With positive preclinical data for its Alzheimer’s disease 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-targeting drug designed to decrease plaque aggregation by preventing 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.
As per the 1 February press release, the data reinforces “its [TGR-63] potential as a promising treatment” for reducing levels of anxiety and improving emotional wellbeing.
The Timonium, Maryland-based pharmaceutical company is also actively evaluating its cannabinoid-based lead candidate IGC-AD1 as a treatment 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 Pharma is in the process of training algorithms with the goal of identifying clues for reducing misdiagnoses and false negatives, which is important as misdiagnoses and false negatives 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.
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).
THC is federally regulated 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/quinidine combination treatment for Alzheimer’s agitation, in multiple global Phase III studies. Similar to IGC Pharma, Sunnybrook Health Sciences Centre is also conducting a Phase III trial (NCT04516057) of cannabinoid based Nabilone for the treatment of agitation.
GlobalData forecasts Rexulti to bring $3.9 billion in sales in 2028.
GlobalData is the parent company of Pharmaceutical Technology.
