amitriptyline topical (ATX01) / AlgoTx - LARVOL DELTA

AlgoTx Announces Results of its Phase 2 “ACT” Trial of ATX01 in Chemotherapy-Induced Peripheral Neuropathy (GlobeNewswire) - P2 | N=276 | NCT05593614 | Sponsor: AlgoTherapeutix | "AlgoTherapeutix...announced today the completion of its 276 patient Phase 2 trial known as ‘ACT’...ACT provided encouraging signals of ATX01 efficacy, particularly at the higher concentration of 15%. However, the high level of placebo effect experienced in several study sites prevented the overall separation of the pain response curves for ATX01 and placebo. In a post-hoc analysis in low-placebo sites, ATX01 15% showed statistically significant superiority to placebo on most primary and secondary endpoints. ATX01 was well tolerated...'Whilst we have seen encouraging signs of clinical efficacy with ATX01 we did not hit our primary endpoint due to a strong placebo effect in some centers.'"

P2 data • Trial completion • Peripheral Neuropathic Pain

ACT: Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (clinicaltrials.gov) - P2 | N=276 | Active, not recruiting | Sponsor: AlgoTherapeutix | Recruiting ➔ Active, not recruiting | Trial completion date: May 2024 ➔ Sep 2024 | Trial primary completion date: May 2024 ➔ Sep 2024

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Pain

EASE (Efficacy of ATX01 Study in Erythromelalgia) (clinicaltrials.gov) - P2 | N=14 | Completed | Sponsor: AlgoTherapeutix | Recruiting ➔ Completed

Trial completion • Pain

EASE (Efficacy of ATX01 Study in Erythromelalgia) (clinicaltrials.gov) - P2 | N=14 | Recruiting | Sponsor: AlgoTherapeutix | Trial primary completion date: Nov 2023 ➔ Feb 2024

Trial primary completion date • Pain

ACT: Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: AlgoTherapeutix | Trial completion date: Dec 2023 ➔ May 2024 | Trial primary completion date: Dec 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Oncology • Pain

AlgoTx Announces First Patients Dosed in US and European Arms of Phase II Clinical Trial of ATX01 in Rare Disease Erythromelalgia (BioSpace) - "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."

Enrollment status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

EASE (Efficacy of ATX01 Study in Erythromelalgia) (clinicaltrials.gov) - P2 | N=14 | Recruiting | Sponsor: AlgoTherapeutix | Not yet recruiting ➔ Recruiting

Enrollment open • Pain

EASE (Efficacy of ATX01 Study in Erythromelalgia) (clinicaltrials.gov) - P2 | N=14 | Not yet recruiting | Sponsor: AlgoTherapeutix

New P2 trial • Pain

AlgoTx Progresses ATX01 in Two Indications (Businesswire) - "European biotech AlgoTx...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)."

IND • Trial status • CNS Disorders • Oncology • Pain • Peripheral Neuropathic Pain

AlgoTx Raises €20M to Conduct ATX01’s Phase 2 Program in Peripheral Neuropathic Pain (Businesswire) - "European biotech AlgoTx...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."

Financing • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

ACT: Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: AlgoTherapeutix | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pain

ACT: Efficacy and Safety of ATX01 in Adult Patients With CIPN (Chemotherapy-induced Peripheral Neuropathy) (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: AlgoTherapeutix

New P2 trial • Oncology • Pain

AlgoTherapeutix Announces Initiation of Global Phase 2 Clinical Trial of ATX01 for the Relief of Pain in Chemotherapy-induced Peripheral Neuropathy in Adults (Businesswire) - "AlgoTx...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)....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."

New P2 trial • CNS Disorders • Pain • Peripheral Neuropathic Pain

A multicenter, randomized, double-blind, Phase 2 study to assess ATX01 (topical study drug) in comparison to placebo, in cancer adult patients with chemotherapy-induced peripheral neuropathy (CIPN) Estudio de fase II multicéntrico, aleatorizado, doble ciego, para evaluar ATX01 (farmaco tópico) en comparación con el placebo, en pacientes adultos con neuropatía periférica in (clinicaltrialsregister.eu) - P2 | N=240 | Ongoing | Sponsor: AlgoTherapeutix

New P2 trial • Neuralgia • Oncology • Pain • Peripheral Neuropathic Pain

AlgoTx’s ATX01 Granted Fast Track Designation by FDA for Chemotherapy-Induced Neuropathic Pain (Businesswire) - "AlgoTx announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA), for the development of ATX01 in chemotherapy-induced neuropathic pain....'we look forward to interacting closely with the FDA to bring relief to patients as quickly as possible'....ATX01 recently obtained an IND for its Phase 2 trial in CIPN due to start in late 2022, and an Orphan Drug Designation for development in erythromelalgia."

Fast track designation • New P2 trial • CNS Disorders • Oncology • Pain • Peripheral Neuropathic Pain

AlgoTherapeutix Completes Phase I for Peripheral Neuropathy Program ATX01, Poised for Phase II Initiation in 2022 (Businesswire) - "France-based biotechnology company AlgoTherapeutix, 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)."

New P2 trial • Trial completion • Pain • Peripheral Neuropathic Pain

"AlgoTherapeutix Completes Phase I for Peripheral Neuropathy Program ATX01, Poised for Phase II Initiation in 2022 https://t.co/lQAvULF1ho" (@NewsFromBW)

CNS Disorders • Pain • Peripheral Neuropathic Pain