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- || Clinical, Pipeline update, Review, Journal: Advancements in Bullous Pemphigoid Treatment: A Comprehensive Pipeline Update. (Pubmed Central) - Jan 2, 2024
Targeting eosinophil-related molecules using bertilimumab and AKST4290 has yielded positive results in clinical trials. Omalizumab, an immunoglobulin (Ig)
- lazucirnon (AKST4290) / Grifols
Trial termination: A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI) (clinicaltrials.gov) - Nov 1, 2023
P2, N=3, Terminated, Sponsor: Alkahest, Inc.
Omalizumab, an immunoglobulin (Ig) Suspended --> Terminated; Study terminated due to safety findings in other AKST4290 studies
- | lazucirnon (AKST4290) / Grifols
Enrollment change, Trial termination: A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid (clinicaltrials.gov) - Sep 14, 2023
P2, N=6, Terminated, Sponsor: Alkahest, Inc.
Suspended --> Terminated; Study terminated due to safety findings in other AKST4290 studies N=30 --> 6 | Completed --> Terminated; The study was prematurely terminated by the Sponsor due to operational challenges stemming from the coronavirus disease 2019 (COVID-19) pandemic, treatment limitations, rarity of the disease, and drug supply considerations.
- | lazucirnon (AKST4290) / Grifols
Journal: Safety and therapeutic effects of orally administered AKST4290 in newly diagnosed neovascular age-related macular degeneration. (Pubmed Central) - May 26, 2022
All adverse events (AEs) were mild or moderate in severity and no safety issues were identified. Treatment of nAMD with AKST4290 warrants further investigation in randomized, placebo-controlled trials.
- | lazucirnon (AKST4290) / Grifols
Enrollment change, Trial completion date, Trial suspension, Trial primary completion date: A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI) (clinicaltrials.gov) - Feb 9, 2022
P2, N=3, Suspended, Sponsor: Alkahest, Inc.
Treatment of nAMD with AKST4290 warrants further investigation in randomized, placebo-controlled trials. N=80 --> 3 | Trial completion date: Oct 2022 --> Jul 2022 | Recruiting --> Suspended | Trial primary completion date: Sep 2022 --> Feb 2022
- lazucirnon (AKST4290) / Grifols
Pharmacokinetics and distribution of AKST4290, a CCR3 antagonist with anti-inflammatory properties in the eye and brain (Virtual Only) - Dec 20, 2021 - Abstract #Neuroscience2021Neuroscience_3445;
LC-MS/MS analysis also showed very low levels in the brain, together demonstrating that it is non-brain penetrant drug. These data suggest that AKST4290 treatment for nAMD can act both systemically as well as centrally in the RPE/choroid, where action may occur through inflammatory pathways.
- lazucirnon (AKST4290) / Grifols
CCR3 inhibition reduces recruitment of peripheral immune cells to the eye and brain in inflammatory disease models (Virtual Only) - Dec 20, 2021 - Abstract #Neuroscience2021Neuroscience_2241;
AKST4290, a CCR3 inhibitor, is a promising oral drug for AMD treatment...Preclinical studies using the sodium iodate (NaIO 3 ) induced oxidative stress model were subsequently conducted to examine whether the efficacy observed in nAMD patients was in part due to blocking CCR3-mediated retinal homing of damage-promoting immune cells from the periphery. This in turn could dampen local inflammation and may subsequently modify disease progression.
- lazucirnon (AKST4290) / Grifols
RESULTS OF A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF AKST4290 IN PARKINSON’S DISEASE (ONSITE: 112) - Dec 17, 2021 - Abstract #ADPD2022ADPD_282;
Conclusions Improvements with AKST4290 treatment were evident in select important assessments of relevance to PD patients. The results of this study support continued investigation of AKST4290 in neuroinflammation in PD.
- ||| lazucirnon (AKST4290) / Grifols
Trial completion: PHTHALO-205: A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD (clinicaltrials.gov) - Oct 11, 2021
P2, N=107, Completed, Sponsor: Alkahest, Inc.
The results of this study support continued investigation of AKST4290 in neuroinflammation in PD. Recruiting --> Completed
- |||| lazucirnon (AKST4290) / Grifols
New P2 trial: A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI) (clinicaltrials.gov) - Sep 7, 2021
P2, N=80, Recruiting, Sponsor: Alkahest, Inc.
- || lazucirnon (AKST4290) / Grifols
Trial completion date, Trial primary completion date: PHTHALO-205: A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD (clinicaltrials.gov) - Jul 22, 2021
P2, N=100, Recruiting, Sponsor: Alkahest, Inc.
Recruiting --> Completed Trial completion date: Apr 2021 --> Sep 2021 | Trial primary completion date: Apr 2021 --> Sep 2021
- || lazucirnon (AKST4290) / Grifols
Trial completion: A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid (clinicaltrials.gov) - Jul 8, 2021
P2, N=30, Completed, Sponsor: Alkahest, Inc.
Trial completion date: Apr 2021 --> Sep 2021 | Trial primary completion date: Apr 2021 --> Sep 2021 Recruiting --> Completed
- lazucirnon (AKST4290) / Grifols
[VIRTUAL] AKST4290, a CCR3 Inhibitor, Reduces Age-Related Inflammation and Immune Cell Infiltration () - May 19, 2021 - Abstract #IMMUNOLOGY2021IMMUNOLOGY_1368;
These findings suggest that AKST4290 is a potent immunomodulator that normalizes immune cell populations related to inflammation to healthy levels, both in the context of disease and aging. These immune modulatory and anti-inflammatory effects have functional consequences in aging models, indicating its therapeutic potential in multiple age-related disorders.
- lazucirnon (AKST4290) / Grifols
[VIRTUAL] Determining the pharmacokinetics and ocular distribution of AKST4290, a clinical stage oral therapeutic for age-related macular degeneration () - May 13, 2021 - Abstract #ARVO2021ARVO_345;
Moreover, these data show a strong effect of retinal pigmentation on the levels of drug accumulation in the eye. These data support the RPE/choroid as a potential site of AKST4290 action in nAMD and contextualize treatment efficacy observed in clinical trials.
- lazucirnon (AKST4290) / Grifols
[VIRTUAL] CCR3 inhibition reduces recruitment of peripheral immune cells to the eye in the sodium iodate model of age- related macular degeneration () - May 13, 2021 - Abstract #ARVO2021ARVO_344;
This reduction in recruitment of immune cells was associated with a decrease in chemokines in the degenerating RPE. These findings help illustrate the mechanism of action for AKST4290, supporting its observed efficacy as a drug candidate in clinical trials of nAMD patients.
- ||| lazucirnon (AKST4290) / Grifols
Trial completion: TEAL: Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment (clinicaltrials.gov) - May 11, 2021
P2, N=110, Completed, Sponsor: Alkahest, Inc.
These findings help illustrate the mechanism of action for AKST4290, supporting its observed efficacy as a drug candidate in clinical trials of nAMD patients. Recruiting --> Completed
- ||| lazucirnon (AKST4290) / Grifols
Live at #ARVO2021 RPE/choroid as potential site of action in nAMD for CCR3 inhibitor AKST4290 from Alkahest (Twitter) - May 1, 2021
- | Journal: Emerging Therapies in Neovascular Age-Related Macular Degeneration in 2020. (Pubmed Central) - Apr 10, 2021
Nine other upcoming agents have at least produced results in the 2A phase including intravitreal injections (KSI-301, OPT-302, RGX-314, ICON-1, and DE-122), depot (GB-102), drug reservoir (PDS), topical drops (PAN-90806), and oral formulations (AKST4290). We summarize all the newer molecules.
- || lazucirnon (AKST4290) / Grifols
Trial completion date, Trial primary completion date: TEAL: Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment (clinicaltrials.gov) - Jan 11, 2021
P2, N=120, Recruiting, Sponsor: Alkahest, Inc.
We summarize all the newer molecules. Trial completion date: Nov 2020 --> Mar 2021 | Trial primary completion date: Nov 2020 --> Mar 2021
- AKST4290 / Alkahest
[VIRTUAL] A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson’s Disease on Stable Dopaminergic Treatment (TEAL Study) () - Sep 20, 2020 - Abstract #MDSCongress2020MDS Congress_977;
AKST4290 has the potential to provide an alternative treatment option for patients with PD. TEAL will be the first Phase II randomized study to establish efficacy and safety of AKST4290 in PD.
- || lazucirnon (AKST4290) / Grifols
New P2 trial: A Study to Assess the Therapeutic Effect and Safety of Adjunctive AKST4290 in Subjects With Bullous Pemphigoid (clinicaltrials.gov) - Aug 6, 2020
P2, N=30, Recruiting, Sponsor: Alkahest, Inc.
- |||| lazucirnon (AKST4290) / Grifols
New P2 trial: TEAL: Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic Treatment (clinicaltrials.gov) - Apr 29, 2020
P2, N=120, Recruiting, Sponsor: Alkahest, Inc.
- |||| lazucirnon (AKST4290) / Grifols
New P2 trial: PHTHALO-205: A Study to Assess the Efficacy and Safety of AKST4290 With Aflibercept in Patients With Newly Diagnosed nAMD (clinicaltrials.gov) - Apr 1, 2020
P2, N=100, Recruiting, Sponsor: Alkahest, Inc.
- AKST4290 / Alkahest
CCR3 inhibition reduces reactive gliosis in the sodium iodate model of age-related macular degeneration (Exhibit Hall: Posterboard# B0249) - Mar 9, 2020 - Abstract #ARVO2020ARVO_2808;
The study data also found that the effects of AKST4290 in treating AMD might be due to the ability of AKST4290 to suppress the activity of specific types of immune cells that are suggested to play a negative role in AMD. Together, these findings help illustrate how AKST4290 functions in injured eyes, supporting its observed effectiveness as a drug candidate in clinical trials in AMD patients.
- AKST4290 / Alkahest
Rationale and Design of a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson’s Disease on Stable Dopaminergic Treatment () - Feb 3, 2020 - Abstract #AAN2020AAN_5146;
Robust preclinical evidence in rodent models of PD provides the foundation for development of this novel therapeutic approach in humans. In this Phase 2 study, the efficacy and safety of 12 weeks of AKST4290 in subjects with PD will be assessed.
- || lazucirnon (AKST4290) / Grifols
Trial completion: Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Dec 6, 2018
P2, N=30, Completed, Sponsor: Alkahest, Inc.
In this Phase 2 study, the efficacy and safety of 12 weeks of AKST4290 in subjects with PD will be assessed. Recruiting --> Completed
- || lazucirnon (AKST4290) / Grifols
Trial completion: Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Dec 6, 2018
P2, N=26, Completed, Sponsor: Alkahest, Inc.
Recruiting --> Completed Recruiting --> Completed
- || lazucirnon (AKST4290) / Grifols
New P2 trial: Evaluate the Effects and Safety of ALK4290 in Patients With Newly Diagnosed Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Jul 15, 2018
P2, N=30, Recruiting, Sponsor: Alkahest, Inc.
- || lazucirnon (AKST4290) / Grifols
New P2 trial: Evaluate the Therapeutic Effects and Safety of ALK4290 in Patients With Refractory Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Jul 15, 2018
P2, N=30, Recruiting, Sponsor: Alkahest, Inc.