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AlgoTx Announces “Last Patient Last Visit” in International Phase II Trial of ATX01 in Chemotherapy-Induced Peripheral Neuropathy

Paris, France, 24 Sept: AlgoTherapeutix (AlgoTx), a clinical stage biotechnology company developing a first-in-class therapeutic for peripheral neuropathic pain, ATX01, announced today the completion of the Last Patient Last Visit (LPLV) in its 276 patient Phase II trial known as ‘ACT (ATX01 in ChemoTherapy-induced peripheral neuropathy)’.

Conducted under the guidance of Professor Guido Cavaletti (Univ of Milano-Bicocca, Italy), ACT is an international, double-blind, placebo-controlled evaluation of ATX01’s efficacy and safety in patients suffering from CIPN, a common side effect of neurotoxic cancer treatments caused by nerve degeneration (1).

AlgoTx’s Founder, President & CEO, Stéphane Thiroloix said, “We’re delighted with the solid progress of our ACT clinical trial and are grateful to the patients, investigators and AlgoTx clinical team for their dedication in achieving this major milestone. The trial involved over 40 sites in the US, Belgium, Czechia, France, Italy, Poland and Spain, which is a significant undertaking, and commitment to making a difference, for any biotech company.”

AlgoTx’s Chief Development Officer, Philippe Picaut added, “CIPN affects two thirds of chemotherapy patients, representing a high unmet need without any approved treatments. We are enthused to see the last patient finish the study as we plan for the final development stages and hope to deliver the first approved treatment for CIPN.”

The company’s high-concentration, non-opioid ATX01 selectively targets specific nociceptive sodium channels in the peripheral nervous system involved in pain signaling. Its twice-daily local application provides sufficient concentrations to alleviate extreme pain whilst minimizing toxicity through limited systemic exposure.

Reference:

(1) “Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (ACT)”. The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% & 15%) versus placebo during a 12-week treatment period in treating CIPN in adult cancer survivor patients. Full details here: [link]

Announces successful recruitment of half of the patients in its ongoing three-arm 240-patient phase II trial in chemotherapy-induced peripheral neuropathy

Paris, France, 12 Sept: AlgoTherapeutix (AlgoTx), a clinical stage biotechnology company developing targeted, first-in-class therapeutics for peripheral neuropathic pain, announces it has dosed the first patients of up to 14, in the US and European centers of its phase II proof of concept trial, called EASE*. Under Orphan Drug Designation from FDA and EMA, this trial investigates the efficacy of the company’s lead asset ATX01 on the pain of Erythromelalgia, a rare neurological and vascular disease characterized by painful extremities for which there is no available treatment. The trial is due to read out in H1 2024.

The company’s innovative approach is focused on targeting specific nociceptive sodium channels involved in pain signaling through using a topical administration acting locally at the root of the pain and at a dose high enough to alleviate the extreme pain.

AlgoTx’s Founder, President & CEO, Stéphane Thiroloix said, “We’re delighted with the solid progress of our clinical trials and commend the clinical teams in the US and Germany for their dedication and progress towards this major milestone. We appreciate the dire need of Erythromelalgia patients for pain relief and are focused on providing them with our targeted therapeutics.”

The Universitaetsklinikum Erlangen Hautklinik’s Dr Juergen Bauerschmitz said, “The painful « flare-ups » of erythromelalgia can significantly impact quality of life. There is a high unmet medical need for this rare condition, which we often see in our dermatology clinic, which is one of the leading dermatology centers in Germany. I am delighted to be leading the European part of the phase II clinical trial of ATX01.”

The Mayo Clinic’s Julio Sartori Valinotti MD is involved in the research in the U.S.

The company also announces that it has completed, on schedule, the recruitment of approximately half of the patients in its three-arm 240-patient phase II trial (ACT) in chemotherapy-induced peripheral neuropathy (CIPN), a common side effect of neurotoxic cancer treatments caused by nerve degeneration.

AlgoTx’s innovative approach is focused on targeting specific nociceptive sodium channels in the peripheral nervous system involved in pain signaling through the administration of ATX01 as a twice daily topical hydrogel, acting locally and at a dose high enough to alleviate the extreme pain whilst minimizing toxicity through limited systemic exposure. The patient’s pain is reduced to a bearable level over time. In patients chronically affected by CIPN after having completed their chemotherapy, ATX01 may be a drug of choice for alleviating their pain and improving their quality of life.

Erythromelalgia affects around 1-2 per 100,000 people. There are around 5,000 EM patients in the US and around 7,000 in Europe. This condition primarily affects the feet, and less commonly, the hands, arms, legs, ears, and face. The condition can have ‘flare ups’ that last from minutes to days or be a continuous chronic condition. It is characterized by intense, burning pain, increases in skin temperature, swelling and severe redness (erythema) of the affected extremities.

* EASE stands for “Efficacy of ATX01 Study in Erythromelalgia”. The trial’s official title is “A Randomized, Double-blind, Placebo-controlled, 2-period, Crossover Study to Evaluate the Efficacy and Safety of ATX01 (Topical Amitriptyline Hydrochloride 15% w/w) in Adult Patients With Pain Due to Erythromelalgia (EM)”. Full details are here: https://clinicaltrials.gov/study/NCT05917912?cond=erythomelagia&rank=1

• First patients enrolled in ACT study in Chemotherapy-Induced Peripheral Neuropathy
• IND opened and Fast Track Designation granted by FDA for Erythromelalgia

Suresnes, France, March 30^th 2023.

European biotech AlgoTx, a clinical stage innovator in complex pain, today announces that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for its Phase 2 first-in-class candidate ATX01 in the treatment of erythromelalgia. Meanwhile, the first patients have been randomized into the “ATX01 for the pain of ChemoTherapy” (ACT) study in Chemotherapy-Induced Peripheral Neuropathy (CIPN). Both programs have been granted Fast Track Designation by the FDA.

AlgoTx is conducting the ACT study as part of its US / EU Phase 2 program in the indication of CIPN. The randomized, double-blind, placebo-controlled study aims to recruit 240 patients in more than 40 sites in the US, Belgium, Czech Republic, France, Italy, Poland and Spain.

Separately, FDA clearance of the IND for ATX01 in the indication of erythromelalgia opens the way for the Phase 2 “Efficacy of ATX01 Study in Erythromelalgia” (EASE) trial, a randomized, double-blind, placebo-controlled, cross-over study that will take place at the Mayo Clinic in the US and the Erlangen University Hospital in Germany. The study has also been approved by the German regulatory agency, BfArM.

Erythromelalgia is a rare neurovascular disease involving frequent episodes of swelling, redness, and often intense burning pain in the feet and/or hands of affected individuals. Episodes can be spontaneous or triggered by heat or exercise, and there is currently no cure for the condition nor any approved or consistently effective treatment available. AlgoTx has obtained an Orphan Disease Designation from both FDA and EMA to support development of ATX01 in this indication.

Dr Gabriel Fox, Chief Medical Officer of AlgoTx, commented: “This IND is further validation of our development work to date, and we are now eager to explore ATX01’s potential in this painful and distressing rare disease with the outstanding teams at the Mayo Clinic and Erlangen University Hospital.”

ATX01 is designed to inhibit pain messaging by directly targeting small sensory nerve fibers in the skin which generate and conduct pain messages from the peripheral nervous system to the spinal cord and brain. ATX01 acts locally to inhibit the nociceptive activity of voltage-gated sodium-channels Nav1.7, Nav1.8 and Nav1.9, in particular in peripheral sensory nerve fibers A∂ and C. Its systemic passage is minimal, enabling a favorable tolerance profile.

“With the ACT study in its active phase and the EASE study now on the launch pad, we look forward to bringing hope to those patients in extreme need of relief,  thanks to valuable support from our CRO partner Worldwide Clinical Trials, from the investigators and most importantly from the patients entering the study” said Dr Philippe Picaut, AlgoTx’s Chief Development Officer.

Paris, March 27th 2023. At France Biotech’s prestigious HealthTech Trophies Ceremony, AlgoTx was awarded the 2023 ESG HealthTech Trophy in recognition of the young biotech’s early commitment to ESG initiatives. On receiving the award on behalf of the AlgoTx team, Stéphane Thiroloix, CEO, commented that a small company can actually find it easier than a large one to define a course of action for ESG and execute consistently in that respect. He saluted the great work done by the NGO’s AlgoTx has been supporting : The Plastic Bank and Gribouilli.

SURESNES, France–(BUSINESS WIRE)–European biotech AlgoTx, the developer of first-in-class treatment ATX01 for chemotherapy-induced peripheral neuropathy (CIPN), announced today the success of a €20M Series B fundraising led by Relyens Innovation Santé / Turenne Capital , followed by UI Investissement, and historical investors Bpifrance through its Innobio 2 fund and Omnes Capital. Early and new business angel investors also significantly participated in this financing round, and AlgoTx secured an additional 1M€ in non-dilutive financing. The proceeds will be used to demonstrate the clinical efficacy of ATX01 in neuropathic pain.

“It is incredibly exciting to start the efficacy trials of ATX01, supported by such a high-profile syndicate of investors. We look forward to enrolling patients in our studies any day now.” Tweet this

Bervin Bouani, Investment Director at Turenne Capital, commented: “We are very proud to lead this strategic financing round to support AlgoTx to continue the clinical development of ATX01 lead candidate that has the potential to significantly improve the lives of patients with neuropathic pain. We look forward to working with Stéphane and his outstanding team to transform AlgoTx into a global pain player.”

Following the demonstration of ATX01’s early clinical safety and low systemic passage in Phase 1, the Phase 2 “ACT” study will now assess ATX01’s ability to reduce pain in adult CIPN patients – a program granted “fast-track” designation by FDA. In parallel, the Phase 2 “EASE” study will explore ATX01’s efficacy in the debilitating pain of erythromelalgia, a program for which ATX01 was granted “Orphan Disease Designation” in the US and Europe.

Stéphane Thiroloix, Founder & CEO of AlgoTx, says: “It is incredibly exciting to start the efficacy trials of ATX01, supported by such a high-profile syndicate of investors. We look forward to enrolling patients in our studies any day now.”

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. It affects over two million patients in the US and Europe and represents 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, neurologists and pain specialists.

“We are very pleased to support the AlgoTx team in the development of ATX01, driven by our belief in its significant impact in the treatment of CIPN and other neuropathic pain. AlgoTx can truly transform the lives of patients suffering from these conditions” , says Pauline de Breteuil Senior Partner UI Investissement / FCPI Majycc Innovation Santé.

About AlgoTx
AlgoTx develops novel treatments for complex pain, with lead program ATX01 in Phase 2 in chemotherapy-induced peripheral neuropathy (NCT05593614) and erythromelalgia. More information at www.algotx.com
ACT study : ATX01 for the pain of ChemoTherapy, (NCT05593614). EASE study : Efficacy of ATX01 / Study in Erythromelalgia.

ABOUT TURENNE GROUP/RELYENS INNOVATION SANTÉ
Launched in 2014, Relyens Innovation Santé is is an evergreen venture capital vehicle specializing in health innovation controlled and owned by Relyens, a mutual insurance company specializing in the risk management of health, social and medical players. Relyens is the leading French player in medical civil liability. Advised by Turenne Santé (Health Division of Turenne Group), Relyens Innovation Santé’s mission is to support the growth and development phases of innovative companies in the health sector.

Turenne Group, one of the leading private equity companies in France, has been supporting entrepreneurs for 23 years in their company’s innovation, development and transfer projects. As an independent player, the Group has assets of €1.4 billion under management. Its teams, made up of 68 professionals, including 52 investors, based in Paris, Lille (Nord Capital Partenaires), Lyon, Bordeaux, Marseille, Nice and Metz, support 290 business leaders, particularly in the healthcare, hospitality, innovation, BtoB services, and in the digital and impact sectors. With more than €300m, our healthcare team (Turenne Santé) invests across the entire value creation chain for healthcare companies through various investment approaches.
For more information: www.relyens.eu/fr / www.turennecapital.com

About Bpifrance and InnoBio 2
Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra financial services (training, consultancy) to help entrepreneurs meet their challenges (innovation, export).

InnoBio 2 is an investment fund dedicated to life sciences, managed by Bpifrance, which is also one of the LPs alongside Sanofi, Boehringer Ingelheim, Takeda, Ipsen, Servier, BMS, European Investment Fund and Pasteur Mutualité. InnoBio 2, with €203 million, aims to invest in companies developing innovative products and services, close to or in early clinical development, with the objective of bringing them until the clinical proof of concept. InnoBio 2 takes minority equity stake in companies and can lead or co-lead the investment rounds.

For more information, please visit: www.bpifrance.com – Follow us on Twitter : @bpifrance – @BpifrancePresse

About Omnes
Omnes is a leading Paris-based European investor in private equity and infrastructure. With more than €5 billion in assets under management, Omnes provides companies with the equity capital they need to grow through its four core businesses: Venture Capital, Buyout & Growth Capital, Infrastructure and Co-Investment. With more than 30 trade sales and nearly 15 IPOs in 20 years (including Themis Bioscience, Biovex, arGEN-X, Novaled and Direct Energie), Omnes Venture Capital team is a leading French player in financing innovative SMEs with dual expertise in the deep-tech and healthcare sectors. Omnes is committed to ESG issues and has set up the Omnes Foundation in aid of children’s charities. The company is also a signatory to the United Nations Principles for Responsible Investment (PRI). www.omnescapital.com

About UI Investissement
UI Investissement is an independent, specialized company in the development of unlisted French companies with €1.5 billion under management. For over 50 years, UI Investissement has been committed to work alongside the managers of growing SMEs and STIs to help them emerge as economically and sustainably successful businesses through its focus on three areas: health, agro-business, and business services.

With its expertise, UI Investissement provides support to companies in the health sector at all stages of their development and plays a central role in the ecosystem. It is through the Majycc Innovation Santé fund that UI Investissement supports entrepreneurs who aim to be the architects of tomorrow’s health. The roots of Majycc Innovation Santé are deeply connected to the DNA of several private clinic groups, nursing home groups, and mutual health insurance companies, representing entrepreneurship, health and human values, respect for corporate culture, and the projects of the individuals who build them.

SURESNES, France–(BUSINESS WIRE)–AlgoTx, a biotechnology company dedicated to developing treatments for complex pain, announced today the initiation of its Phase 2 global clinical trial in Chemotherapy-Induced Peripheral Neuropathy in adult patients. The trial will evaluate the efficacy and safety of two concentrations of ATX01 (proprietary topical amitriptyline).

ATX01 received Fast-Track designation from the US Food & Drug Administration last June for its development in CIPN. “We are excited to begin the ATX01 Phase 2 trial in CIPN”, said Stéphane Thiroloix, Founder and CEO of AlgoTx. “With meaningful efficacy data, we could come a significant step closer to offering millions of patients relief from their debilitating pain.”

The multicenter, randomized, double-blind, placebo-controlled trial seeks to enroll 240 adult patients with CIPN caused by platinum salts or taxanes in over 40 centers in the US and Europe. Initial results are expected in early 2024.

“Chemotherapy-induced neuropathic pain affects over half of chemotherapy patients and has no approved treatment,” commented Philippe Picaut, Chief Development Officer of AlgoTx. “Following successful pre-clinical and phase 1 clinical development, we are eager to confirm our efficacy hypothesis in patients in need of pain relief.”

About ATX01
ATX01 is a novel, patented, topical formulation of amitriptyline. Its non-systemic mode of action locally inhibits pain signaling in the skin’s nerve fibers whilst minimizing systemic penetration, thus avoiding unwanted toxicity.

Phase 1 clinical development showed favorable local and systemic tolerance in healthy volunteers and low systemic passage. The planned Phase 2 development will establish clinical efficacy in patients with chemotherapy-induced peripheral neuropathy.

The ATX01 Phase 2 plan recently gained clearance from FDA (IND) and from European countries involved in the trial, and FDA granted ATX01 a Fast-Track designation for its development in CIPN. ATX01 also benefits from Orphan Drug Designation for its development in erythromelalgia in both the US and the EU.

About AlgoTx
AlgoTx is a clinical-stage European biotech focused on developing innovative solutions for complex pain, with initial programs focusing on chemotherapy-induced neuropathic pain and erythromelalgia. AlgoTx has established partnerships with leading CRO’s and institutions to support the development of its programs.

Contacts: AlgoTx : contact@algotx.com. Communication: Geneviève CLIQUET Consultant –
www.algotx.com

European biotech AlgoTx, an innovator in complex pain therapy, today announces the U.S. Food and Drug Administration (FDA) cleared its Investigational New Drug Application (IND) for Phase 2 candidate ATX01 in the treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN).

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

ATX01 enjoys solid intellectual property including its patented topical formulation of amitriptyline designed to inhibit pain messaging by directly targeting small sensory nerve fibers in the skin which generate and conduct pain messages from the peripheral nervous system to the spine and brain. Indeed ATX01’s breakthrough pre-clinical investigation evidenced the anti-nociceptive activity of amitriptyline on voltage-gated sodium-channels Nav1.7, Nav1.8 and Nav1.9 and on peripheral sensory nerve fibers A∂ and C. ATX01’s Phase 1 program established safety in healthy volunteers and limited systemic passage designed to avoid the systemic side-effects of oral and injectable compounds.

Philippe Picaut, Chief Development Officer, commented: “This IND is a validation of our development work to date, and we are now eager to work alongside a large team of enthusiastic investigators in the US and Europe who share our goal of bringing relief to CIPN patients.”

FDA’s IND clearance opens the way for the planned Phase 2 study, a multi-center, double-blind, randomized, placebo-controlled study of ATX01 in the pain of CIPN in adult cancer survivors. The study aims to establish ATX01’s efficacy and safety in CIPN patients and will be conducted in the US and Europe.

“This IND is a major milestone for CIPN patients and for AlgoTx. In an indication without therapeutic solutions, ATX01’s highly differentiated mode of action has the potential to finally bring relief to patients with CIPN,” says Stéphane Thiroloix, AlgoTx’s founder and CEO.

About AlgoTx : AlgoTx is a European biotech founded in 2018 to develop innovative solutions for complex pain, whose Series A funding was led by Bpifrance and Omnes Capital. ATX01 is entering Phase 2 in painful peripheral neuropathy.

AlgoTx is a European Biotech developing ATX01, a non-opioid topical treatment for Peripheral Neuropathic Pain.

Stéphane Thiroloix, CEO, comments: “Project Management is a crucially important and arduous function in an R&D company. We are delighted to welcome such a talented expert as Agathe to the team”.

Agathe Nadolny, MSc, PMP^®, brings to AlgoTx over 20 years of experience in healthcare product management across R&D, manufacturing and strategic planning. She held positions of increasing responsibility at Bio-Rad from 2001 to 2017, eventually joining the Executive Committee as Project Management Office Manager. Prior to joining AlgoTx, Agathe was the New Product Launch Program Manager at French Pharma Mayoly Spindler.

Agathe joins AlgoTx just as the pivotal Phase II trial in is preparation. Her role involves the planning and coordination of all actions, parties and deliverables, not only in R&D but also on the general strategic roadmap of AlgoTx.

 

France-based biotechnology company AlgoTx, developer of ATX01, an innovative topical treatment for the pain of peripheral neuropathy, announced today that the ATX01 Phase I trial successfully reached its safety and pharmacokinetics objectives, clearing the way for Phase II development in Chemotherapy-Induced Peripheral Neuropathy (CIPN).

Stéphane Thiroloix, Founder & CEO of AlgoTx, comments: “The outcome of this Phase I trial is an important milestone for AlgoTx. We are delighted that ATX01’s innovative approach and formulation did not raise any safety concern, and its PK profile is consistent with our objectives. We are now busy preparing for the pivotal Phase II CIPN study.”

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 feet and hands:  loss of sensitivity, tingling, burning, cold and intense pain can persist for months to years after treatment. CIPN is a leading cause of 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.

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)

 

Founded in 2018 to design topical treatments for complex pain, AlgoTx is developing ATX01 in Chemotherapy-Induced Peripheral Neuropathy. Following the recent Series A fundraising and just as ATX01 initiates Clinical Development, AlgoTx is strengthening its Board of Directors with the appointment of two high-profile independent members.

 

Edmund P. Harrigan, M.D. has served as a director of Acadia since November 2015.

Ed served as Senior Vice President of Worldwide Safety and Regulatory for Pfizer Inc. from 2012 to 2015.

Ed’s previous executive leadership roles at Pfizer include Senior Vice President, Head of Worldwide Business Development, Senior Vice President, Head of Worldwide Regulatory Affairs and Quality Assurance, Vice President, Head of Neuroscience and Ophthalmology, Vice President of Clinical Development, Therapeutic Area Head, CNS and Pain.

He currently serves as a director of Acadia Pharma, Incyte Corporation and PhaseBio Pharmaceuticals, Inc., and is a member of the Scientific Advisory Boards of Alzheon, Inc. and Karuna Therapeutics, Inc.

Before entering the pharmaceutical industry in 1990, Ed was a practicing neurologist for seven years. Ed earned his B.A. degree in Chemistry from St. Anselm College, his M.D. from the University of Massachusetts, and trained in neurology at Boston University.

Scott Byrd currently serves as Chairman of the Board of Acacia Pharma Group plc., Founder/CEO of Pioneer Therapeutics, and is an Entrepreneur-inResidence with Frazier Life Sciences. Previously, he was Chief Executive Officer at Outpost Medicine, a Frazier portfolio company.

Prior to Outpost, Scott was President and Chief Operating Officer of Acacia Pharma, Inc. From 2009 to 2014, he was Senior Vice President and Chief Commercial Officer of Cadence Pharmaceuticals until its acquisition by Mallinckrodt Pharmaceuticals for $1.4 billion.

Earlier in his career, Scott served in a variety of roles of increasing responsibility at Eli Lilly and Company, including sales, marketing, development, manufacturing, and strategic planning.

Scott holds a B.S. in mechanical engineering from Bradley University and an M.B.A. from Harvard Business School.