Month: March 2023

• 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.