An Open-label Safety Study of Dipraglurant (ADX48621) in Patients With Parkinson's Disease Receiving Levodopa-based Therapy With or Without Concomitant Dopaminergic Medications

This open-label study is designed to assess the long-term safety and tolerability of dipraglurant in PD patients for up to 52 weeks (at doses of 150-300 mg per day) for patients that have completed an Addex sponsored double-blind clinical trial of dipraglurant.

开始日期2021-10-25

申办/合作机构

Addex Pharma SA

NCT05027997 / Unknown status临床2期

Exploratory Phase 2a Randomized, Double-blind, Placebo-controlled Study of Dipraglurant (ADX48621) Immediate Release Tablets in Patients With Blepharospasm

This study is designed to assess the safety and tolerability of dipraglurant in patients with blepharospasm (BSP) (randomized 1:1:1 to receive dipraglurant 50 mg, 100 mg or placebo) and explore the efficacy of 50 mg and 100 mg immediate release tablets (versus placebo) on the severity and frequency of BSP signs and symptoms using objective measures, clinical ratings and patient reported outcomes.

开始日期2021-10-06

申办/合作机构

Addex Pharma SA

NCT04857359 / Unknown status临床2/3期

Phase 2b/3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Dipraglurant (ADX48621) for the Treatment of Dyskinesia in Patients With Parkinson's Disease Receiving Levodopa-based Therapy

This study is designed to evaluate the safety and efficacy of dipraglurant in PD patients with dyskinesia (randomized 1:1 to receive active or placebo) for 12 weeks (1 week at 150 mg per day and 11 weeks at 300 mg per day). The primary efficacy assessment will be based on the Unified Dyskinesia Rating Scale (UDysRS). Patients who complete the 12-week blinded treatment period may have the option to roll into an open-label safety extension study for an additional 12-month treatment period.

开始日期2021-08-06

申办/合作机构

Addex Pharma SA

100 项与 Addex Pharma SA 相关的临床结果

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0 项与 Addex Pharma SA 相关的专利（医药）

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项与 Addex Pharma SA 相关的文献（医药）

2016-11-01·Molecular and cellular endocrinology2区 · 医学

Profiling of FSHR negative allosteric modulators on LH/CGR reveals biased antagonism with implications in steroidogenesis

2区 · 医学

Article

作者: Jégot, Gwenhaël ; Poli, Sonia-Maria ; Dias, James A ; Ayoub, Mohammed Akli ; Reiter, Eric ; Poupon, Anne ; Yvinec, Romain ; Crépieux, Pascale

Biased signaling has recently emerged as an interesting means to modulate the function of many G protein-coupled receptors (GPCRs). Previous studies reported two negative allosteric modulators (NAMs) of follicle-stimulating hormone receptor (FSHR), ADX68692 and ADX68693, with differential effects on FSHR-mediated steroidogenesis and ovulation. In this study, we attempted to pharmacologically profile these NAMs on the closely related luteinizing hormone/chorionic gonadotropin hormone receptor (LH/CGR) with regards to its canonical Gs/cAMP pathway as well as to β-arrestin recruitment in HEK293 cells. The NAMs' effects on cAMP, progesterone and testosterone production were also assessed in murine Leydig tumor cell line (mLTC-1) as well as rat primary Leydig cells. We found that both NAMs strongly antagonized LH/CGR signaling in the different cell models used with ADX68693 being more potent than ADX68692 to inhibit hCG-induced cAMP production in HEK293, mLTC-1 and rat primary Leydig cells as well as β-arrestin 2 recruitment in HEK293 cells. Interestingly, differential antagonism of the two NAMs on hCG-promoted steroidogenesis in mLTC-1 and rat primary Leydig cells was observed. Indeed, a significant inhibition of testosterone production by the two NAMs was observed in both cell types, whereas progesterone production was only inhibited by ADX68693 in rat primary Leydig cells. In addition, while ADX68693 totally abolished testosterone production, ADX68692 had only a partial effect in both mLTC-1 and rat primary Leydig cells. These observations suggest biased effects of the two NAMs on LH/CGR-dependent pathways controlling steroidogenesis. Interestingly, the pharmacological profiles of the two NAMs with respect to steroidogenesis were found to differ from that previously shown on FSHR. This illustrates the complexity of signaling pathways controlling FSHR- and LH/CGR-mediated steroidogenesis, suggesting differential implication of cAMP and β-arrestins mediated by FSHR and LH/CGR. Together, our data demonstrate that ADX68692 and ADX68693 are biased NAMs at the LH/CGR in addition to the FSHR. These pharmacological characteristics are important to consider for potential contraceptive and therapeutic applications based on such compounds.

2016-09-01·Movement disorders : official journal of the Movement Disorder Society1区 · 医学

A Phase 2A Trial of the Novel mGluR5-Negative Allosteric Modulator Dipraglurant for Levodopa-Induced Dyskinesia in Parkinson's Disease

1区 · 医学

Article

作者: Keywood, Charlotte ; Tison, François ; Corvol, Jean-Christophe ; Bezard, Erwan ; Durif, Franck ; Trenkwalder, Claudia ; Lew, Mark ; Wakefield, Mark ; Isaacson, Stuart ; Poli, Sonia-Maria ; Goetz, Christopher G. ; Eggert, Karla ; Rascol, Olivier

BACKGROUND:

The metabotropic glutamate receptor 5-negative allosteric modulator dipraglurant reduces levodopa-induced dyskinesia in the MPTP-macaque model. The objective of this study was to assess the safety, tolerability (primary objective), and efficacy (secondary objective) of dipraglurant on levodopa-induced dyskinesia in Parkinson's disease (PD).

METHODS:

The study was a phase 2A double-blind, placebo-controlled, randomized (2:1), 4-week, parallel-group, multicenter dose-escalation (from 50 mg once daily to 100 mg 3 times daily) clinical trial involving 76 PD subjects with moderate to severe levodopa-induced dyskinesia. Safety and tolerability were assessed based on clinical and biological examination and adverse events recording. Secondary efficacy outcome measures included the modified Abnormal Involuntary Movement Scale, UPDRS, and diaries. Pharmacokinetics were measured at 3 visits following a single dose.

RESULTS:

Fifty-two patients were exposed to dipraglurant and 24 to placebo. There were no major safety concerns. Two subjects did not complete the study because of adverse events. Most frequent adverse events included dyskinesia, dizziness, nausea, and fatigue. Dipraglurant significantly reduced peak dose dyskinesia (modified Abnormal Involuntary Movement Scale) on day 1 (50 mg, 20%; P = 0.04) and on day 14 (100 mg, 32%; P =0 .04) and across a 3-hour postdose period on day 14 (P = 0.04). There was no evidence of worsening of parkinsonism. Dipraglurant was rapidly absorbed (tmax = 1 hour). The 100-mg dose led to a mean Cmax of 1844 ng/mL on day 28.

CONCLUSIONS:

Dipraglurant proved to be safe and well tolerated in its first administration to PD patients. Its efficacy in reversing levodopa-induced dyskinesia warrants further investigations in a larger number of patients. © 2016 International Parkinson and Movement Disorder Society.

2014-01-01·Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology1区 · 医学

Lentiviral Delivery of a Vesicular Glutamate Transporter 1 (VGLUT1)-Targeting Short Hairpin RNA Vector Into the Mouse Hippocampus Impairs Cognition

1区 · 医学

Article

作者: Le Poul, Emmanuel ; Papadopoulou, Nektaria ; Fone, Kevin C F ; Qin, Si ; Marsden, Charles A ; Kendall, David A ; Kurian, Nisha ; Epping-Jordan, Mark P ; Ray, David E ; King, Madeleine V ; Westerink, Ben H C ; Sharp, Tyson V ; Cremers, Thomas I

Glutamate is the principle excitatory neurotransmitter in the mammalian brain, and dysregulation of glutamatergic neurotransmission is implicated in the pathophysiology of several psychiatric and neurological diseases. This study utilized novel lentiviral short hairpin RNA (shRNA) vectors to target expression of the vesicular glutamate transporter 1 (VGLUT1) following injection into the dorsal hippocampus of adult mice, as partial reductions in VGLUT1 expression should attenuate glutamatergic signaling and similar reductions have been reported in schizophrenia. The VGLUT1-targeting vector attenuated tonic glutamate release in the dorsal hippocampus without affecting GABA, and selectively impaired novel object discrimination (NOD) and retention (but not acquisition) in the Morris water maze, without influencing contextual fear-motivated learning or causing any adverse locomotor or central immune effects. This pattern of cognitive impairment is consistent with the accumulating evidence for functional differentiation along the dorsoventral axis of the hippocampus, and supports the involvement of dorsal hippocampal glutamatergic neurotransmission in both spatial and nonspatial memory. Future use of this nonpharmacological VGLUT1 knockdown mouse model could improve our understanding of glutamatergic neurobiology and aid assessment of novel therapies for cognitive deficits such as those seen in schizophrenia.

项与 Addex Pharma SA 相关的新闻（医药）

2023-12-14

·GlobeNewswire-Health Care

Addex Creates Treasury Shares

Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, December 14, 2023 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development (“the Company”), announced today that 15,300,000 new registered shares at a nominal value of CHF 0.01 have been issued and fully subscribed by Addex Pharma S.A, its 100% wholly-owned subsidiary. The new shares, issued from the Company’s capital band, are listed on the SIX Swiss Exchange. The transaction has been executed to provide the Group with additional future financing flexibility. The issued share capital increased to CHF 1,782,344.96 representing 178,234,496 issued shares at a nominal value of CHF 0.01 each, whilst the number of outstanding shares remains unchanged. “The strengthening of our treasury share pool is an important part of our financing strategy to provide maximum future financing flexibility as we advance our portfolio of drug candidates,” said Tim Dyer CEO of Addex. “We expect data from the ADX71149 Phase 2 epilepsy study in the second quarter of 2024 and are currently focus on delivering drug candidates for our partner Indivior from our GABAB PAM program as well as advancing our other preclinical programs.” About Addex Therapeutics:Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available, small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional, non-allosteric molecules and may offer an improved therapeutic approach to conventional “orthosteric” small molecule or biological drugs. Addex’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2 clinical trial for the treatment of epilepsy. The company’s second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in post-stroke recovery. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates, with a focus on substance use disorder. Addex is also advancing a broad preclinical pipeline, which includes development of a range of GABAB PAM for chronic cough, mGlu7 NAM for stress related disorders, M4 PAM for schizophrenia and other forms of psychosis and mGlu2 NAM for mild neurocognitive disorders and depression. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange.   Contacts: Tim DyerChief Executive OfficerTelephone: +41 22 884 15 55 PR@addextherapeutics.com Mike SinclairPartner, Halsin Partners+44 (0)20 7318 2955msinclair@halsin.com Addex Forward Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the SEC on March 30, 2023, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

临床2期财报

2023-12-14

·BioSpace

Addex Creates Treasury Shares - December 14, 2023

Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, December 14, 2023 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development (“the Company”), announced today that 15,300,000 new registered shares at a nominal value of CHF 0.01 have been issued and fully subscribed by Addex Pharma S.A, its 100% wholly-owned subsidiary. The new shares, issued from the Company’s capital band, are listed on the SIX Swiss Exchange. The transaction has been executed to provide the Group with additional future financing flexibility. The issued share capital increased to CHF 1,782,344.96 representing 178,234,496 issued shares at a nominal value of CHF 0.01 each, whilst the number of outstanding shares remains unchanged. “The strengthening of our treasury share pool is an important part of our financing strategy to provide maximum future financing flexibility as we advance our portfolio of drug candidates,” said Tim Dyer CEO of Addex. “We expect data from the ADX71149 Phase 2 epilepsy study in the second quarter of 2024 and are currently focus on delivering drug candidates for our partner Indivior from our GABAB PAM program as well as advancing our other preclinical programs.” About Addex Therapeutics: Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available, small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional, non-allosteric molecules and may offer an improved therapeutic approach to conventional “orthosteric” small molecule or biological drugs. Addex’s allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex’s lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2 clinical trial for the treatment of epilepsy. The company’s second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in post-stroke recovery. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates, with a focus on substance use disorder. Addex is also advancing a broad preclinical pipeline, which includes development of a range of GABAB PAM for chronic cough, mGlu7 NAM for stress related disorders, M4 PAM for schizophrenia and other forms of psychosis and mGlu2 NAM for mild neurocognitive disorders and depression. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol “ADXN” on each exchange. Contacts: Tim Dyer Chief Executive Officer Telephone: +41 22 884 15 55 PR@addextherapeutics.com Mike Sinclair Partner, Halsin Partners +44 (0)20 7318 2955 msinclair@halsin.com Addex Forward Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the SEC on March 30, 2023, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

临床2期

2023-06-15

·GlobeNewswire-Health Care

Addex Increases Issued Share Capital to Create Treasury Shares

Ad Hoc Announcement Pursuant to Art. 53 LR Geneva, Switzerland, June 15, 2023 - Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development (“the Company”), announced today that it has increased its share capital from CHF 1,153,483.11 to CHF 1,329,483.11 through the issue of 17,600,000 new registered shares at a nominal value of CHF 0.01 each to Addex Pharma S.A, its 100% wholly-owned subsidiary. The new shares, issued from the Company’s capital band, are listed on the SIX Swiss Exchange. The transaction has been executed to provide the Group with additional future financing flexibility. The total number of issued shares increased to 132,948,311 at a nominal value of CHF 0.01 each, whilst the number of outstanding shares remains unchanged. “The strengthening of our treasury share pool is an important part of our financing strategy to provide maximum future financing flexibility as we advance our portfolio of drug candidates,” said Tim Dyer CEO of Addex. “Our partner Janssen continues to make excellent progress in recruiting patients in Cohort 2 of the epilepsy Phase 2 clinical study while we focus on delivery drug candidates for our partner Indivior from our GABAB PAM program and advancing our other preclinical programs.” About Addex Therapeutics:Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available, small molecule drugs known as allosteric modulators for neurological disorders. Allosteric modulators offer several potential advantages over conventional, non-allosteric molecules and may offer an improved therapeutic approach to conventional "orthosteric" small molecule or biological drugs. Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention. Addex's lead drug candidate, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2 clinical trial for the treatment of epilepsy. Addex's second clinical program, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in a range of indications. Indivior PLC has licensed Addex’s GABAB PAM program for the development of drug candidates, with a focus on substance use disorder. Addex is also advancing a broad preclinical pipeline, which includes development of a range of GABAB PAMs for CMT1A, chronic cough and several types of pain, mGlu7 NAM for stress related disorders, mGlu2 NAM for mild neurocognitive disorders and depression, M4 PAM for schizophrenia and other forms of psychosis, as well as mGlu4 PAM and mGlu3 PAM. Addex shares are listed on the SIX Swiss Exchange and American Depositary Shares representing its shares are listed on the NASDAQ Capital Market, and trade under the ticker symbol "ADXN" on each exchange. Contacts: Tim DyerChief Executive OfficerTelephone: +41 22 884 15 55 PR@addextherapeutics.comMike SinclairPartner, Halsin Partners+44 (0)20 7318 2955msinclair@halsin.com Addex Forward Looking Statements:This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements about the intended use of proceeds of the offering. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release, are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, uncertainties related to market conditions. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Addex Therapeutics’ Annual Report on Form 20-F for the year ended December 31, 2022, as filed with the SEC on March 30, 2023, the final prospectus supplement and accompanying prospectus and other filings that Addex Therapeutics may make with the SEC in the future. Any forward-looking statements contained in this press release represent Addex Therapeutics’ views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Addex Therapeutics explicitly disclaims any obligation to update any forward-looking statements.

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药物(靶点)	适应症	全球最高研发状态

ADX68692 ( FSHR )	子宫内膜异位症更多	临床前
Raseglurant ( mGluR5 )	胃食管反流更多	无进展
Dipraglurant ( mGluR5 )	帕金森病更多	无进展