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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 appoints Rie Schultz Hansen, PhD as Chief Scientific Officer and establishes Copenhagen-based subsidiary
Augustine Therapeutics appoints Rie Schultz Hansen, PhD as Chief Scientific Officer and establishes Copenhagen-based subsidiary

Yahoo

time21-05-2025

  • Business
  • Yahoo

Augustine Therapeutics appoints Rie Schultz Hansen, PhD as Chief Scientific Officer and establishes Copenhagen-based subsidiary

New recruit expands 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 and continues building its pipeline in neurodegenerative and cardio-metabolic diseases Subsidiary Augustine Therapeutics Denmark ApS, located in Copenhagen, Denmark to serve as hub for the company's research work in cardio-metabolic medicine LEUVEN, Belgium – 21 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 announced the appointment of Rie Schultz Hansen, PhD, as Chief Scientific Officer, effective immediately. With more than 20 years' experience in drug discovery and early-stage drug development, Rie is an experienced executive with a strong background in cardio-metabolic and inflammation-driven diseases as well as peptide therapeutics. Prior to joining Augustine, she served as the Chief Scientific Officer at Aelin Therapeutics, where she played a key role in developing a degrader platform based on induced protein aggregation to neutralize disease-causing proteins. Later, she spearheaded an entrepreneurial initiative advancing AI/ML-based solutions derived from Aelin Therapeutics technology, securing initial funding and forging a collaboration for assay development and high-throughput screening capabilities. Rie spent the majority of her career at the peptide development specialist Zealand Pharma (CPH: ZEAL) where she worked across multiple functional areas, mainly focused on cardiovascular, metabolic and inflammatory diseases. Roles at Zealand Pharma included Innovation Officer, Vice President, Head of Discovery and Innovation, and Interim Chief Scientific Officer, governing the preclinical portfolio until CTA/IND submission and developing and implementing the strategy for research and chemistry for pre-clinical projects. Throughout her career Rie has maintained a strong connection with academia and has served for several years as a member of the Danish Cardiovascular Academy Grant committee. In addition, Augustine today announced the founding of a Copenhagen, Denmark based subsidiary, Augustine Therapeutics Denmark ApS, which will serve as the company's hub for research related to cardio-metabolic diseases. Gerhard Koenig, PhD, CEO of Augustine Therapeutics commented: 'Following the latest appointments of Virginie Cartage as Chief Financial Officer and Dr. Andy Hu as Chief Business Officer, I am pleased to further bolster our executive team. Rie's expertise will be instrumental in advancing Augustine's lead candidate, AGT-100216, through a Phase I/II proof-of-concept clinical trial in CMT and the Company's two other programs in discovery targeting peripherally-restricted and blood-brain barrier-penetrant HDAC6i for undisclosed neurodegenerative and cardio-metabolic indications. Rie's deep knowledge around the biology of cardio-metabolic diseases will provide critical leadership as we as we grow into our next stage as a clinical stage company with a deep HDAC6i pipeline pursuing a range of clinical applications.' Rie Schultz Hansen, PhD, Chief Scientific Officer of Augustine Therapeutics added: 'Augustine is at a significant juncture in its development. With the Company's novel and next generation approach to selectively inhibit HDAC6 and successful Series A fundraise, I am eager to leverage my experience in early-stage drug development and maximise the potential of the Company's highly differentiated pipeline as we proceed into the clinic. Furthermore, the establishment of our Danish subsidiary will drive the for the expansion of our efforts in applying HDAC6i in cardio-metabolic diseases and allow us to tap into the unique depth of cardio-metabolic R&D capabilities in the Danish region.' Rie received her Master's in Biology and PhD at the Faculty of Medicine, University of Copenhagen. She is also a board member of the Peptide Therapeutics Foundation and a member of the DCAcademy Grant Committee (University of Copenhagen) and obtained her post doctorate in cardiovascular research. Media Contacts: Augustine TherapeuticsGerhard Koenig, CEOE-mail: info@ ICR Healthcare Amber Fennell E-mail: augustinetx@ About Augustine TherapeuticsAugustine 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 existing investors 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 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

A promising new approach to treating potentially deadly liver disease
A promising new approach to treating potentially deadly liver disease

Yahoo

time07-05-2025

  • Health
  • Yahoo

A promising new approach to treating potentially deadly liver disease

An experimental new treatment is showing early promise in the fight against liver fibrosis – a serious and often silent condition that affects around 2 million people in the UK. Liver fibrosis happens when the liver becomes damaged – often due to long-term issues like alcohol use, obesity or chronic infections – and starts to develop scar tissue. Over time, that scarring can get worse and lead to serious complications such as liver failure or cancer. The problem is that most people don't know they have it until the damage is advanced. And there are no approved drugs to stop or reverse the scarring process. ADVERTISEMENT In a recent study, my colleagues and I found that blocking an enzyme called HDAC6 with new drugs could help reduce liver scarring in people with liver fibrosis. This discovery could form the basis of future treatments and offer hope for those living with chronic liver conditions. Get your news from actual experts, straight to your inbox. Sign up to our daily newsletter to receive all The Conversation UK's latest coverage of news and research, from politics and business to the arts and sciences. Join The Conversation for free today. Fibrosis occurs when the liver responds to injury by producing too much of the material that normally helps repair tissue, known as the 'extracellular matrix'. Over time, this repair process can become unbalanced, leading to a buildup of scar tissue. A key part of this process involves hepatic stellate cells. When the liver is injured, these normally inactive cells become activated and turn into scar-producing cells that drive fibrosis. ADVERTISEMENT HDAC6 helps control how cells respond to stress and inflammation and how they move and organise themselves. Our recent research suggests it also plays an important role in turning on the liver cells that cause scarring after injury. That's why we're exploring HDAC6 as a potential target for new treatments that could help prevent or even reverse liver fibrosis. In our lab, we developed two new drugs specifically designed to block HDAC6 activity. Liver slices To see if these compounds could be useful as treatments, we tested them on precision-cut slices of human liver tissue at Newcastle University. This model keeps the liver's natural 3D structure and mix of cells, making it a valuable way to study how diseases develop and how drugs might work. Our results were striking. Treating the liver slices with HDAC6 inhibitors greatly reduced signs of fibrosis, showing that these compounds can stop – and possibly even reverse – the scarring process at the cellular level. ADVERTISEMENT The inhibitors showed very little toxicity, suggesting they could be safe for further development. This research is a step forward in finding a treatment for liver fibrosis. Unlike previous treatments that targeted broad mechanisms or caused side-effects, our HDAC6 inhibitors provide a more targeted approach. By focusing on a key cause of fibrosis, we may be able to stop the disease before it reaches irreversible stages. The implications are enormous. Liver disease is responsible for around 4% of premature deaths globally, and the burden is rising in line with alcohol misuse, obesity, and the use of multiple medications (known as 'polypharmacy'). A targeted therapy that interrupts fibrosis at its root could change the lives of tens of thousands of patients annually – not only in the UK but around the world. While these early findings are encouraging, more work is needed before HDAC6 inhibitors can be tested in humans. Our next steps include refining the experimental drugs, testing their effects in lab animals, and looking at how they might work alongside existing treatments. ADVERTISEMENT As researchers and healthcare professionals seek new ways to tackle chronic diseases, targeted approaches like this one could redefine how we treat conditions once considered untreatable. For patients with liver fibrosis, this new knowledge could mean a longer, healthier life for millions of people with liver fibrosis. This article is republished from The Conversation under a Creative Commons license. Read the original article. Maria Teresa Borrello does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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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