional non-motor symptoms. The poster will describe the primary results of the randomized, double-blind, placebo-controlled Phase 2 ASCEND study of solengepras as monotherapy in patients with early, untreated Parkinson’s disease. This data was previously presented at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD™ 2025). About CVN293CVN293 is an investigational, highly selective oral inhibitor of the potassium two pore domain channel subfamily K member 13 (KCNK13). By selectively inhibiting KCNK13, a potentially novel regulator of NLRP3 inflammasome activation, CVN293 aims to reduce neuroinflammation and slow disease progression in a variety of neurodegenerative disorders. This mechanism may provide a disease-modifying approach for challenging central nervous system (CNS) disorders and obesity. KCNK13 was identified by Cerevance’s proprietary NETSseq platform. About Solengepras (formerly CVN424)Solengepras is designed to provide a potentially novel approach to the treatment of Parkinson’s disease. Unlike dopaminergic therapies, which primarily act by replenishing, enhancing, or mimicking dopamine, solengepras is designed to selectively address the indirect pathway by modulating the GPR6 receptor. By inhibiting GPR6, solengepras aims to restore both motor and non-motor function without directly affecting dopamine levels or signaling, improving the relative balance between the direct and indirect pathways, and potentially reducing the risk of common side effects associated with dopaminergic therapies, such as dyskinesias and motor fluctuations. Solengepras is currently being evaluated as a once-daily, oral treatment for use as an adjunctive therapy to levodopa and other anti-Parkinsonian medication in the Phase 3 ARISE trial. About CerevanceCerevance is focused on advancing cell type-specific therapies for the treatment of neurodegenerative, psychiatric and central nervous system-controlled metabolic disorders. Our proprietary platform, Nuclear Enriched Transcript Sort sequencing (NETSseq), allows us to identify targets that are expressed at very low levels, that are present in rare cell types, or that change over time as a disease progresses. Our most advanced investigational treatment, solengepras, is currently in Phase 3 development and has the potential to be a first-in-class, oral non-dopaminergic therapy for both the motor and non-motor symptoms of Parkinson's disease. Our second investigational therapy, CVN766, is designed to be a highly selective oral antagonist of the orexin 1 receptor for the potential treatment of binge eating disorder and schizophrenia. Our third investigational treatment, CVN293, is a highly selective investigational oral inhibitor targeting potassium two pore domain channel subfamily K member 13 (KCNK13). CVN293 represents a potentially novel intervention point for neurodegenerative disorders and obesity. For more information, please visit www.cerevance.com and follow us on LinkedIn and X. Contacts Cerevance:Johnna Simoes, ir@cerevance.com MediaApril Dovorany, adovorany@realchemistry.com, +1-262-909-8739

临床结果临床2期临床1期临床3期

2025-04-01

·FierceBiotech

Cerevance fails phase 2 trial in early, untreated Parkinson’s

The biotech blamed the miss on results for a physician-administered neurological exam.\n Cerevance’s attempt to unlock the first-line Parkinson\'s disease market has hit a snag, with solengepras performing no better than placebo in phase 2 when given to people with early, untreated symptoms. Boston-based Cerevance initially took solengepras, a GPR6 inverse agonist, into phase 2 as an adjunctive treatment to levodopa in Parkinson’s patients experiencing motor fluctuations. People who received the study drug had more daily time without symptoms, encouraging the biotech to start a phase 3 trial in the adjunctive setting and a midstage monotherapy study in early, untreated Parkinson\'s.Cerevance reported data from the phase 2 monotherapy study Tuesday. Solengepras was statistically no better than placebo on the MDS-UPDRS Parkinson’s clinical rating scale at Week 12, causing the trial to miss its primary endpoint.The biotech blamed the miss on results for a physician-administered neurological exam, which assesses physical signs of Parkinson’s at a single point in time. Cerevance saw “trends in improvement” on two patient-reported parts of the MDS-UPDRS endpoint but they fell short of statistical significance. Similarly, motor symptom and sleepiness endpoints favored solengepras without clearing the statistical bar. Cerevance CEO Craig Thompson said in a statement that the data align with findings from the phase 2 adjunctive therapy trial, with both studies demonstrating benefits on patient-reported measures. As the CEO sees things, the latest data reinforces that solengepras “appears to be more effective in impacting the functional and non-motor symptoms captured by patient-reported outcomes.”The primary endpoint of the phase 3 adjunctive therapy trial is looking at motor symptoms as reported in patient diaries. Several of the secondary endpoints also capture patient-reported measures. As such, Thompson’s reading of the phase 2 trial manages to frame the failure in a positive light for the phase 3.Whether Thompson’s positivity is justified could become clearer in the first half of next year, when the biotech expects to report topline data from the phase 3 study. The failed phase 2 trial was free from safety red flags, with all patients in the treatment arm completing the study and no participants experiencing serious adverse events related to solengepras.

临床2期临床结果临床3期

100 项与 CVN-424 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
并发症	临床3期	美国	Cerevance, Inc.	2024-09-20
并发症	临床3期	菲律宾	Cerevance, Inc.	2024-09-20
帕金森病	临床3期	菲律宾	Cerevance, Inc.	2024-09-20
帕金森病	临床3期	美国	Cerevance, Inc.	2024-09-20
精神运动障碍	药物发现	美国	Cerevance, Inc.	2019-12-02

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04191577 (Biospace) 人工标引	临床2期	帕金森病	-	solengepras 50 mg	(廠繭築選鏇醖壓醖淵願) = 積願鏇鹹膚鏇廠壓憲蓋齋簾淵鬱艱蓋膚繭繭膚 (鹽艱獵獵夢夢築廠餘構 )	积极	2024-10-21
				solengepras 150 mg	(廠繭築選鏇醖壓醖淵願) = 餘淵觸壓壓廠鏇製糧製齋簾淵鬱艱蓋膚繭繭膚 (鹽艱獵獵夢夢築廠餘構 )
NCT05635461 (CTgov)	临床1期	帕金森病	32	CVN424 (Treatment A: CVN424 150 mg Suspension (Fasted))	獵憲膚範膚網構糧簾鬱(構壓齋遞鹽醖構淵鬱鏇) = 簾衊膚簾鑰襯壓製齋夢餘壓選廠廠觸顧鹹構齋 (齋蓋淵廠淵觸網衊襯積, 艱鏇網範蓋網壓餘觸顧 ~ 簾選願淵憲憲鏇醖餘夢) 更多	-	2024-08-15
				CVN424 (Treatment B: CVN424 150 mg Tablet (Fasted))	獵憲膚範膚網構糧簾鬱(構壓齋遞鹽醖構淵鬱鏇) = 顧鬱製齋淵鬱鏇構繭鑰餘壓選廠廠觸顧鹹構齋 (齋蓋淵廠淵觸網衊襯積, 鑰膚網醖築夢淵蓋膚齋 ~ 蓋衊醖鬱膚獵製夢鹽衊) 更多
NCT04191577 (CTgov)	临床2期	精神运动障碍 \| 帕金森病	136	Placebo (Placebo Arm)	糧壓淵醖蓋鹹網鏇繭鏇(繭遞構遞膚膚壓壓築簾) = 憲膚鏇衊壓鹹壓糧醖積繭壓顧糧鹹廠蓋積簾獵 (夢構醖鏇選鹹鏇鏇醖構, 願淵窪艱範遞淵範鏇築 ~ 壓簾鬱觸鬱淵壓構觸蓋) 更多	-	2024-07-03
				CVN424 (CVN424 50 mg)	糧壓淵醖蓋鹹網鏇繭鏇(繭遞構遞膚膚壓壓築簾) = 積製觸憲壓簾淵艱窪範繭壓顧糧鹹廠蓋積簾獵 (夢構醖鏇選鹹鏇鏇醖構, 廠範簾衊廠製積醖遞鹹 ~ 網鹹廠鑰鑰遞廠餘夢製) 更多