ACD856 / AlzeCure - LARVOL DELTA

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

NeuroRestore ACD856, a Trk-PAM in clinical development for Alzheimer's disease shows neuroprotective and neurorestorative effects (CTAD 2023) - "We established that NeuroRestore ACD856 had neurotrophic effects, stimulating neurite outgrowth and increasing SNAP25 levels in PC12 cells. Additionally, it displayed neuroprotective effects, significantly decreasing Aβ1-42-induced toxicity. ACD856 was also able to increase levels of BDNF in vitro and in vivo suggesting effects that are long lived due to the function and role of BDNF on surrounding tissues."

Clinical • Alzheimer's Disease • CNS Disorders • Aβ42 • BDNF • NTF3 • NTRK2 • NTRK3

Safety, Tolerability, Pharmacokinetics and Quantitative Electroencephalography Assessment of ACD856, a Novel Positive Allosteric Modulator of Trk-Receptors Following Multiple Doses in Healthy Subjects. (PubMed, J Prev Alzheimers Dis) - "ACD856 was well tolerated at the tested dose levels (10-90 mg/daily for 7 days) in healthy subjects. The compound has a robust pharmacokinetic profile, with rapid absorption and dose-dependent exposure. ACD856 was shown to pass the blood-brain-barrier, reach relevant exposure in the CNS and to induce dose-dependent treatment-related changes on qEEG parameters, indicating central target engagement."

Journal • PK/PD data • Alzheimer's Disease • CNS Disorders • Depression • Mental Retardation • Mood Disorders • Psychiatry • Suicidal Ideation

AlzeCure Presents Disease-Modifying Data with NeuroRestore ACD856 at Alzheimer's Conference CTAD (BioSpace) - "AlzeCure Pharma...today announced that the company's presentation at the Alzheimer's conference CTAD 2023 is now available in its entirety on the company's website. The presentation contains new preclinical data with its leading clinical drug candidate NeuroRestore ACD856, which is being developed with a focus on Alzheimer's disease....The results from the new preclinical studies with ACD856 show, among other things, that the substance can protect nerve cells against toxic Ab42, the protein that forms amyloid plaques in the brains of Alzheimer's patients. Furthermore, growth-stimulating effects on neurons were observed with ACD856. These effects have specific relevance to Alzheimer's disease, where dysfunction and loss of neurons are important key findings in the disease."

Preclinical • Alzheimer's Disease • CNS Disorders

AlzeCure's Alzheimer Project NeuroRestore ACD856 is also Granted a Patent in Japan (BioSpace) - "AlzeCure Pharma AB...today that the Japenese Patent Office (JPO) has granted a patent covering the company's leading candidate drug ACD856, from the NeuroRestore platform, which is developed against Alzheimer's disease and other disorders with cognitive impairment....The company's patent application for ACD856 in Japan has been granted by the JPO. The patent number is 7350759 and the patent is expected to provide protection until 2039."

Patent • Alzheimer's Disease

AlzeCure gets Presentation Accepted on Disease-Modifying Effects of ACD856 at Alzheimer’s Conference (BioSpace) - "AlzeCure Pharma...today announced that an abstract with preclinical data on NeuroRestore ACD856 demonstrating its potential disease-modifying 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 Boston on October 24-27....The presentation includes new preclinical results with ACD856, the lead candidate drug within the NeuroRestore platform. The data show that the substance exhibits both protective and regenerative effects on nerve cells, indicating potentially disease-modifying properties of this class of molecules."

Preclinical • Alzheimer's Disease • CNS Disorders

AlzeCure Publishes the Positive Clinical Results from the Phase I Trial of NeuroRestore ACD856 Against Alzheimer's (BioSpace) - P1 | N=24 | NCT05077501 | Sponsor: AlzeCure Pharma | "AlzeCure Pharma AB...today announced that a new scientific article has been published on the Phase I clinical results supporting the continued development of the lead candidate drug NeuroRestore ACD856. The article...was published in The Journal of Prevention of Alzheimer's Disease....The article focuses on the results from the clinical phase I study (Multiple Ascending Dose, MAD) which shows that ACD856, the primary drug candidate within the company's NeuroRestore platform, has good tolerability and safety. Furthermore, it was observed that the substance has suitable pharmacokinetic properties with rapid absorption in the body and relevant and dose-dependent exposure in the CNS. In addition, AC856 was shown to increase EEG activity in the brain, indicating that the substance reaches and activates regions of the brain that are central for cognitive-enhancing and antidepressive therapies."

P1 data • Alzheimer's Disease • CNS Disorders

Neuroprotective and Disease-Modifying Effects of the Triazinetrione ACD856, a Positive Allosteric Modulator of Trk-Receptors for the Treatment of Cognitive Dysfunction in Alzheimer's Disease. (PubMed, Int J Mol Sci) - "In conclusion, the results confirm ACD856 as a cognitive enhancer, but more importantly, they provide substantial in vitro and in vivo evidence of neuroprotective and long-term effects that contribute to neurotrophic support and increased neuroplasticity. Presumably, the described effects of ACD856 may improve cognition, increase resilience, and promote neurorestorative processes, thereby leading to a healthier brain in patients with AD."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • BDNF • NTRK2

Antidepressant effects of novel positive allosteric modulators of Trk-receptor mediated signaling - a potential therapeutic concept? (PubMed, Psychopharmacology (Berl)) - "Trk-PAMs could provide an interesting avenue for the development of novel therapeutics in this area."

Journal • CNS Disorders • Depression • Major Depressive Disorder • Mental Retardation • Mood Disorders • Psychiatry

New Article on Disease Modifying Data with NeuroRestore ACD856 against Alzheimer’s now Available Online (Yahoo Finance) - "AlzeCure Pharma...today announced that a new scientific article on preclinical results supporting a disease-modifying effect with NeuroRestore ACD856 has been made available online....'Neuroprotective and disease modifying effects of the triazinetrione ACD856, a positive allosteric modulator of Trk-receptors for the treatment of cognitive dysfunction in Alzheimer's disease'...The results show that ACD856 has positive effects on neurite outgrowth, has protective effects against amyloid-beta induced nerve damage and has positive effects on the synapses - the contact surfaces between nerve cells where the exchange of information takes place."

Preclinical • Alzheimer's Disease • CNS Disorders

AlzeCure is granted European patent for NeuroRestore ACD856 (Market Screener) - "AlzeCure Pharma...today announced that the European Patent Office (EPO) has granted a patent covering the company’s candidate drug ACD856, which is developed against Alzheimer's disease and other disorders with cognitive impairment....The company's patent application for ACD856 in Europe has been granted by the EPO and validated in 33 territories across Europe, including Germany, France, United Kingdom, Spain, Italy and Sweden. ACD856, the leading candidate drug in the NeuroRestore platform, is being developed against Alzheimer's disease. The patent number is 3 759 088 and the patent is expected to provide protection until 2039....The candidate drug recently completed phase I clinical trials where both good safety and tolerability were observed in humans, and ACD856 crossed the blood-brain barrier and activated regions of the brain central to both cognition and depression treatment. New preclinical results also show potential neuroprotective."

Patent • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Sleep Disorder

EFFECTS ON NEUROPROTECTION AND NEUROPLASTICITY BY THE CLINICAL COMPOUND ACD856, A NOVEL POSITIVE MODULATOR OF TRK-RECEPTORS FROM THE NEURORESTORE® PLATFORM. (ADPD 2023) - "The results indicate that ACD856 can act in a neuroprotective manner, modulate phospho -ERK1/2 levels and improve neuronal plasticity or in other ways increase network connectivity. The fact that A CD856 shows both symptomatic and potential disease -modifying effects is of high importance for the future treatment of patients with Alzheimer's disease and other neurodegenerative disorders."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Depression • Psychiatry • BDNF • NCAM1

AlzeCure gets Abstract Accepted on New Potential Disease-Modifying Effects of ACD856 Against Alzheimer's (Yahoo Finance) - “AlzeCure Pharma…announced that an abstract with new preclinical data supporting a disease-modifying effect of ACD856 has been accepted for presentation at the Alzheimer's Conference AD/PD 2023, to be held in Gothenburg, Sweden, March 28 - April 1….The presentation contains new preclinical results with ACD856, the leading drug candidate in the NeuroRestore platform, which in the studies shows, among other things, a protective effect on nerve cells and a positive effect of ACD856 on the growth of nerve fibers. Furthermore, the data show that ACD856 increases the amount of a specific protein that plays an important role in nerve cell communication, something that is strongly affected in the disease.”

Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders