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Augustine Therapeutics announces first patient dosed in Phase I clinical trial evaluating lead candidate AGT-100216 for the treatment of Charcot-Marie-Tooth disease
Augustine Therapeutics announces first patient dosed in Phase I clinical trial evaluating lead candidate AGT-100216 for the treatment of Charcot-Marie-Tooth disease

Yahoo

time27-05-2025

  • Business
  • Yahoo

Augustine Therapeutics announces first patient dosed in Phase I clinical trial evaluating lead candidate AGT-100216 for the treatment of Charcot-Marie-Tooth disease

AGT-100216 is the first HDAC6 inhibitor from Augustine's pipeline to enter clinical trials LEUVEN, Belgium – 27 May 2025– Augustine Therapeutics NV ('Augustine' or 'the Company'), a biotechnology company focused on developing new therapies for neuromuscular, neurodegenerative and cardio-metabolic diseases through the inhibition of the cytosolic Histone DeACetylase 6 (HDAC6) enzyme, today announces it has dosed the first patient in its Phase I clinical trial evaluating lead candidate AGT-100216, the first peripherally-restricted, selective HDAC6 inhibitor (HDAC6i) for the treatment of Charcot-Marie-Tooth disease (CMT). The Phase I trial is a randomized, double-blind, placebo-controlled, first-in-human trial, designed to evaluate the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of oral AGT-100216 in healthy adult volunteers. The trial is a combined two-part study evaluating single ascending and multiple ascending doses of AGT-100216. Gerhard Koenig, PhD, CEO of Augustine, said: 'The initiation of our first clinical trial is a major milestone for Augustine. Decades of research have validated the therapeutic potential of HDAC6 as a target but efforts to drug it to date have been sub-optimal. Augustine is developing a new generation of HDAC6 inhibitors, like AGT-100216, with a unique mechanism of action shown to be selective, safe and effective in pre-clinical trials. Having recently raised EUR 78 million / USD 85 million in an oversubscribed Series A financing round, and with a strengthened management team, the Company is entering a new stage of growth. We are well positioned to progress AGT-100216 through clinical development for CMT and to also advance our pipeline of next-generation HDAC6 inhibitors in significant cardio-metabolic and neurodegenerative diseases.' Media Contacts: Augustine TherapeuticsGerhard Koenig, CEOE-mail: info@ ICR Healthcare Amber Fennell, Ashley TappE-mail: augustinetx@ About Augustine Therapeutics Augustine Therapeutics is a biotechnology company focused on the treatment of neuromuscular, neurodegenerative and cardio-metabolic diseases through its next-generation approach to selectively inhibit HDAC6. Augustine's HDAC6 inhibitors have been purposefully designed to selectively inhibit HDAC6 while preserving its beneficial non-catalytic functions. Augustine's lead program, AGT-100216, is the first selective HDAC6 inhibitor for long-term treatment of Charcot-Marie-Tooth (CMT) disease. With its novel non-hydroxamate, non-hydrazide producing chemotype, Augustine's HDAC6 approach is selective, avoids the limitations of other chemotypes, and built for chronic diseases. With this novel approach, the Company will also be targeting diseases beyond CMT, including neurodegenerative and cardio-metabolic diseases. Augustine Therapeutics was founded on the ground-breaking research of Prof. Ludo Van Den Bosch from the VIB-KU Leuven in Belgium. The Company raised an oversubscribed EUR 78 million / USD 85 million Series A financing round in March 2025, led by Novo Holdings and Jeito Capital and supported by Asabys Partners, Eli Lilly and Company, AdBio partners, V-Bio Ventures, PMV, VIB, Gemma Frisius Fund, the US-based Charcot-Marie-Tooth (CMT) Research Foundation and Newton Biocapital. For more information visit About Charcot-Marie-Tooth (CMT) diseaseCharcot-Marie-Tooth (CMT) disease is a genetically heterogeneous group of hereditary peripheral neuropathies characterized by progressive distal nerve damage, primarily affecting the feet, legs, hands, and arms. The disorder damages peripheral nerves, causing muscle weakness, loss of sensation and other disabling symptoms. CMT is the most common inherited neuromuscular disorder with an estimated frequency of 1 in 2,500 people worldwide and there are currently no approved cures while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data

Augustine Therapeutics announces first patient dosed in Phase I clinical trial evaluating lead candidate AGT-100216 for the treatment of Charcot-Marie-Tooth disease
Augustine Therapeutics announces first patient dosed in Phase I clinical trial evaluating lead candidate AGT-100216 for the treatment of Charcot-Marie-Tooth disease

Yahoo

time27-05-2025

  • Business
  • Yahoo

Augustine Therapeutics announces first patient dosed in Phase I clinical trial evaluating lead candidate AGT-100216 for the treatment of Charcot-Marie-Tooth disease

AGT-100216 is the first HDAC6 inhibitor from Augustine's pipeline to enter clinical trials LEUVEN, Belgium – 27 May 2025– Augustine Therapeutics NV ('Augustine' or 'the Company'), a biotechnology company focused on developing new therapies for neuromuscular, neurodegenerative and cardio-metabolic diseases through the inhibition of the cytosolic Histone DeACetylase 6 (HDAC6) enzyme, today announces it has dosed the first patient in its Phase I clinical trial evaluating lead candidate AGT-100216, the first peripherally-restricted, selective HDAC6 inhibitor (HDAC6i) for the treatment of Charcot-Marie-Tooth disease (CMT). The Phase I trial is a randomized, double-blind, placebo-controlled, first-in-human trial, designed to evaluate the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of oral AGT-100216 in healthy adult volunteers. The trial is a combined two-part study evaluating single ascending and multiple ascending doses of AGT-100216. Gerhard Koenig, PhD, CEO of Augustine, said: 'The initiation of our first clinical trial is a major milestone for Augustine. Decades of research have validated the therapeutic potential of HDAC6 as a target but efforts to drug it to date have been sub-optimal. Augustine is developing a new generation of HDAC6 inhibitors, like AGT-100216, with a unique mechanism of action shown to be selective, safe and effective in pre-clinical trials. Having recently raised EUR 78 million / USD 85 million in an oversubscribed Series A financing round, and with a strengthened management team, the Company is entering a new stage of growth. We are well positioned to progress AGT-100216 through clinical development for CMT and to also advance our pipeline of next-generation HDAC6 inhibitors in significant cardio-metabolic and neurodegenerative diseases.' Media Contacts: Augustine TherapeuticsGerhard Koenig, CEOE-mail: info@ ICR Healthcare Amber Fennell, Ashley TappE-mail: augustinetx@ About Augustine Therapeutics Augustine Therapeutics is a biotechnology company focused on the treatment of neuromuscular, neurodegenerative and cardio-metabolic diseases through its next-generation approach to selectively inhibit HDAC6. Augustine's HDAC6 inhibitors have been purposefully designed to selectively inhibit HDAC6 while preserving its beneficial non-catalytic functions. Augustine's lead program, AGT-100216, is the first selective HDAC6 inhibitor for long-term treatment of Charcot-Marie-Tooth (CMT) disease. With its novel non-hydroxamate, non-hydrazide producing chemotype, Augustine's HDAC6 approach is selective, avoids the limitations of other chemotypes, and built for chronic diseases. With this novel approach, the Company will also be targeting diseases beyond CMT, including neurodegenerative and cardio-metabolic diseases. Augustine Therapeutics was founded on the ground-breaking research of Prof. Ludo Van Den Bosch from the VIB-KU Leuven in Belgium. The Company raised an oversubscribed EUR 78 million / USD 85 million Series A financing round in March 2025, led by Novo Holdings and Jeito Capital and supported by Asabys Partners, Eli Lilly and Company, AdBio partners, V-Bio Ventures, PMV, VIB, Gemma Frisius Fund, the US-based Charcot-Marie-Tooth (CMT) Research Foundation and Newton Biocapital. For more information visit About Charcot-Marie-Tooth (CMT) diseaseCharcot-Marie-Tooth (CMT) disease is a genetically heterogeneous group of hereditary peripheral neuropathies characterized by progressive distal nerve damage, primarily affecting the feet, legs, hands, and arms. The disorder damages peripheral nerves, causing muscle weakness, loss of sensation and other disabling symptoms. CMT is the most common inherited neuromuscular disorder with an estimated frequency of 1 in 2,500 people worldwide and there are currently no approved cures available.

Augustine Therapeutics builds its Management Team with Virginie Cartage joining as CFO and Dr. Andy Hu as CBO
Augustine Therapeutics builds its Management Team with Virginie Cartage joining as CFO and Dr. Andy Hu as CBO

Yahoo

time30-04-2025

  • Business
  • Yahoo

Augustine Therapeutics builds its Management Team with Virginie Cartage joining as CFO and Dr. Andy Hu as CBO

New recruits expand senior team capabilities as the business progresses its lead HDAC6 inhibitor program, AGT-100216, into the clinic for the treatment of Charcot-Marie-Tooth disease LEUVEN, Belgium – 30 April 2025 – Augustine Therapeutics NV ('Augustine' or 'the Company'), a biotechnology company focused on developing new therapies for neuromuscular, neurodegenerative and cardio-metabolic diseases through the inhibition of the cytosolic Histone DeACetylase 6 (HDAC6) enzyme, today announced the appointment of Virginie Cartage as Chief Financial Officer (CFO) and Dr. Andy Hu as Chief Business Officer (CBO). The two new additions to Augustine's leadership bring important and complementary new skills to the Augustine senior team including deep knowledge and expertise in finance, corporate finance, strategy, and business development. Their appointments follow Augustine's recently announced €78 million / $85 million Series A financing announcement plus the appointments of Pascale Witz as Board Chair and Gerhard Koenig as CEO earlier this year. Virginie Cartage, the newly appointed CFO of Augustine Therapeutics commented: 'It is a very exciting time to be joining the Augustine team as there is a real sense of momentum in the business. Augustine is well-funded, has highly differentiated science and is on the cusp of becoming a clinical-stage company. I am eager to leverage my financial expertise to help the company grow into its next phase of development.' Dr. Andy Hu, the newly appointed CBO of Augustine Therapeutics stated: 'I look forward to joining Augustine as a permanent member of the team. Having worked as an advisor, I have had a first-hand opportunity to appreciate the cutting-edge science behind Augustine's next-generation HDAC6 inhibitors (HDAC6i) and look forward to maximizing the opportunities ahead to fulfill the potential of our pipeline in significant cardio-metabolic and neurodegenerative diseases.' Gerhard Koenig, PhD, CEO of Augustine added: 'I look forward to working with both Virginie and Andy, whose skills will be invaluable as we advance our lead program into the clinic and further build our pipeline of HDAC6i to target a broad of clinical opportunities across significant diseases which lack novel therapeutic options.' Virginie joins Augustine from Novadip, a late-stage clinical biotechnology company specializing in regenerative medicine, where she served as CFO and played a pivotal role in the company's development during its first decade. Before Novadip, she held a number of senior finance positions in Belgium and Europe with big pharma companies including AbbVie and AstraZeneca after initiating her professional career at Deloitte. She received her Master of Economics from Université Catholique de Louvain and a Master's in Accounting and Audit from Katholieke Universiteit Leuven, complemented by a Management degree for the pharmaceutical sector. Prior to his appointment as CBO, Dr. Hu was an advisor to Augustine Therapeutics. Before joining Augustine, he served with Gerhard at Arkuda Therapeutics as Chief Business Officer. Arkuda, a biotech company focused on neurodegenerative diseases, was acquired by Johnson & Johnson in early 2025. Dr. Hu has served in multiple executive business and corporate development leadership roles, including at Dimension Therapeutics (acquired by Ultragenyx), Cubist Pharmaceuticals (acquired by Merck). His professional career in biotech includes work in strategic consulting at Strategic Decisions Group, and investment banking at Leerink Partners. Dr. Hu received his A. in Environmental Science and Public Policy from Harvard University, an MD from Baylor College of Medicine, and an MBA from the Jones Graduate School of Management at Rice University. Media Contacts: Augustine TherapeuticsGerhard Koenig, CEOE-mail: info@ ICR Healthcare Amber Fennell E-mail: augustinetx@ About Augustine Therapeutics Augustine Therapeutics is a biotechnology company focused on the treatment of neuromuscular, neurodegenerative and cardio-metabolic diseases through its next-generation approach to selectively inhibit HDAC6. Augustine's HDAC6 inhibitors have been purposefully designed to selectively inhibit HDAC6 while preserving its beneficial non-catalytic functions. Augustine's lead program, AGT-100216, is the first selective HDAC6 inhibitor for long-term treatment of Charcot-Marie-Tooth (CMT) disease. With its novel non-hydroxamate, non-hydrazide producing chemotype, Augustine's HDAC6 approach is selective, avoids the limitations of other chemotypes, and built for chronic diseases. With this novel approach, the Company will also be targeting diseases beyond CMT, including neurodegenerative and cardio-metabolic diseases. Augustine Therapeutics was founded on the ground-breaking research of Prof. Ludo Van Den Bosch from the VIB-KU Leuven in Belgium. The Company raised an oversubscribed EUR 78 million / USD 85 million Series A financing round in March 2025, led by Novo Holdings and Jeito Capital and supported by Asabys Partners, Eli Lilly and Company, AdBio partners, V-Bio Ventures, PMV, VIB, Gemma Frisius Fund, the US-based Charcot-Marie-Tooth (CMT) Research Foundation and Newton Biocapital. For more information visit

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