subslover
11 months ago
Addex Announces ADX71149 Phase 2 Epilepsy Clinical Study’s Independent Interim Review Committee Recommends Continuing Study
Cohort 1 progressing through Part 2
Cohort 2 recruiting patients
Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland, May 10, 2023 - Addex Therapeutics (SIX and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced that the ADX71149 (JNJ-40411813) Phase 2 epilepsy clinical study has been recommended to continue by an Independent Interim Review Committee (IRC) following review of unblinded data from Part 1 of patient Cohort 1. The clinical study is being conducted by Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
“The recommendation of the IRC and the decision of our collaboration partner to continue the study is very encouraging and suggests ADX71149 is potentially safe and well tolerated and may have a positive impact on this patient population,” said Tim Dyer, CEO of Addex. “We look forward to providing further updates on the progression of this important clinical study in the second half of this year.”
ADX71149 is a selective metabotropic glutamate sub-type 2 (mGlu2) receptor positive allosteric modulator (PAM). The multi-center Phase 2 study has been designed to assess the efficacy, safety, tolerability, and pharmacokinetics of adjunctive ADX71149 administration in patients with focal onset seizures with suboptimal response to levetiracetam or brivaracetam. Up to 3 doses (low, medium, high) of ADX71149 in up to 160 patients will be evaluated. The primary objective of the study is to evaluate the efficacy of ADX71149 in combination with levetiracetam or brivaracetam using a time to baseline seizure count endpoint. Part 1 of the study evaluates the acute efficacy of ADX71149 over 4 weeks. Subjects who do not reach or exceed their monthly baseline seizure count in Part 1 continue double-blind treatment during Part 2 until they reach their monthly baseline seizure count or 8 weeks, deemed the maintenance efficacy phase. Cohort 1 has completed Part 1 and is currently in Part 2. Cohort 2 has started to recruit patients in Part 1. In addition, patients who complete Part 1 and/or Part 2 of the study have the option to continue treatment in the open-label extension part of the study, which evaluates the long-term efficacy and safety of ADX71149 for up to 2 years. More information on the study can be found with Clinicaltrials.gov identifier NCT04836559.
Glutamate mGlu2 Receptors and Epilepsy
Glutamate is the primary excitatory neurotransmitter in the brain and plays a key role in the initiation and spread of seizures. When activated, the mGlu2 receptor decreases the release of glutamate and consequently, helps to maintain neurotransmitter balance. In the presence of agonist-induced activation, positive allosteric modulation of mGlu2 receptors could result in the normalization of the excessive glutamate release seen during a seizure. There is still an urgent need for more effective treatments for epilepsy, with improved tolerability and safety. ADX71149 was described in the Eilat 15 conference summary review as a promising novel approach currently in development (Bialer et al., 2020. Epilepsia). Proof of concept data with ADX71149 and other mGlu2 PAMs in animal models of epilepsy have been published in peer-reviewed journals (Metcalf et al., 2017 and 2018. Epilepsia).
About Our Collaboration
Under the research collaboration and license agreement, Addex granted Janssen Pharmaceuticals, Inc. an exclusive worldwide license to develop and commercialize mGlu2 PAM compounds including ADX71149. Addex is eligible for up to a total of €109 million in success-based development and regulatory milestone payments. In addition, Addex is eligible for low double-digit royalties on net sales of compounds developed under the agreement.
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), 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.
Press Contacts
Tim Dyer
Chief Executive Officer
Telephone: +41 22 884 15 55
PR@addextherapeutics.com Mike Sinclair
Partner, Halsin Partners
+44 (0)7968 022075
msinclair@halsin.com
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 the ability to discover molecules as part of the Indivior collaboration, the progress of clinical trials and preclinical studies, including the timing of data read-outs from the ADX71149 epilepsy study, and our intended strategic direction. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “in
subslover
2 years ago
Addex Raises $4.2 million in Equity Financing
Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland, July 22, 2022 – Addex Therapeutics Ltd (SIX: ADXN and Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today announced that it has entered into a definitive agreement with Armistice Master Fund LTV, a healthcare-focused institutional investor, to sell 3,300,000 shares in the form of 550,000 American Depositary Shares (“ADSs”) at a gross purchase price of $1.70 per ADS, which is equivalent to CHF 0.27 per share. Each ADS represents six shares. Additionally, Addex has agreed to issue to Armistice Capital unregistered pre-funded warrants to purchase up to 11,700,000 shares in the form of 1,950,000 ADSs (the “Unregistered Pre-Funded Warrants”) at a funded amount of $1.69 with $0.01 payable on exercise as well as unregistered warrants to purchase up to 15,000,000 shares in the form of 2,500,000 ADSs (the “Unregistered Warrants” and together with the “Unregistered Pre-Funded Warrants”, the “Warrants”) in a concurrent private placement. The Unregistered Warrants have an exercise price of $1.90 per ADS, will become exercisable in 60 days after their date of issuance and will expire five years from their date of issuance.
The gross proceeds to Addex, before deducting offering expenses, will be $4.2 million. Addex intends to use the net proceeds from this offering to advance its clinical and preclinical pipeline1.
The closing of the offering is expected to occur on or about July 26, 2022, subject to the satisfaction of customary closing conditions.
The shares (but not the Warrants or the shares underlying the Warrants) are being offered by Addex pursuant to a "shelf" registration statement on Form F-3 that was originally filed on April 7, 2021 and declared effective by the Securities and Exchange Commission (“SEC”) on April 13, 2021 and the base prospectus contained therein (File No. 333-255089). The offering of the shares is being made only by means of a prospectus supplement that forms a part of the registration statement. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov.
The Warrants and shares underlying the Warrants are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares underlying the Warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the Warrants and underlying shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
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, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in a range of indications. Addex's second clinical program, ADX71149 (mGlu2 positi
subslover
2 years ago
Addex Provides Corporate Update and Financial Guidance
July 21 2022 - 01:00AM
GlobeNewswire Inc.
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Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland, July 21, 2022 - Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, today provided a corporate update, including a review of its pipeline and financial guidance.
“We completed the half year with CHF8.8 million of cash and expect to be able to finance our operations until the end of 2022. During this period, we will focus on concluding partnering agreements on selected pipeline assets to secure the financial resources to advance their development and strengthen our balance sheet,” said Tim Dyer, CEO of Addex. “In parallel, we look forward to the read out of data from the ADX71149 Phase 2 epilepsy study, conducted by our partner, Janssen, which is scheduled for the end of the year as well as delivering drug candidates, ready for IND enabling studies, under our strategic partnership with Indivior.”
Corporate Update
Cash and cash equivalents at June 30, 2022 of CHF8.8 million
Dipraglurant, mGlu5 NAM: Following termination of development in a pivotal Phase 2B/3 levodopa-induced dyskinesia associated with Parkinson's disease (PD-LID) study due to slow recruitment of patients and the consequential excessive costs of continuing development (announced June 17, 2022), we have initiated discussions with potential strategic partners to reinitiate Phase 2 development of dipraglurant in PD-LID or an alternative indication, including pain, substance use disorders (SUD), neurodevelopmental disorders and stroke.
ADX71149, mGlu2 PAM, licensed to Janssen Pharmaceuticals Inc., a Johnson and Johnson company, is in a Phase 2 study in epilepsy patients and on track to report data in Q4 2022. Under our agreement with Janssen, we are eligible to receive up to EUR 109 million in success-based development and regulatory milestone, and low double-digit royalties on net sales.
GABA B PAM Strategic Partnership with Indivior: Currently in clinical candidate selection phase with IND enabling studies expected to be initiated by Indivior in the first quarter of 2023 for SUD. Under the agreement with Indivior, in addition to research funding, we are eligible to receive $330 million in development, regulatory and sales milestones as well as the right to select drug candidates for development in certain exclusive indications outside of SUD. We plan to develop our selected drug candidates in pain and CMT1A.
mGlu7 NAM for the treatment of stress related disorders, including PTSD: A highly innovative first in class program, with a lead drug candidate ready to start IND enabling studies.
mGlu2 NAM for the treatment of mild neurocognitive disorders and depression: A well validated target with multiple differentiated drug candidates entering clinical candidate selection phase.
M4 PAM for the treatment of schizophrenia and other psychotic disorders: A well validated target for which Addex has identified multiple novel series of structurally differentiated selective M4 PAMs. These novel series of compounds have rapidly progressed into lead optimization and are anticipated to enter clinical candidate selection phase in 2023.
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, dipraglurant (mGlu5 negative allosteric modulator or NAM), is under evaluation for future development in a range of indications. Addex's second clinical p
subslover
2 years ago
Addex Completes Reduction in Nominal Value of Shares
July 21 2022 - 01:00AM
GlobeNewswire Inc.
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Ad Hoc Announcement Pursuant to Art. 53 LR
Geneva, Switzerland, July 21, 2022 - Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today the reduction of the nominal value of its issued, authorized and conditional share capital from CHF 1.00 to CHF 0.01, following the expiration of a period of two months after the third creditor call in The Swiss Gazette of Commerce in accordance with article 732 of Swiss Code of Obligations. The reduction was accepted by shareholders at the Annual General Meeting held on May 9, 2022. The issued share capital remains at 65,272,952 shares and the authorized and conditional capital remain at 32,636,476 shares, respectively. The revised nominal value of CHF0.01 is expected to become effective on the SIX Swiss Exchange on July 26, 2022.
“The reduction in the nominal value of our shares from CHF 1.00 to CHF 0.01 is an important step to removing technical barriers and ensuring future financing flexibility so we can deliver on the potential of our portfolio of drug candidates,” said Tim Dyer CEO of Addex.
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