Oligomerix - Model OLX07010 - Small Molecule Inhibitor of Tau Self-association
Our lead compound, known as OLX07010, is a small molecule inhibitor of tau self-association which has demonstrated in vivo efficacy in two transgenic mouse models of tauopathy, htau and JNPL3, representing tau aggregation in AD and inherited tauopathies, respectively.
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The htau model expresses all 6 human CNS tau isoforms, without the mutations that are found in inherited forms of tauopathy, in place of murine tau. JNPL3 mice express the human tau 4R0N isoform with the P301L mutation that can cause FTD and PSP. The blinded efficacy and confirmatory studies were independently performed by the late Peter Davies, Ph.D., Director, Litwin-Zucker Center for Alzheimer’s Disease & Memory Disorders, The Feinstein Institute for Medical Research, Northwell Health. Oligomerix is evaluating OLX07010 for both Rare tauopathies and AD and is planning first-in-human clinical trials in 2022.
OLX07010 in Rare Tauopathies
There exist numerous rare diseases that tau dysfunction is associated with known as tauopathies. While Alzheimer’s is the largest tauopathy, other tauopathies are rare diseases that present accelerated regulatory pathways and significant near-term commercial opportunities.
These rare diseases shown in Chart A below have a tau etiology similar to AD. Oligomerix’s 1st clinical program focuses on demonstrating safety and efficacy of our lead (OLX07010) in AD and in a rare disease tauopathy.
Rare tauopathy diseases generally have an earlier age of onset and more rapid disease course (versus Alzheimer’s disease) allowing for early signals of target engagement and the potential for a more rapid regulatory review.
As an oral, small molecule targeting tau-self association (the beginning stages of the tau aggregation cascade), OLX-07010 has the potential to be easily administered to improve patient compliance, accessible on a global scale and manufactured at lower costs compared to other approaches. Additionally, OLX-07010 could complement both tau and beta-amyloid antibody treatment.
OLX07010 Alzheimer’s
Our Alzheimer’s program (OLX07010) is a small molecule inhibitor of tau self-association which has demonstrated in vivo efficacy in two transgenic mouse models of tauopathy, htau and JNPL3, representing tau aggregation in AD and inherited tauopathies, respectively.
The mice were treated using a prevention paradigm and the recently published htau study demonstrated reduction of insoluble tau with statistical significance (Davidowitz EJ et al., 2020). A similar preventive study was performed using the JNPL3 mice in which mutated tau is more prone to misfold and aggregate and develop tau pathology more aggressively than what is observed in non-mutated tau. Even so, OLX07010 showed similar results to our studies in htau (manuscript in preparation)
Therapeutic studies dosed JNPL3 mice for five months (from 7 to 12 months of age) and showed similar results as our studies in preventive paradigm (manuscript in preparation)
The activity in these two models translated from in vitro and cellular assays to an in vivo model of tau aggregation validating our screening approach and showing that targeting tau-self association can inhibit the entire tau aggregation pathway.
Our lead program is poised to transition into Phase 1.
As an oral, small molecule targeting tau-self association (the beginning stages of the tau aggregation cascade), OLX-07010 has the potential to be easily administered to improve patient compliance, accessible on a global scale and manufactured at lower costs compared to other approaches. Additionally, OLX-07010 could complement both tau and beta-amyloid antibody treatment.
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