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IGC Pharma heads towards a Phase I study for Alzheimer’s disease
2024-02-02
临床1期临床2期临床结果临床3期上市批准
TGR-63, being developed to target amyloid-beta plaques, has shown preclinical potential in reducing Alzheimer’s-related anxiety. Credits: AtlasStudio/Shutterstock.com
TGR-63ositive preclinical data foramyloid-beta plaquesease drug candidate TGR-63, IGC Pharma has announced that it plans to advance this small molecule into early clinical development in the course of 2024.
TGR-63 is an amyloid beta peptide-targeAlzheimer’s diseaseto decrease plaqTGR-63reIGC Pharmapreventing the misfolding and aggregation of amyloid-beta peptides. In the preclinical mouse models designed to assess behavioural responses in transgenic mice, subjects treated with TGR-63 demonstrated statistically significant reductions (43%) in overall movement as determined by an Open-Field behavioural test.
TGR-63 the 1 February press release, the data reinforces “its [TGR-63] potential as a promising treatment” for reducing levels of anxietyamyloid-beta peptidesnal wellbeing.TGR-63
The Timonium, Maryland-based pharmaceutical company is also actTGR-63evaluating its cannabinoid-based lead candidate IGC-AD1 as a anxietynt for Alzheimer’s dementia-associated agitation in a Phase IIb study (NCT05543681). In December 2023, the company announced a partnership with Los Andes University’s Center for Research and Training in Artificial Intelligence (CINFONIA) to incorporate generative AI analyses into the Phase II trial.
IGC Timoniums in the process of training algorithms with the goal of identifying clues for reducing misdiagnoses and IGC-AD1egatives, which is iAlzheimer’s dementia-associated agitationves tend to be high in the Alzheimer’s indication, CEO Ram Mukunda told Pharmaceutical Technology. By addressing these issues, the company aims to improve trial success rates and ultimately accelerate the development and delivery of economic, effective treatments for Alzheimer’s patients, he adds.
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Despite making headway with its lead pipeline candidate, IGC Pharma has faced difficulties in trial enrolment and finances for IGC-AD1 due to its active ingredient being the psychoactive substance tetrahydrocannabinol (THC).
Tyra Biosciences rTYRA-300 and therefore the study or use of it requires a special permit as it is not covered by a DEA license that could be used for a drug like morphine, Mukunda explained.
While Otsuka Pharmaceuticals’ Rexulti (brexpiprazole), an atypical antipsychotic, is the only FDA-approved medication for Alzheimer’s-associated agitation, other small molecules are in clinical development for Alzheimer’s agitation.
Otsuka is evaluating AVP-786, a dextromethorphan/quinidinIGC Pharmaion treatment for Alzheimer’s agitation, in multiple global IGC-AD1II studies. Similar to IGC Pharma, Sunnybrook Health Sciences Ctetrahydrocannabinol (THC) Phase III trial (NCT04516057) of cannabinoid based Nabilone for the treatment of agitation.
GlobalOtsuka Pharmaceuticalspany of Pharmaceutical Technolatypical antipsychoticAlzheimer’s-associated agitationAlzheimer’s agitation
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