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France-based biotechnology company AlgoTx, the developer of an innovative topical treatment for chemotherapy-induced peripheral neuropathy (CIPN), announced today it has received approval from the ethics committee and the regulatory authority in the Czech Republic to initiate a Phase 1 clinical trial with ATX01. The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021.

“I am thrilled by the entry of ATX01 in clinical development as it represents a great step forward towards providing CIPN patients with a response to the crippling pain they endure.”

Stéphane Thiroloix, Founder & CEO of AlgoTx

 

AlgoTx recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01. Given a positive outcome of the approved Phase 1 study, the company intends to initiate Phase 2 by the end of 2021.

Over half of cancer patients treated with chemotherapy – over two million patients in the US and Europe – develop CIPN and experience sensory symptoms and pain in the hands and feet: loss of sensitivity, tingling, burning, cold and intense pain can persist for months to years after treatment. CIPN is a leading cause for modification or interruption of chemotherapy. To this date, no therapeutic approach has offered a satisfactory response for patients and their caregivers, oncologists and pain specialists.

Over the last two years, AlgoTx took ATX01 from exploratory prototype to final formulation, established its pharmacological profile, conducted a full pre-clinical toxicology package, and scaled-up manufacturing to enable clinical supply production. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia.

A recent publication in the “Journal of Pain” describes the exploratory pharmacological impact of high-dose topical amitriptyline in CIPN patients along with the mechanism of action supporting its activity (https://doi.org/10.1016/j.jpain.2020.11.002)

 

France-based biotechnology company AlgoTx, the developer of an innovative topical treatment for chemotherapy-induced peripheral neuropathy (CIPN), has raised €12M in a Series A round led by Bpifrance through its InnoBio 2 fund with co-investor Omnes. Existing and new business angel investors, also significantly participated in this financing round. The proceeds will be used to fund the clinical development of its lead candidate ATX01 up to clinical proof of concept.

Over the last two years, AlgoTx took ATX01 from exploratory prototype to final formulation, established its pharmacological profile, conducted a full pre-clinical toxicology package, and scaled-up manufacturing to enable clinical supply production. In parallel, AlgoTx firmed-up ATX01’s development pathway via a pre-IND consultation with the FDA and obtained an Orphan Drug Designation from the FDA to explore ATX01’s activity in erythromelalgia. ATX01 is due to enter Phase I clinical trials in early 2021.

Inspired by clinical experience at a specialized pain treatment center, AlgoTx’s ATX01 targets topical treatment of CIPN by repositioning amitriptyline into a suitable topical formulation. The body of data from ATX01’s pre-clinical development now provides the pharmacological explanation for encouraging exploratory clinical observations with a precursor formulation published in early 2019.

Over half of cancer patients treated with chemotherapy develop CIPN and experience sensory symptoms and pain in the hands and feet:  loss of sensitivity, tingling, burning, cold and intense pain can persist for months to years after treatment. CIPN can prevent patients from walking or using their hands, thus deeply affecting their quality of life.

CIPN is found in over two million patients in the US and Europe, a leading cause for modification or interruption of chemotherapy. To this date, no therapeutic approach has offered a satisfactory response for patients and their caregivers, oncologists and pain specialists.

Stéphane Thiroloix, Founder & CEO of AlgoTx, says: “I am thrilled that such high-profile partners as Bpifrance and Omnes decided to support ATX01’s development journey towards a genuine relief for countless patients around the world.”

Thibaut Roulon, Investment Director at Bpifrance commented: “CIPN is a considerable unmet medical need. We are enthusiastic about AlgoTx’s innovative and pragmatic approach, which could significantly improve the quality of life for many cancer patients”.

“The AlgoTx team displayed scientific and operational strength in the early development of ATX01 and we are confident in their ability to establish the product’s clinical efficacy and safety going forward”, stated Claire Poulard, Principal at Omnes Capital.

Read full article: https://www.jpain.org/article/S1526-5900(20)30103-6/fulltext

 

AlgoTx – Developing novel treatments for pain control.

Chemotherapy-Induced Peripheral Neuropathy (CIPN) has always been an iceberg in the ocean of cancer care.  Underestimated and heavily consequential. AlgoTx, an innovative Paris based biotech focused on complex pain may well melt the iceberg. 

Chemotherapy-Induced Peripheral Neuropathy (CIPN) is an underestimated and devastating condition. Experienced by over 60 per cent of patients undergoing chemotherapy treatments, it ranks among the leading causes of chemotherapy modification or interruption, and is a cause of intense pain for patients.

A form of nerve damage to the skin of patients’ hands and feet, CIPN is most commonly associated with chemotherapies including platinum drugs, taxanes, vinca alkaloids (plant based drugs which block cell growth), proteasome inhibitors (drugs which prevent the degradation of protein within cells) and thalidomide derivatives used to stop cancer cells from developing).

The nerve damage caused by these chemotherapies produces symptoms which include burning, electric and stabbing sensations, numbness, tingling and allodynia – a condition which causes intense pain caused by normally painless stimuli.

Currently no FDA-approved therapy for CIPN exists. Despite the best efforts from their consultants, patients suffering from this crippling condition, have to endure severe pain and a reduced quality of life. “The debilitating pain which CIPN inflicts is not the only cause for concern. The condition often leads to chemotherapy dose reduction or termination, which may increase the chances of cancer-related morbidity and mortality,” explains Stéphane Thiroloix, CEO and Founder of AlgoTx.

To reduce the pain of the condition, clinicians will generally administer oral antidepressants and anticonvulsants. Whilst these yield some pain relief, they are limited and trigger taxing cardiovascular, neurological and neuromuscular side-effects. Indeed, reaching the right concentration in the skin requires the administration of high oral doses which in turn cause unwanted side-effects.

Developing a novel solution

It is therefore logical to look for an active compound with strong peripheral activity that can be administered directly into the skin with minimal passage in the bloodstream and therefore cause minimal systemic side-effects. A few attempts occurred to design a topical presentation of amitriptyline – indeed amitriptyline’s activity has a strong peripheral activity. Those attempts failed and the scientific community since then considered that amitriptyline is too complex to formulate for topical administration, probably difficult to protect with solid Intellectual Property, and possibly exposed to pricing challenges once approved.

In 2018 AlgoTx, led by pharma veterans Stéphane Thiroloix (CEO) and Olivier Bohuon, commenced development of their own revolutionary treatment to relieve patients of the pain experienced by CIPN – ATX01. The distinctive concept behind this new treatment being that through targeting the epidermis and dermis – the outermost layers of skin and predominantly the location of damaged nerve fibres with a high concentration amitriptyline gel, ATX01 will achieve strong efficacy. By contrast, its expected low systemic absorption will avoid the side-effects of oral treatment.

AlgoTx has now completed four vital stages of bringing ATX01 to market –

1. Filing a solid patent portfolio;
2. Applying formulation-by-design to develop a high-concentration formula with the intended penetration properties;
3. Demonstrating the local activity of amitriptyline on the peripheral nervous system;
4. Conducting a full pre-clinical plan which now makes ATX01 ready for testing on patients.

The innovative nature of ATX01 in revolutionising the administration of pain relief for chemotherapy and related treatments is undoubtedly due to the considerable knowledge and industry related experience of AlgoTx’ co-founders.

A start up with a difference

In contrast to the typical start-up, AlgoTx was founded by Stéphane Thiroloix and Olivier Bohuon, who are both pharma veterans. Stephane’s career journey has included prestigious roles at reputable R&D-based pharmaceutical corporates, including Executive Vice-President of Corporate Development at Ipsen – a leading biopharmaceutical group dedicated to improving lies through innovative medicines in oncology, neuroscience and rare diseases.

Equally, Olivier Bohuon has served as Chief Executive and Vice President for established global corporates within the pharmaceutical sector, including Smith & Nephew and Abbott Laboratories.

Backed by such illustrious expertise it is clear that AlgoTx’ innovative co-founders bring a wealth of top-to-bottom experience in the development, business development and commercialisation of pharmaceutical products.

Discussing this, Stéphane Thiroloix said, “Awareness of our limits is our main quality, and we have the ability to reach out to experts to go beyond these limits. We will now see ATX01 through its clinical development, with an aim of teaming up with suitable pharma partners for a 2025 commercial launch.”

From here, the door is open to exploring additional uses of ATX01, as its gel formulation and therefore simple method of administration may make it suitable for other forms of peripheral neuropathic pain.

FDA designation

This has been evidenced with the FDA recently granting AlgoTx an Orphan Drug Designation to study ATX01 in erythromelalgia – (Formally known as Mitchell’s Disease) – a rare and extremely painful disorder which causes severe burning pain and inflammation of the hands and feet.

“The ability to investigate ATX01 in erythromelalgia is an exciting medical pursuit as sufferers have very few options for pain relief. This provides us with opportunity to increase our understanding of ATX01’s activity on essential pain conduction mechanisms” states Stéphane.

Innovation can be measured on the dimensions of novelty and impact. Having challenged the consensus on CIPN and built a “silver start up” AlgoTx is likely to score highly on the impact scale when it brings genuine relief to millions of patients with CIPN and other forms of peripheral neuropathic pain.

source: https://www.bwmonline.com/2020/08/17/algotherapeutix-developing-novel-treatments-for-pain-control/

As our growth accelerates and we embark on the Series A funding round for the clinical development of ATX01, there could be no better time for Etienne Bienfait to join AlgoTx as Manager of Finance an Administration.

Etienne Bienfait

Etienne holds a degree from the University Technical Institute (IUT) in Saint Nazaire and a Research Master in Management from Brest Business School. He has a strong track record in financial controlling at Covage and Bryan Garnier.

AlgoTx is a French biotech start-up, hosted by the Paris Biotech Santé incubator developing ATX01, a treatment for Chemotherapy-Induced Peripheral Neuropathy.

• AlgoTherapeutix SAS
• 49 rue des Nouvelles – 92150 Suresnes
• Contact : contact@algotx.com

SURESNES, France- June 8th 2020 -(BUSINESS WIRE)–European biotech AlgoTx, an innovator in complex pain therapy, today announces the U.S. Food and Drug Administration (FDA) has granted ATX01 (proprietary topical amitriptyline) Orphan Drug Designation for the treatment of erythromelalgia.

This designation is given to medications with the potential to treat rare conditions — those that affect fewer than 200,000 people in the U.S. Benefits include exemption from fees, financial incentives for clinical development, and seven years of market exclusivity if the treatment is approved.

Erythromelalgia is a rare condition that primarily affects the feet and less commonly the hands. It is characterized by intense, burning pain, severe redness and increased skin temperature either episodic or almost continuous. Whilst erythromelalgia is deemed to result from vasomotor abnormalities or dysfunction in the normal constriction and dilation of the caliber of certain blood vessels, the pain of erythromelalgia is thought to be associated with sodium channel dysfunction.

The ATX01 program primarily targets Chemotherapy-Induced Peripheral Neuropathy. Via topical administration of a proprietary high-concentration amitriptyline gel, ATX01 aims to directly reach the damaged nerve fibers in the skin and avoid the systemic side-effects of oral and injectable compounds. Pre-clinical investigation evidenced the anti-nociceptive activity of topical amitriptyline on voltage-gated sodium-channels Nav1.7, Nav1.8 and Nav1.9 and on peripheral sensory nerve fibers Aβ, A∂ and C. With its pre-clinical development complete, ATX01 will enter into Phase I clinical development in late 2020.

“The opportunity to investigate ATX01 in erythromelalgia is an exciting medical pursuit as those patients have very few options to relieve considerable pain. It provides us with an opportunity to further our understanding of ATX01’s activity on Nav1.7 in a pre-clinical and clinical setting”, says Stéphane Thiroloix, AlgoTx’s founder and CEO.

hilippe was previously Sr VP Neurosciences R&D at Ipsen, based in Cambridge (USA). He joins us with a large experience in R&D and business development, in particular in the field of neurology. Philippe is a pharmacist and his qualifications include an MSc in fundamental and applied toxicology, an MSc in anatomopathology, and a diploma of the American Board of Toxicology.

Phillipe Picaut

Philippe brings a wealth of expertise as AlgoTx prepares to raise a Series A to launch ATX01 into clinical development for Chemotherapy-Induced Peripheral Neuropathy.

AlgoTx is a French biotech start-up, hosted by the Paris Biotech Santé incubator developing ATX01, a treatment for Chemotherapy-Induced Peripheral Neuropathy.

• AlgoTherapeutix SAS
• 49 rue des Nouvelles – 92150 Suresnes
• Contact : contact@algotx.com

AlgoTx announced today the appointment of Prof Roy Freeman to its Scientific Advisory Board.

Roy Freeman is Professor of Neurology at the Harvard Medical School and director of the Center for Autonomic and Peripheral Nerve Disorders in the Department of Neurology at Beth Israel Deaconess Medical Center in Boston, Massachusetts.

His research and clinical interests are the physiology and pathophysiology of the small nerve fibers and the autonomic nervous system. His research encompasses the neurological complications of diabetes; neuropathic pain; the autonomic complications of Parkinson’s disease and multiple system atrophy; biomarkers in neurodegenerative diseases; and the diagnosis and treatment of autonomic and peripheral nervous system disorders.

He has a special interest in clinical trial design in neuropathic pain in diabetic peripheral neuropathy and other peripheral nerve disorders. He has been principal investigator on many neuropathic pain clinical trials.  He is author of more than 200 original reports, chapters and reviews.

He is the principal investigator on National Institutes of Health-funded studies on the neurological complications of diabetes and biomarker development in alpha-synucleinopathies.

Dr. Freeman is former chairman of the World Federation of Neurology research group on the autonomic nervous system, former president of the American Autonomic Society and former chairman of the Autonomic Section of the American Academy of Neurology.  He serves on the Executive Committee and the Steering Committee of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION), a public-private partnership with the United States FDA.

He is Editor-in-Chief of Autonomic Neuroscience: Basic and Clinical and on the editorial boards of The Clinical Journal of Pain, Pain: Clinical Updates and Clinical Autonomic Research.

AlgoTx’ Scientific Advisory Board is chaired by Céline Greco (MD Phd), Hosp. Practitioner, Pain and Palliative Care Unit at the Hôpital Necker Enfants Malades in Paris. Céline heads up the Reference Center for Mastocytosis and Genetic Diseases with Cutaneous Expression. She is a laureate of the INSERM-Bettencourt school, and a Member of the Board  of the Council for Children Protection.

Roy Freeman joins the following members of the Scientific Advisory Board :

Philippe Arnaud, PharmD, is a Hospital Practitioner and Dpt Head at Bichat – Claude Bernard Hosp. He is a Professor at Paris Descartes Pharmacy & Biological Sciences University, and Erasmus teacher in Italy, Portugal and Canada. Philippe is a expert for the French National Medicines Agency (ANSM).

Jean-François Bergmann is Professor of Therapeutics at Paris VII University. He headed up the Internal Medicine and Infectious Diseases Dpt at Hôpital Lariboisière, Paris. He is the President of the Medicines Committee of the Assistance Publique – Hôpitaux de Paris (AP-HP). He served as expert with the Drug Approval Committee and the Transparency Committee of the French National Medicines Agency (ANSM), and expert with the European Medicines Agency (EMA).

Alain Eschalier is a pharmacist, a Medical Doctor and a Pharmacologist. He is Professor of Medical Pharmacology and former President of the Université d’Auvergne. Alain created and led several research units within INSERM and chairs the Analgesia Institute.

Axel Le Cesne is Associate Professor of Medicine. Head of Medical Oncology Hospital Unit at Gustave Roussy, France. He headed the Bone/Soft Tissue Sarcoma Unit from 1995 to 2016. Axel is a member of ASCO, ESMO, EORTC Soft Tissue and Bone Sarcoma Group (STBSG). He served as Co-chair & Secretary of the French Sarcoma Group 2001-2005 and has been a member of the Board of Directors of the Connective Tissue Oncology Society since 2010. Axel is a member of French Academy of Medicine.

Ronald Levy is Professor of Médecine, Stanford University Dpt of Oncology. He was awarded the Faisal International Prize, the Damashek Prize, the American Cancer Society’s Medal of Honor, the Leukemia and Lymphoma Society’s de Villiers Intl Achievement Award, the C. Chester Stock Award Memorial Sloan-Kettering Cancer Center, and the Karnofsky Award from the American Society of Clinical Oncology.

AlgoTx is a French biotech start-up, hosted by the Paris Biotech Santé incubator developing ATX01, a treatment for Chemotherapy-Induced Peripheral Neuropathy.