- |||||||||| davunetide intranasal (AL-108) / Endo
Review, Journal: Microtubule stabilising peptides: new paradigm towards management of neuronal disorders. (Pubmed Central) - Nov 17, 2023
Therefore, a systematic updated review on MT stabilising peptides may shed light on many hidden aspects and enable researchers to develop new therapies for diseases related to the CNS. In this review we have summarised the recent examples of peptides as MSAs.
- |||||||||| davunetide intranasal (AL-108) / Endo
Journal: Unexpected gender differences in progressive supranuclear palsy reveal efficacy for davunetide in women. (Pubmed Central) - Oct 22, 2023
Female-specific davunetide-mediated protection of ventricular volume corresponded to clinical efficacy. Together with the significantly slower disease progression seen in men, the results reveal sex-based drug efficacy differences, demonstrating the neuroprotective and disease-modifying impact of davunetide treatment for female PSP patients.
- |||||||||| davunetide intranasal (AL-108) / Endo
Journal: Tau, ADNP, and sex. (Pubmed Central) - Aug 12, 2023
I then moved to the original discovery of ADNP and its active neuroprotective site, NAP, drug candidate, davunetide. Tau-ADNP-NAP interactions were then explained with emphasis on sex and future translational medicine.
- |||||||||| davunetide intranasal (AL-108) / Endo, oxytocin intranasal (TNX-1900) / Tonix
Review, Journal: Intranasal Peptide Therapeutics: A Promising Avenue for Overcoming the Challenges of Traditional CNS Drug Development. (Pubmed Central) - Nov 27, 2022
However, targeted nose-to-brain, or intranasal (IN), approaches have begun to emerge that allow CNS-specific delivery of therapeutics via the trigeminal and olfactory nerve pathways, laying the foundation for improved alternatives to systemic drug delivery. Here we review a dozen promising IN peptide therapeutics in preclinical and clinical development for neurodegenerative (Alzheimer's, Parkinson's), neuropsychiatric (depression, PTSD, schizophrenia), and neurodevelopmental disorders (autism), with insulin, NAP (davunetide), IGF-1, PACAP, NPY, oxytocin, and GLP-1 agonists prominent among them.
- |||||||||| davunetide intranasal (AL-108) / Endo
Journal: Rational Discovery of Microtubule-Stabilizing Peptides. (Pubmed Central) - Sep 11, 2022
Tryptophan quenching assays verified that P43 and P52 bind to nonpolymeric tubulin, whereas viability experiments on HEK cells confirmed their safety to pursue future pharmacological studies. The results herein presented are valuable to making progress in the rational design of MT-stabilizing peptides.
- |||||||||| davunetide intranasal (AL-108) / Endo
Journal: A Modified Progressive Supranuclear Palsy Rating Scale for Virtual Assessments. (Pubmed Central) - Jun 22, 2022
Modified versions of the PSPRS which can be administered remotely show excellent agreement with the original scale and predict survival in PSP. The mPSPRS-21 should facilitate clinical care and research in PSP via teleneurology.
- |||||||||| davunetide intranasal (AL-108) / Endo, napabucasin (BBI608) / Sumitomo Dainippon, Boston Pharma
Journal: A Novel Small Molecule, LCG-N25, Inhibits Oral Streptococcal Biofilm. (Pubmed Central) - Apr 21, 2021
We found that LCG-N25 exhibited a good antibacterial activity, low-cytotoxicity, and did not induce drug resistance of cariogenic S. mutans. These findings suggest that LCG-N25 may represent a promising antimicrobial agent that can be used as an adjuvant to the management of dental caries.
- |||||||||| davunetide intranasal (AL-108) / Endo
Journal: Potential for Treatment of Neurodegenerative Diseases with Natural Products or Synthetic Compounds that Stabilize Microtubules. (Pubmed Central) - Feb 24, 2021
Although promising results have come from animal model studies using brain-penetrant natural product microtubule stabilizing agents such as paclitaxel analogs because of poor blood-brain barrier penetration of the parental compound, epothilones B and D, and other synthetic compounds such as davunetide or the triazolopyrimidines, early clinical trials in humans have been disappointing. This review aims to summarize the research that has been carried out in this area and discuss the potential for the future development of an effective microtubule stabilizing drug to treat neurodegenerative disease.
- |||||||||| davunetide intranasal (AL-108) / Endo
Review, Journal: The ADNP Syndrome and CP201 (NAP) Potential and Hope. (Pubmed Central) - Dec 19, 2020
Further studies showed that the ADNP microtubule-interacting fragment NAP (called here CP201) resolves, in part, Adnp deficiencies and protects against ADNP pathogenic sequence variant abnormalities. With a clean toxicology and positive human adult experience, CP201 is planned for future clinical trials in the ADNP syndrome.
- |||||||||| davunetide intranasal (AL-108) / Endo, amantadine / Generic mfg.
[VIRTUAL] Correlations between amantadine usage, gait, and cognition in PSP: a post hoc analysis of the davunetide trial () - Sep 20, 2020 - Abstract #MDSCongress2020MDS Congress_1147;
Also, the PSPRS does not include a measure of freezing of gait; this is relevant because some clinicians note freezing of gait responds to amantadine in a subset of PSP patients. Cognitive deficits strongly correlated over time with worsening of gait and balance in this population, but also with total PSPRS scores, likely reflective of overall disease progression.
- |||||||||| davunetide intranasal (AL-108) / Endo
Review, Journal: Single-cell analysis of cytoskeleton dynamics: From isoelectric focusing to live cell imaging and RNA-seq. (Pubmed Central) - Sep 13, 2020
With the advantage of molecular cloning and fluorescent protein tagging, essential components for microtubule dynamics/stability and function were identified, including activity-dependent neuroprotective protein, ADNP and its peptide snippet, NAP (drug candidate, davunetide/CP201)...Recent transcriptomic analysis of the young mouse brain at the single cell level enabled characterization of cell-type specific cytoskeleton related gene signatures (e.g., tubulin transcripts, microtubule-associated protein Tau, Mapt and microtubule end binding protein, EB3, Mapre3) at unprecedented detail. Here, we review these findings with a methodological perspective to highlight how cutting-edge techniques have allowed us to disentangle cytoskeleton dynamics in health and disease.
- |||||||||| Disalcid (salsalate) / Bausch Health, davunetide intranasal (AL-108) / Endo
Clinical, P1 data, Journal: Open-Label Phase 1 Futility Studies of Salsalate and Young Plasma in Progressive Supranuclear Palsy. (Pubmed Central) - May 8, 2020
Neither salsalate nor young plasma had a detectable effect on disease progression in PSP-RS. Focused open-label clinical trials incorporating historical clinical, neuropsychological, fluid, and imaging biomarkers provide useful preliminary data about the promise of novel PSP-directed therapies.
- |||||||||| davunetide intranasal (AL-108) / Endo
Journal: Crafting of Neuroprotective Octapeptide from Taxol-binding Pocket of β-Tubulin. (Pubmed Central) - May 8, 2019
Further, results revealed that this peptide is non-toxic against both PC12 derived neurons as well as primary cortical neurons. We believe that our strategy and discovery of peptide-based microtubule stabilizer will open the door for the development of potential anti-AD therapeutics in near future.
- |||||||||| davunetide intranasal (AL-108) / Endo
Phase classification: Davunetide (AL-108) in Predicted Tauopathies - Pilot Study (clinicaltrials.gov) - Apr 20, 2019
P1, N=12, Completed,
We believe that our strategy and discovery of peptide-based microtubule stabilizer will open the door for the development of potential anti-AD therapeutics in near future. Phase classification: P2 --> P1
- |||||||||| davunetide intranasal (AL-108) / Endo
Trial primary completion date: Davunetide (AL-108) in Predicted Tauopathies - Pilot Study (clinicaltrials.gov) - Dec 7, 2016
P2, N=12, Active, not recruiting,
Active, not recruiting --> Completed Trial primary completion date: Jul 2016 --> Jul 2017
- |||||||||| davunetide intranasal (AL-108) / Endo
Trial primary completion date: Davunetide (AL-108) in Predicted Tauopathies - Pilot Study (clinicaltrials.gov) - Jan 28, 2016
P2, N=12, Active, not recruiting,
Trial primary completion date: Jul 2016 --> Jul 2017 Trial primary completion date: Dec 2015 --> Jul 2016
- |||||||||| davunetide intranasal (AL-108) / Endo
Trial primary completion date: Davunetide (AL-108) in Predicted Tauopathies - Pilot Study (clinicaltrials.gov) - Jun 11, 2015
P2, N=12, Active, not recruiting,
Trial primary completion date: Dec 2015 --> Jul 2016 Trial primary completion date: Dec 2014 --> Dec 2015
- |||||||||| davunetide intranasal (AL-108) / Endo
Trial primary completion date: Davunetide (AL-108) in Predicted Tauopathies - Pilot Study (clinicaltrials.gov) - Jul 10, 2014
P2, N=12, Active, not recruiting,
Trial primary completion date: Dec 2014 --> Dec 2015 Trial primary completion date: Dec 2013 --> Dec 2014
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