ACD440 / AlzeCure - LARVOL DELTA

The TRPV1 antagonist ACD440 Gel as a tool in pain precision medicine, results of a post hoc analysis (NeuPSIG 2025) - "The overall effect suggests that ACD440 Gel may be effective in reducing pain where TRPV1 receptor mechanisms are important in the initiation or maintenance of pain. These results demonstrate a Proof of mechanism in the treatment of heat hyperalgesia. This type of precision medicine for burning pain may become a treatment option for patients with burning pain is a major component of their overall pain (Alpes).Considering the significant period effect seen in this study, this may be seen as a limitation."

Retrospective data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • TRPV1

AlzeCure to present promising pain therapy ACD440 at NeuPSIG 2025 (PharmaTimes) - P2a | N=14 | NCT05416931 | Sponsor: AlzeCure Pharma | "AlzeCure Pharma will present new clinical data for its drug candidate ACD440 at NeuPSIG 2025, a global pain conference taking place in Berlin from 4 to 6 September...The abstract was accepted for presentation and will be delivered by Dr Märta Segerdal, Head of Development and CMO...ACD440 is a topical gel formulation targeting peripheral neuropathic pain. The substance, a TRPV1 antagonist, shows powerful effects especially against heat-induced pain, according to post hoc analysis from the phase 2a study. This aligns with its mechanism of action....'The positive results from the phase 2 study demonstrate both significant efficacy and good tolerability and support the continued development of ACD440.'"

P2a data • Pain • Peripheral Neuropathic Pain

AlzeCure's Pain Project ACD440 Granted Orphan Drug Status in the US by the FDA (PharmiWeb) - "AlzeCure Pharma...announced that the US Food and Drug Administration (FDA) has granted the company's application for orphan drug status for the clinical pain candidate drug ACD440."

Orphan drug • Pain • Peripheral Neuropathic Pain

Topically applied novel TRPV1 receptor antagonist, ACD440 Gel, reduces temperature-evoked pain in patients with peripheral neuropathic pain with sensory hypersensitivity, a randomized, double-blind, placebo-controlled, crossover study. (PubMed, Scand J Pain) - "ACD440 Gel demonstrated a significant analgesic effect on thermally evoked pain, especially in suprathreshold heat pain. This is congruent with an attenuation of thermal hyperalgesia in chronic neuropathic pain patients with C-fibre mediated pain, while there was no effect on evoked pain related to Aβ and Aδ stimuli. The results support further clinical development in patients with thermally induced C-fibre mediated pain."

Clinical • Journal • Immunology • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure Carries out a Rights Issue of Approximately SEK 48.5 million (ACCESSWIRE) - "AlzeCure Pharma...announces that the Board of Directors has resolved on a new share issue of approximately SEK 48.5[1] million with preferential rights for existing shareholders (the 'Rights Issue')...'The proceeds will be used to prepare for the upcoming Phase 2 study with ACD856 in Alzheimer's patients, which is also co-financed by the European Innovation Council (EIC). In addition to the EUR 2.5 million grant from EIC, we have also received an offer for further potential funding through an EIC equity investment in AlzeCure, which we are currently evaluating. The proceeds will also support continued business development efforts, with a focus on out-licensing ACD440 following the positive feedback from the FDA regarding a Phase 2b/3 registration study, which adds value for our shareholders.'"

Financing • Alzheimer's Disease • Pain • Peripheral Neuropathic Pain

New Scientific Article Published on Positive Clinical Results with Painless ACD440 Against Neuropathic Pain (Yahoo Finance) - P1 | N=24 | NCT04704232 | Sponsor: AlzeCure Pharma | "AlzeCure Pharma AB...today announced that a scientific article has been published on the clinical phase Ib results that support the continued development of the lead drug candidate Painless ACD440....The article focuses on the clinical phase Ib study with ACD440. The results show that ACD440 had significant analgesic effects of laser-induced pain compared to placebo both when the individual was asked to rate their pain experience and when pain-related brain activity was measured. Furthermore, significant effects on mechanical pain sensitivity were also observed. The results also showed that the analgesic effects lasted for at least 9 hours and that the product was very well tolerated as a topical gel on the skin, which indicates good suitability for further clinical development, i.e. as a local treatment against nociceptive and neuropathic pain conditions."

P1 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Topically applied novel TRPV1 receptor antagonist, ACD440 Gel, reduces evoked pain in healthy volunteers, a randomized, double-blind, placebo-controlled, crossover study. (PubMed, Eur J Pain) - "This study demonstrates that the topical administration of a TRPV1-antagonist, ACD440 Gel, has potential as a new treatment for painful conditions affecting the skin, such as chronic peripheral neuropathic pain, without any local or systemic side effects."

Clinical • Journal • Dermatology • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure presents clinical phase II-data with ACD440 for neuropathic pain at pain conference (AlzeCure Pharma Press Release) - P2a | N=14 | NCT05416931 | Sponsor: AlzeCure Pharma |"AlzeCure Pharma AB...today announced that the company’s presentation at the pain conference held by the Swedish Pain Society is now available in its entirety on the company's website. The presentation contains clinical data from the phase II study with the company's leading drug candidate in pain, ACD440, which is being developed for the treatment of peripheral neuropathic pain....The results showed that after 7 days of treatment with ACD440, the temperature-triggered pain was reduced by about 50%, a significant and clinically relevant effect. No treatment-related side effects were reported, indicating that the product is safe and well tolerated by patients."

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

AlzeCure Gets an Abstract on Phase II Clinical Data with ACD440 for Neuropathic Pain Accepted at Pain Conference (BioSpace) - P2a | N=14 | NCT05416931 | Sponsor: AlzeCure Pharma | "AlzeCure Pharma AB...announced that an abstract on ACD440, the leading non-opioid drug candidate in the Painless platform, has been accepted for presentation at the annual pain conference to be held by the Swedish Pain Society in Uppsala, Sweden, on October 12-13....The presentation will include results from the completed phase II clinical trial of ACD440 in patients with peripheral neuropathic pain....'The study results showed a significant positive effect of ACD440 on temperature-triggered pain, which confirms our previous phase Ib study with the substance. These promising data together with the very good tolerability observed in patients further strengthen our hypotheses and bode well for the continued clinical development of ACD440...'"

P2 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure presents positive phase II clinical data with ACD440 against neuropathic pain at EFIC 2023 Conference (BioSpace) - P2a | N=14 | NCT05416931 | Sponsor: AlzeCure Pharma | "AlzeCure Pharma...today announced that the company's presentation at the pain conference EFIC 2023 is now available in its entirety on the company's website. The presentation contains clinical phase II data with the company's leading clinical candidate drug in pain, Painless ACD440, which is being developed with a focus on neuropathic pain....The majority of them also were on existing pain treatment. Data from the study showed a clear and significant effect (p=0.0166) of ACD440 gel on temperature-induced pain in the patients. A very good safety and tolerability of the product in the patients was also observed."

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

AlzeCure presents at Aktiespararna’s Small Business Days on June 13 (Market Screener) - "AlzeCure Pharma AB...today announced that the company will participate at Småbolagsdagarna in Stockholm, Sweden, on June 13 at 14:20 CET. CEO Martin Jonsson will present the latest development of the company, including the recently presented positive phase II results with ACD440 in neuropathic pain."

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

Last Patient Included in Alzecure’s Phase II Clinical Trial in Peripheral Neuropathic Pain with The Non-Opioid ACD440 (BioSpace) - "AlzeCure Pharma...today announced that the last patient has now been included in the ongoing Phase II clinical study with ACD440, the lead non-opioid drug candidate in the Painless platform, which is being developed against peripheral neuropathic pain....This double-blind, placebo-controlled, randomized cross-over study, which is carried out in collaboration with LINK Medical Research in Uppsala, is aimed at evaluating the efficacy, safety and pharmacokinetics of AlzeCure's lead drug candidate in pain, ACD440. The main results from the study are expected by the summer of 2023 at the latest."

Enrollment closed • P2 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure Announces Positive Phase IIa Clinical Study Data in Neuropathic Pain with the Non-opioid ACD440 (Issuer Direct) - P2a | N=14 | NCT05416931 | Sponsor: AlzeCure Pharma | "AlzeCure Pharma...announced that the company has received positive data from the Phase IIa clinical study with the non-opioid drug candidate ACD440, which is developed against peripheral neuropathic pain. The phase II data show that ACD440 was able to demonstrate positive proof-of-mechanism (PoM) results in patients with chronic peripheral neuropathic pain, i.e. the drug candidate has an effect on the intended target mechanism. A significant analgesic effect was observed on pain induced by cold and heat. This temperature hypersensitivity is very common in the skin area, where the patients have their neuropathic pain, and is a major problem in everyday life for these individuals."

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

AlzeCure Gets an Abstract on Non-Opioid ACD440 for Neuropathic Pain Accepted at the EFIC 2023 Conference (BioSpace) - "AlzeCure Pharma AB...today announced that an abstract on ACD440, the leading non-opioid drug candidate in the Painless platform, has been accepted for presentation at the annual international pain conference EFIC, European Pain Federation, which this year is being held in Budapest, Hungary, on September 20-22....The presentation will include results from the ongoing phase II clinical trial of ACD440 in patients with peripheral neuropathic pain....The main results from the study are expected by the summer of 2023 at the latest."

P2 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

ACD440 Gel in Peripheral Neuropathic Pain (clinicaltrials.gov) - P2a | N=14 | Completed | Sponsor: AlzeCure Pharma | Recruiting ➔ Completed

Trial completion • Immunology • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure Achieves Last Patient Last Visit (LPLV) in its Phase II Clinical Trial of the Non-Opioid ACD440 in Neuropathic Pain (BioSpace) - "AlzeCure Pharma AB...today announced that the Last Patient Last Visit (LPLV) has now been completed in the ongoing phase II clinical trial with ACD440, the lead non-opioid drug candidate in the Painless platform, which is being developed against peripheral neuropathic pain....The main results from the study are expected by the summer of 2023 at the latest."

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

ACD440 Gel in Peripheral Neuropathic Pain (clinicaltrials.gov) - P2a | N=14 | Recruiting | Sponsor: AlzeCure Pharma | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Neuralgia • Pain • Peripheral Neuropathic Pain

First Patient Included in AlzeCure's Phase II Clinical Trial in Neuropathic Pain with Non-opioid ACD440 (BioSpace) - "AlzeCure Pharma AB...announced that the first patient has been included in a Phase II clinical trial with ACD440, the leading non-opioid drug candidate in the Painless platform which is being developed for peripheral neuropathic pain. This follows the recent approvals from regulatory authorities to begin the study. The Phase II clinical trial is a double-blind, placebo-controlled, randomized cross-over study evaluating the efficacy, safety, and pharmacokinetics of AlzeCure's leading drug candidate in pain, ACD440. Results from the study are expected in mid-2023."

Enrollment open • P2 data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

ACD440 Gel in Peripheral Neuropathic Pain (clinicaltrials.gov) - P2a | N=14 | Not yet recruiting | Sponsor: AlzeCure Pharma

New P2a trial • Immunology • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure gets Approval to Start Phase II Clinical Trial with Non-opioid Pain Project ACD440 (BioSpace) - "AlzeCure Pharma...today announced that it has received approval from the regulatory authorities in Sweden to initiate its clinical phase IIa study with the drug candidate ACD440 in patients with peripheral neuropathic pain...The aim of the study is to evaluate the analgesic effects of the drug candidate in patients with peripheral neuropathic pain, but also its tolerability after repeated dosing....'We expect to be able to initiate the study soon and present results in 2023'..."

New P2a trial • P2a data • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure carries out a set-off issue in connection with ACD440 entering phase II and Acturum Life investing in the company (PharmiWeb) - "AlzeCure Pharma AB...announces today that the company is carrying out a set-off issue of 845,070 shares to Acturum Life AB as a result of a previously agreed milestone payment, which will be made in the form of shares instead of cash payment. In connection with ACD440, a drug candidate focused on the treatment of peripheral neuropathic pain, soon will initiate its planned phase IIa study, AlzeCure Pharma will, in accordance with previous agreements, pay a milestone payment to the previous owner Acturum Life AB. According to a new supplementary agreement between the parties, Acturum Life will receive shares in AlzeCure Pharma instead of cash payment and this will take the form of a set-off issue."

Commercial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure Publishes its Year-End Report for 2021 (Yahoo News) - "AlzeCure Pharma AB...today announced that its Year-end report for 2021....The company has received indicative answers from the FDA that support the continued development program for ACD440, as well as the preparatory work for the upcoming clinical phase II study."

FDA event • New P2 trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

AlzeCure is Moving Towards Phase IIa Clinical Trial with ACD440 Based on Guiding Response from the FDA (BioSpace) - "AlzeCure Pharma AB...today announced that it has received a response from the US Food and Drug Administration (FDA) regarding the preIND application that was submitted prior to the planned phase IIa study with ACD440 in neuropathic pain."

FDA event • New P2a trial • CNS Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain

Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: AlzeCure Pharma; Recruiting ➔ Completed

Clinical • Trial completion • Pain

[VIRTUAL] ACD440 – A Novel TRPV1 Antagonist for the Topical Treatment of Pain (IASP 2021) - "Topical administration of ACD440 was safe and tolerable. Conclusions regarding pharmacodynamic effects will be presented in the conference poster."

Acne Vulgaris • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Mood Disorders • Neuralgia • Novel Coronavirus Disease • Pain • Peripheral Neuropathic Pain • Pruritus • Rosacea • CD44