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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 raises oversubscribed EUR 78 million / USD 85 million Series A financing round
Augustine Therapeutics raises oversubscribed EUR 78 million / USD 85 million Series A financing round

Yahoo

time24-03-2025

  • Business
  • Yahoo

Augustine Therapeutics raises oversubscribed EUR 78 million / USD 85 million Series A financing round

Novo Holdings and Jeito Capital co-led the deal, supported by Asabys Partners and existing investors Proceeds to support the clinical development of lead candidate AGT-100216 for the treatment of Charcot-Marie-Tooth (CMT) disease, with Phase I trials starting imminently Pipeline of next-generation HDAC6 inhibitors (HDAC6i) also to be advanced in significant cardio-metabolic and neurodegenerative diseases LEUVEN, Belgium – 24 March 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 it has successfully completed its Series A financing round raising a total of EUR 77.7 million (USD 84.8 million). The oversubscribed financing was co-led by Novo Holdings and Jeito Capital, supported by existing investors Asabys Partners, who led an initial EUR 17.5 million closing in 2024, 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. HDAC6 is involved in neurodegeneration and tissue aging-related cellular processes, and pharmacologic inhibition of HDAC6 is a promising approach in a number of diseases. Augustine Therapeutics have designed a unique next-generation approach to selectively inhibit HDAC6 while preserving its beneficial non-catalytic functions. This novel non-hydroxamate, non-hydrazine producing approach seeks to avoid the limitations of previous HDAC6i and has significant potential in CMT, the most common hereditary disorder of the peripheral nervous system, affecting approximately three million people worldwide. With additional independent and differentiated programs focused on brain-penetrant and peripheral-restricted molecules, Augustine's pipeline of HDAC6 inhibitors has further potential in multiple diseases, including neurodegenerative and cardio-metabolic disorders. The Company's scientific foundation originates from the ground-breaking research of Prof. Ludo Van Den Bosch from the VIB-KU Leuven Center for Brain and Disease Research, who identified HDAC6 inhibition as a promising approach for the treatment of CMT and other neuropathies. Augustine was initially formed and seed-funded by V-Bio Ventures, AdBio Partners, VIB, PMV, and Gemma Frisius Fund. The Company recently appointed experienced biopharma leader Gerhard Koenig, PhD, who had served as Executive Chairman since June 2024, to lead the Company as CEO in January 2025. The proceeds will be used to advance Augustine's lead candidate, AGT-100216, through a Phase I/II proof-of-concept clinical trial in CMT. Beyond AGT-100216, Augustine has two other programs in discovery targeting peripherally-restricted and blood-brain barrier-penetrant HDAC6i for undisclosed neurodegenerative and cardio-metabolic indications. Gerhard Koenig, PhD, CEO of Augustine said: 'This significant financing is a testament to the innovative medicinal chemistry that Augustine was founded on, which acts via a unique mechanism of action. The therapeutic potential of HDAC6 is widely recognized in our industry, but previous drug approaches have been sub-optimal, particularly for chronic diseases. At Augustine, we believe we have solved these challenges with a novel non-hydroxamate, non-hydrazide producing chemotype which is highly selective and avoids the typical limitations of prior chemotypes, unlocking HDAC6 inhibition as a therapeutic approach. We now look forward to rapidly advancing our lead candidate into clinical trials for the treatment of CMT, while broadening the potential for our candidates to change treatment paradigms for neurological and cardio-metabolic diseases. I would like to thank our new and existing investors for their unwavering support as we continue to advance into clinical development.' Emmanuelle Coutanceau, PhD, Partner, Seed Investments, Novo Holdings, commented: 'Our mapping of the HDAC6i landscape has made us confident that Augustine's innovative and rigorous approach to medicinal chemistry has yielded molecules with potential to be best-in-class. HDAC6 inhibition shows great promise in many indications, and we are enthused to start our collaboration with Augustine's top-tier management team. Additionally, Augustine will be expanding its activities in Denmark, accessing a unique ecosystem and pool of talent which will support the exploration of HDAC6i in cardio-metabolic diseases.' Mehdi Ainouche, PharmD, Senior Principal, at Jeito Capital, said: 'This investment illustrates the potential of Augustine to bring exciting innovation in therapeutic areas where patients have limited or no treatment options. We are delighted to co-lead this financing to realize Augustine's potential, which stands out for both the quality of its research and the expertise of Gerhard and his team. We look forward to our future collaboration, which shares a common ambition: to accelerate clinical development in order to bring these innovations to patients.' Emmanuelle Coutanceau, PhD, Partner at Seed Investments, Novo Holdings, and Mehdi Ainouche, PharmD, Senior Principal at Jeito Capital have joined Augustine Therapeutics' Board of Directors. Annette Clancy, Operational Investor at Jeito Capital, and Marie Schroeder, PhD, Vice President at Seed Investments, Novo Holdings will join as Board Observers. # # #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. For more information visit Novo Holdings A/SNovo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people's health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S (Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Asia, Planetary Health and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. About Jeito Capital Jeito Capital is a global leading Private Equity fund with a patient benefit driven approach that finances and accelerates the development and growth of ground-breaking medical innovation. Jeito empowers and supports managers through its expert, integrated, multi-talented team and through the investment of significant capital to ensure the growth of companies, building market leaders in their respective therapeutic areas with accelerated patients' access globally, especially in Europe and the United States. Jeito Capital is based in Paris with a presence in Europe and the United States. For more information, please visit or follow us on LinkedIn or in to access your portfolio

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