ACD856 / AlzeCure, QuantumCell - LARVOL DELTA

AlzeCure receives a total upfront payment of USD 12 million and completes the initial transaction with QuantumCell (TradingView) - "The payment is made pursuant to the licensing and collaboration agreement for the NeuroRestore Alzheimer’s platform, including the lead drug candidate ACD856, entered on July 1, 2026. With the payment, all conditions for completion of the transaction have been fulfilled, and the initial transaction has been completed....The transaction has been completed following the satisfaction of customary closing conditions, including approval by the Swedish and Danish authorities under the applicable foreign direct investment regulations."

Financing • Alzheimer's Disease

AlzeCure Pharma Enters an Out-Licensing and Collaboration Agreement with QuantumCell ApS for the NeuroRestore ACD856 Project (Yahoo Finance) - "AlzeCure will receive an total upfront payment of USD 12 million, of which USD 5 million constitutes a direct investment in AlzeCure, at a 30% premium to the average share price of SEK 3.78 for the last 10 trading days. Furthermore, the agreement contains set development and commercial milestone payments, as well as tiered single-digit to low double-digit royalties on sales. The total deal value, excluding royalty payments, exceeds USD 2.2 billion."

Licensing / partnership • Alzheimer's Disease

Positive Results From The Phase Ib Clinical Study of NeuroRestore ACD856, Under Development for Alzheimer's (ACCESS Newswire) - "'Consistent with previous clinical data, the results show that ACD856 was well-tolerated and no substance-related safety findings were observed. Furthermore, an expected increase in the concentration of ACD856 was seen in both blood and cerebrospinal fluid. These data further strengthen the continued development of ACD856, broaden the therapeutic window, and provide a solid foundation for dose selection in future clinical studies.'....ACD856 is a first-in-class drug candidate for Alzheimer's disease and is currently being prepared for upcoming Phase II clinical studies in patients; it was also awarded a major EU grant from the European Innovation Council (EIC) in 2025. This study is expected to start in 2026."

New P2 trial • P1 data • Alzheimer's Disease • Depression

Last patient has completed AlzeCure’s Phase Ib clinical study with NeuroRestore ACD856 (AlzeCure Pharma Press Release) - "The Phase Ib clinical study aims to evaluate the safety and tolerability of ACD856 following repeated administration of higher doses, while also assessing the substance's concentration in the body....ACD856 is a first-in-class drug candidate for Alzheimer’s disease and is currently being prepared for upcoming Phase II clinical trials."

New P2 trial • Trial completion • Alzheimer's Disease

A randomised, double-blind, placebo-controlled phase Ib trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ACD856 in healthy participants (clinicaltrialsregister.eu) - P1 | N=40 | Completed | Sponsor: AlzeCure Pharma AB | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

AlzeCure Pharma to Present at Redeye Alzheimer's Theme Event on April 9 (Yahoo Finance) - "...CEO Martin Jönsson and CSO Johan Sandin will present the company and its project portfolio within Alzheimer's. The presentation will be followed by a Q&A session moderated by Redeye's analysts."

Clinical • Alzheimer's Disease

CHARACTERIZATION OF MECHANISMS OF ACTION OF NEURORESTORE ACD856, A POSITIVE ALLOSTERIC MODULATOR OF TRK-RECEPTORS UNDER CLINICAL DEVELOPMENT FOR ALZHEIMER'S DISEASE. (ADPD 2026) - "ACD856, a novel small-molecule Trk-PAM in clinical development with symptomatic and disease-modifying properties, leads to Trk-dependent phosphorylation, dose- and time-dependent effects on downstream signaling pathways, and exposure-dependent efficacy."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • NTRK2 • STAT3

AlzeCure Presents New Preclinical Data with NeuroRestore ACD856 at the Alzheimer's Conference AD/PD (ACCESS Newswire) - "The results of the preclinical studies showed that ACD856 induces a dose-dependent activation of Trk receptors and downstream target proteins in line with the proposed targeting mechanism. These findings could be verified in vivo after ACD856 treatment, where a potent antidepressant effect was also observed in line with previously reported data. Taken together, the findings indicate that ACD856 mediates its effects via Trk receptors, which enhances the effect of neurotrophins such as NGF and BDNF...ACD856 is a first-in-class drug candidate for Alzheimer's disease and is now being prepared for upcoming Phase II clinical trials in patients..."

New P2 trial • Preclinical • Alzheimer's Disease

A randomised, double-blind, placebo-controlled phase Ib trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ACD856 in healthy participants (clinicaltrialsregister.eu) - P1 | N=40 | Recruiting | Sponsor: AlzeCure Pharma AB

New P1 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Mood Disorders • Psychiatry

AlzeCure Pharma AB…announced that an abstract with preclinical data on NeuroRestore ACD856 which examines in more detail the biological effects of the substance mediated by its mechanism of action has been accepted for presentation at the international conference AD/PD 2026 (ACCESS Newswire) - "The presentation includes new preclinical results demonstrating that ACD856, the lead drug candidate within the NeuroRestore platform, affects Trk receptor-mediated signaling pathways in a dose- and time-dependent manner. Data also demonstrate that ACD856 exhibits potent and significant positive effects on cognition and depression."

Preclinical • Alzheimer's Disease • Cognitive Disorders • Depression

AlzeCure Pharma…announced today that the company has received the first payment of a grant of EUR 2.5 million from the European Innovation Council (EIC) (ACCESS Newswire) - "The grant from the EIC Accelerator will help AlzeCure to conduct important clinical trials where NeuroRestore ACD856 will be tested in patients with Alzheimer's disease."

Financing • Alzheimer's Disease

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

FURTHER INVESTIGATION ON THE IMMUNOMODULATORY AND ANTI -INFLAMMATORY EFFECTS OF NEURORESTORE ACD856, A TRK -PAM IN CLINICAL DEVELOPMENT FOR THE TREATMENT OF ALZHEIMER'S DISEASE (ADPD 2025) - "Consistent with the anti -inflammatory effects of ACD856 in old and APPNLGF mouse models, we found that ACD856 significantly reduced the release of IL -6 in BV2 cells after LPS -induced inflammation suggesting that ACD856 may modulate brain immune cells and possibly delaying neurodegeneration in neuroinflammatory diseases like AD."

Clinical • Immunomodulating • Alzheimer's Disease • CNS Disorders • Inflammation • BDNF • IL6

AlzeCure Receives EU Grant for Phase 2 Clinical Trial of NeuroRestore ACD856 for Alzheimer's Disease (ACCESSWIRE) - "AlzeCure Pharma AB (publ)...announced that its project NeuroRestore ACD856 has received €2.5m from the EU's European Innovation Council. This funding will support AlzeCure's planned Phase IIa study of NeuroRestore ACD856 in Alzheimer's patients. In addition, higher doses of ACD856 will be evaluated in humans, as the good safety profile allows for further dosing. ACD856 has the potential to be the first drug in a new category of Alzheimer's drugs - positive allosteric modulators of Trk receptors (Trk-PAMs), which increase BDNF and NGF signaling."

Financing • Alzheimer's Disease

AlzeCure Receives Abstract Acceptance at Alzheimer’s Congress AD/PD 2025 on NeuroRestore ACD856 (ACCESSWIRE) - "AlzeCure Pharma...announced that an abstract with preclinical data on NeuroRestore ACD856 demonstrating its anti-inflammatory and immunomodulatory effects has been accepted for presentation at the international conference AD/PD 2025, which will be held this year in Vienna on April 1-5....The presentation includes preclinical study results showing that ACD856, the lead drug candidate within the NeuroRestore platform, affects biomarkers relevant to the pathological neuroinflammatory processes in Alzheimer's disease. These new data further point to the potential disease-modifying effect of the NeuroRestore compound."

Preclinical • Alzheimer's Disease

AlzeCure Pharma to Present at Stora Aktiedagarna in Stockholm (Yahoo Finance) - "AlzeCure Pharma AB...today announced that the company's CEO Martin Jönsson will present at Stora Aktiedagarna in Stockholm...During the day, Martin Jönsson will present the company's project portfolio and drug candidates within the three research platforms NeuroRestore, Alzstatin and Painless, including the lead candidate ACD856, which is being prepared for clinical phase 2 studies."

Clinical data • Alzheimer's Disease • CNS Disorders

Preclinical evidence for anti-inflammatory and immunomodulatory effects of NeuroRestore ACD856, a Trk-PAM in clinical development for the treatment of Alzheimer's disease (CTAD 2024) - No abstract available

Immunomodulating • Late-breaking abstract • Preclinical • Alzheimer's Disease • CNS Disorders

AlzeCure's Abstract on ACD856's Anti-inflammatory Effects to be Presented at a Leading Alzheimer's Conference (ACCESSWIRE) - "AlzeCure Pharma...announced that an abstract with preclinical data on NeuroRestore ACD856 demonstrating its anti-inflammatory and immunomodulatory effects has been accepted for presentation at the annual Alzheimer's conference CTAD, Clinical Trials in Alzheimer's Disease, which this year is being held in Madrid, Spain, on October 29 - November 1....The presentation includes new preclinical results with ACD856, the lead clinical drug candidate within the NeuroRestore platform. The data show that the substance shows both anti-inflammatory and immunomodulating properties, something that has been demonstrated after treatment in both aged animals and in Alzheimer's models. This indicates potentially disease-modifying properties of this class of molecules."

Preclinical • Alzheimer's Disease

Positive Allosteric Modulators of Trk Receptors for the Treatment of Alzheimer's Disease. (PubMed, Pharmaceuticals (Basel)) - "Two examples of successful discovery and development of PAMs are the TrkA-PAM E2511 and the pan-Trk PAM ACD856. This review aims to present the concept of positive allosteric modulators of the Trk receptors as a novel future treatment option for Alzheimer's disease and other neurodegenerative and cognitive disorders, and the current preclinical and clinical data supporting this new concept. Preclinical data indicate dual mechanisms, not only as cognitive enhancers, but also a tentative neurorestorative function."

Journal • Review • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Developmental Disorders

AlzeCure Reports Anti-Inflammatory Effects with NeuroRestore ACD856 with Relevance to Alzheimer's Leading to New Patent Application (ACCESSWIRE) - "AlzeCure Pharma...announced that the company has received preclinical data for NeuroRestore in inflammation, with relevance to Alzheimer's disease, and submitted a new patent application for NeuroRestore ACD856, which is now being prepared for phase II clinical studies....New preclinical data show that the NeuroRestore substance ACD856 exhibits anti-inflammatory properties both centrally in the brain and peripherally in the body with relief of clinical inflammatory symptoms in preclinical models and a reduction in several inflammatory markers. These new data indicate an opportunity to treat diseases with elements of neuroinflammation, such as Alzheimer's disease, and that ACD856 can have a disease-modifying effect via its anti-inflammatory properties."

Patent • Preclinical • Alzheimer's Disease

AlzeCure Publishes Clinical Results Supporting Continued Development of NeuroRestore ACD856 Against Alzheimer's (Yahoo Finance) - P1 | N=56 | NCT05077631 | Sponsor: AlzeCure Pharma | "AlzeCure Pharma...today announced that another scientific article has been published on the phase I clinical results supporting the continued development of the lead drug candidate NeuroRestore ACD856....The article focuses on the results from the clinical phase I study (Single Ascending Dose, SAD) with ACD85...but also contains data from the previously performed microdose study in humans. The results of this study, which was the first clinical study of ACD856, demonstrated that the compound had suitable pharmacokinetic properties with a half-life in humans that allows for once-daily dosing. The subsequent SAD study was able to confirm the good pharmacokinetic properties with rapid absorption in the body and a linear increase in the concentration of the substance in the blood with increased oral dosage."

P1 data • Alzheimer's Disease • CNS Disorders

AlzeCure's Alzheimer's Project NeuroRestore ACD856 is Granted an Additional Patent (ACCESSWIRE) - "AlzeCure Pharma...announced that the patent offices in China, India, South Africa, Israel, Hong Kong and Mexico have granted patents covering the company's clinical drug candidate ACD856, which is being developed against Alzheimer's and other disorders with cognitive impairment....The company's patent application for ACD856 has now also been granted in China, India, South Africa, Israel, Hong Kong and Mexico. The patent numbers are ZL2019800147986, IN432151, ZA2020/04220, IL276624, HK40033844 and MX402512, respectively, and the patents are expected to provide protection until 2039. Previously, ACD856 has been granted patent protection in the USA, Japan and Europe."

Patent • Alzheimer's Disease

ACD856 IS A BIASED POSITIVE ALLOSTERIC MODULATOR OF TRK-RECEPTORS - ENHANCES NEURITE OUTGROWTH BUT DO NOT AFFECT PAIN SIGNALING (ADPD 2024) - "The results indicate that while ACD856 can enhance neurite outgrowth, it does not induce or aggravate NGF-induced heat allodynia. These findings indicate that the compound acts as a biased Trk-PAM with the advantages of neurotrophic support and cognitive enhancing effects of neurotrophins, but without pain inducing effects. This differential activation pattern of downstream signalling pathways would provide for a significantly improved therapeutic and tolerability profile for this novel class of compounds."

Alzheimer's Disease • CNS Disorders • Pain

ACD856, a novel positive allosteric modulator of Trk receptors, single ascending doses in healthy subjects: Safety and pharmacokinetics. (PubMed, Eur J Clin Pharmacol) - P1 | "The prediction proved accurate demonstrating the value of conducting a microdose study prior to ascending dose studies."

Journal • PK/PD data • Alzheimer's Disease • CNS Disorders • Depression • Psychiatry

AlzeCure Gets Late Breaking Abstract of New Preclinical Data with ACD856 Accepted at AD/PD 2024 Conference (ACCESSWIRE) - "AlzeCure Pharma...announced that an abstract on preclinical data with its lead drug candidate NeuroRestore ACD856 has been accepted for a poster presentation at AD/PD 2024, which will be held in Lisbon on March 5-9....The presentation includes study results showing that ACD856, the lead drug candidate in the NeuroRestore platform being developed with a focus on Alzheimer's disease, selectively appears to potentiate some signaling pathways, but not others. New preclinical data show that the substance stimulates the growth of nerve cell projections, which can promote nerve cell communication, but does not affect other functions, such as pain signaling."

Late-breaking abstract • Preclinical • Alzheimer's Disease