AlgoTx Announces First Patients Dosed in US and European…

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.

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AlgoTx Progresses ATX01 in Two Indications

• 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.

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AlgoTx wins France Biotech’s 2023 ESG HealthTech Trophy

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.

AlgoTx Announces Initiation of Global Phase 2 Clinical Trial…

September 01, 2022 08:30 AM Eastern Daylight Time

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.

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FDA Grants AlgoTx IND Clearance for Phase 2 Trial…

June 01, 2022 11:34 AM Eastern Daylight Time

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).

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AlgoTx appoints Agathe Nadolny Chief Project Management Officer

Paris, Dec 16^th 2021 – 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”.

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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.

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AlgoTx completes Phase I for peripheral neuropathy program ATX01,…

Paris, Nov 15^th 2021

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.

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AlgoTx appoints Edmund Harrigan and Scott Byrd to the…

Paris, 12 April 2021 – 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.

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ATX01 enters Clinical Development

Paris, Feb 12^th 2021. France-based biotechnology company AlgoTx, developers of ATX01, an innovative topical treatment for chemotherapy-induced peripheral neuropathy (CIPN), announced today that ATX01 was administered to healthy volunteers participating in a Phase I study, designed to establish the product’s local and systemic tolerance in humans and ascertain its limited systemic passage. This is ATX01’s first administration in humans.

In November 2020, AlgoTx raised 12M€ in a Series A fundraising led by Bpifrance and Omnes Capital, with a view to developing ATX01 through to Phase II in CIPN. The initiation of this Phase I study is the first step in the timely execution of that plan.

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.

AlgoTx Receives Regulatory Approval to Initiate Clinical Development of…

PARIS, France, December 14th 2020 (BUSINESS WIRE)

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

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Analgesic Effects of Topical Amitriptyline in Patients with CIPN…

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AlgoTx raises €12M to take ATX01 into clinical development…

Paris, 24 November 2020 – 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.

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AlgoTx in Business Worldwide’s Top 20 Innovative Companies

https://www.prnewswire.com/news-releases/algotherapeutix-named-among-top-innovative-companies-to-watch-in-2020-by-business-worldwide-magazine-301173816.html

LONDON, Nov. 17, 2020 /PRNewswire/ — Paris based biotech company AlgoTx has made it to Business Worldwide Magazine’s list of Top 20 Innovative Companies to Watch in 2020.

The program is a celebration of trailblazing organizations who are changing the game in their respective industries and altering the corporate landscape. From a wide range of sectors, these companies are at the cutting edge of breakthrough technologies, innovation and modernized business structures. Those included in the list have a shared goal of developing revolutionary products and technology that drives scalable business models and disrupts established industries and markets.

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