laflunimus (AP-325) / Algiax - LARVOL DELTA

Algiax Announces Positive Data from Phase 2a Proof of Concept Study Evaluating AP-325 in Patients with Neuropathic Pain (GlobeNewswire) - P2a | N=99 | NCT04429919 | Sponsor: Algiax Pharmaceuticals GmbH | "Rapid onset of action resulting in clinically meaningful pain reduction in Pain Intensity Numeric Rating Scale (PI-NRS) within less than two weeks of treatment; Treatment effects remained persistent after initial treatment period, suggesting a potential lasting disease modification; High responder rate: the ≥50% and ≥70% patient responder rates were significantly higher compared to placebo with AP-325 treatment. At the end of study, over a quarter of the AP-325 treated patients showed a pain reduction of ≥50% compared to 11% of the placebo treated patients; More than half of patients in the AP-325 cohort did not need to use rescue medication compared to only 21% in the placebo group; Number needed to treat (NNT) for AP-325...compares favourably to current standard of care demonstrates AP-325 achieves similar outcomes as opioid-based drugs without the associated safety concerns"

P2a data • CNS Disorders • Pain

Effects of GABAA Receptor Modulation by AP-325 on Insulin Secretion in Patients with Type 2 Diabetes (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: The Deutsche Diabetes Forschungsgesellschaft e.V. | Recruiting ➔ Completed | Trial completion date: Jun 2025 ➔ Dec 2024

Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2 | N=99 | Completed | Sponsor: Algiax Pharmaceuticals GmbH | Recruiting ➔ Completed | Trial completion date: Mar 2025 ➔ Oct 2024

Trial completion • Trial completion date • Neuralgia • Pain

Effects of GABAA Receptor Modulation by AP-325 on Insulin Secretion in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: The Deutsche Diabetes Forschungsgesellschaft e.V. | Trial primary completion date: Jun 2024 ➔ Jan 2025

Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Algiax Pharmaceuticals GmbH | Trial completion date: Jun 2024 ➔ Mar 2025 | Trial primary completion date: Apr 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • Neuralgia • Pain

Algiax Pharmaceuticals Expands Phase 2a Study with Lead Candidate AP-325 in Chronic Neuropathic Pain with 12 New Clinical Sites in Belgium and France (PRNewswire) - "Algiax Pharmaceuticals, today provided an update on its ongoing Phase 2a study (NCT04429919) with lead candidate AP-325 in patients with chronic neuropathic pain...Based on last year's positive mid-enrollment interim analysis and confirmed financial commitment from its investors, the company is pleased to announce the initiation of 12 new clinical sites in Belgium and France as part of its Phase 2a Randomized Controlled Trial (RCT) - AP-325.04 study. With these additions, the total number of active sites in the study has reached 25, including sites in the Czech Republic and Spain...In Belgium, our study has successfully enrolled patients with chronic post-operative neuropathic pain at the sites of Dr. van Boxem at ZOL in Genk and Prof. Morlion at UZ Leuven....'The addition of these new clinical sites further strengthens our efforts to present topline efficacy readouts and an in-depth safety analysis following study conclusion in Q4 2024.'"

P2a data • Trial status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Effects of GABAA Receptor Modulation by AP-325 on Insulin Secretion in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=38 | Recruiting | Sponsor: The Deutsche Diabetes Forschungsgesellschaft e.V. | Trial completion date: Sep 2022 ➔ Jun 2025 | Trial primary completion date: Jun 2022 ➔ Jun 2024

Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Algiax Pharmaceuticals GmbH

Trial completion date • Trial primary completion date • Neuralgia • Pain

Algiax Pharmaceuticals Announces Positive Interim Analysis of Phase 2a Study with Lead Candidate AP-325 in Chronic Neuropathic Pain (Businesswire) - "Algiax Pharmaceuticals, today provided an update on its ongoing Phase 2a study...with lead candidate AP-325 in patients with chronic neuropathic pain. As part of a planned mid-enrollment interim analysis, the independent Data Monitoring Committee (DMC) recommended the continuation of the study and confirmed the absence of safety issues among the study participants. Based on the positive DMC review and confirmed financial commitment from its investors, the company will expand the trial to Belgium, France, and Italy. The study is continuing as planned with topline efficacy readouts and a more in-depth safety analysis expected at the conclusion in 2024."

DSMB • P2 data • Trial status • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Algiax Pharmaceuticals GmbH | Trial completion date: Apr 2023 ➔ Jun 2024 | Trial primary completion date: Feb 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Neuralgia • Pain • CYP2C9

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2; N=96; Recruiting; Sponsor: Algiax Pharmaceuticals GmbH; Trial completion date: Feb 2022 ➔ Apr 2023; Trial primary completion date: Dec 2021 ➔ Feb 2023

Trial completion date • Trial primary completion date • Neuralgia • Pain • CYP2C9

Effects of GABAA Receptor Modulation by AP-325 on Insulin Secretion in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2; N=38; Recruiting; Sponsor: The Deutsche Diabetes Forschungsgesellschaft e.V.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effects of GABAA Receptor Modulation by AP-325 on Insulin Secretion in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2; N=38; Not yet recruiting; Sponsor: The Deutsche Diabetes Forschungsgesellschaft e.V.

Clinical • New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2; N=94; Recruiting; Sponsor: Algiax Pharmaceuticals GmbH; Trial completion date: Oct 2021 ➔ Feb 2022; Trial primary completion date: Aug 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Neuralgia • Pain • Peripheral Neuropathic Pain • CYP2C9

Algiax Pharmaceuticals Announces First Patient Enrolled in Phase IIa Multi-center Proof-of-Concept Study Evaluating AP-325 in Chronic Neuropathic Pain (PipelineReview) - "Algiax Pharmaceuticals...announced that the first patient has been enrolled in the 'CURE' study. Top-line Data for the 'CURE' Study Anticipated in Fourth Quarter 2021....The CURE study is a randomized, double-blind, placebo controlled, parallel group study to evaluate the efficacy and safety after repeated oral dosing of Algiax´ lead product AP-325. The subjects had previously been diagnosed with peripheral post-surgical neuropathic pain (PPNP) after breast surgery, chest surgery or groin hernia repair. The aim is to enroll 94 subjects in 13 participating clinical sites in Germany, Spain and the Czech Republic."

Enrollment status • P2a data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2; N=94; Recruiting; Sponsor: Algiax Pharmaceuticals GmbH; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Neuralgia • Pain • CYP2C9

AP-325 in Subjects With Peripheral Post-surgical Neuropathic Pain (clinicaltrials.gov) - P2; N=94; Not yet recruiting; Sponsor: Algiax Pharmaceuticals GmbH

Clinical • New P2 trial • Breast Cancer • Neuralgia • Pain • Solid Tumor

Phase 2 study to evaluate the efficacy and safety of a ten-days treament of subjects with peripheral post-surgical neuropathic pain with drug AP-325 or placebo Estudio de fase 2 para evaluar la eficacia y seguridad de un tratamiento de diez días con el medicamento AP-325 o placebo en pacientes con dolor neuropático periférico post-quirúrgico (clinicaltrialsregister.eu) - P2; N=94; Ongoing; Sponsor: Algiax Pharmaceuticals GmbH

New P2 trial

Algiax is ready to go into proof-of-concept for AP-325 and welcomes new investors (Businesswire) - "Algiax Pharmaceuticals...announced to have secured financing for its development program including a proof-of-concept Phase IIa study named 'CURE' for its lead compound AP-325 in chronic neuropathic pain....The company further announced that it has filed a clinical trial application for its phase IIa clinical trial 'CURE' in the EU and plans to start patient recruitment in beginning of 2020."

Enrollment open • European regulatory • Financing

"Algiax Is Ready to Go Into Proof-of-Concept for AP-325 and Welcomes New Investors https://t.co/Sl67IdOmAX" (@NewsFromBW)