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Tau protein is necessary for neuronal signaling, but in AD and other tauopathies such as PSP and FTD, tau protein misfolds and aggregates, causing loss of normal function and toxic gain of function. The tau aggregates most closely correlated with neuronal loss and memory impairment are oligomers. Development of effective disease-modifying therapeutics and companion biomarkers have the potential to significantly impact disease prevention and progression.
Oligomerix® is developing disease modifying therapeutics (DMTs) for AD and PSP using a small molecule approach targeting tau oligomers, thereby reducing the accumulation of all tau aggregates. Oligomerix has shown that its lead compound, OLX-07010, prevents tau self-association and growth of aggregates early in the tau cascade.
OLX-07010 is in Ph 1a clinical development while several 2nd generation series are progressing toward development. Additionally, Oligomerix is developing a companion biomarker.
There remains a critical unmet need for oral, small molecule DMTs for AD and other tauopathies, despite the recent approvals of lecanamab and aducanumab antibodies. Globally incidence and prevalence of AD continues to increase due to aging populations. The introduction of an oral, small molecule DMT would be a blockbuster drug that drives U.S.-only sales estimates >$20 billion per year within 5 years. Development of effective, simple and well-validated blood-based biomarkers can facilitate early signals of clinical efficacy for AD.
Their lead oral, small molecule compound has clear elements of differentiation from antibodies including ease of use (oral vs. injectable), greater global access, likely lower cost of therapy and manufacturing. Our small molecule inhibitors target tau oligomers at the beginning of the aggregation process, before they self-associate into toxic tau oligomers.
Company Milestones
Scientific and Clinical
- 2021: Pre-Clinical Proof of Concept achieved in two animal models
- 2022: IND submitted to U.S. FDA
- 2023: Initiated Ph 1a clinical development early in 2023.
- 2024: TAPP mouse model confirms previous pharmacodynamic findings
- 2025: Complete Ph 1a development
Business
- 2024: Obtain investment and/or partnership to drive Oligomerix to initiate and complete Ph 1b
- 2024: Enhance overall awareness and image of Oligomerix via social media
Financial Overview
Oligomerix has raised$7.9 million, several small venture funds and individual investors, in addition to more than $25 million in non-dilutive funding through NIH/NIA grants. They are currently seeking to raise $1.5 million in Q1 2024. In the future, they hope to raise $30 million to fund Phase 1b in AD and PSP patients.
Intellectual Property
Oligomerix currently holds patents for intellectual property in various sectors, including novel chemical matter, methods for novel biomarker and target identification and development.
Composition of Matter and Methods of Use:
Expire December 17, 2037
- 11,472,776 Lead series composition of matter
- 11,306,075 Alternate series composition of matter
Other:
- 11,104,710 Methods and compositions comprising tau oligomers.
- 10,597,649 Tau protease compositions and methods of use
- 10,465,001 Antibody-based reagents that specifically recognize toxic oligomeric forms of tau
- 9,506,051 Tau protease compositions and methods of use
- 9,464,122 Methods and compositions comprising tau oligomers.
Pending or in Preparation:
Novel chemical matter, synthetic route, methods of use
Product Development and Regulatory Strategy
The overall objectives of the Development program for OLX-07010 is to demonstrate safety and efficacy of the lead compound in patients with AD and PSP. The IND was filed in June 2022 and the clinical program enrolled its first patient in February 2023. The initial clinical study is a SAD/MAD design to demonstrate safety and pharmacokinetics of the lead in healthy adult and elderly volunteers. Other studies planned include demonstrating the pharmacokinetics of the lead compound in CSF and the impact of food on the PK. In AD, a PhIb study will follow in patients to further establish the safety of the lead compound and to demonstrate efficacy of the compound through its ability to impact established and validated biomarkers of disease activity. In PSP, a rare neurodegenerative disease, a Ph1b study is designed to demonstrate the safety and PK in PSP patients. The PhIb study will be followed by a robust Ph2a study in PSP patients designed to demonstrate the safety and efficacy of the lead compound in these patients. The endpoints in the Ph2a study will be accepted and validated clinical endpoints such as the CDRS that may serve as substrate for an accelerated approval of the compound.
Commercialization Strategy
Oligomerix® developed a multi-faceted commercialization strategy that includes all key marketing elements such as extensive market research, development of a Target Product Profile (TPP), a full development plan, a public relations and medical communications program, and KOL and Patient Advocacy organization engagement. These elements are core to their goal of gaining a strategic partnership by the end of 2024 and are designed to help the partner accelerate our highly differentiated DMT and biomarker programs into full development and commercialization.
Company Details
Bronx, NY
Industry: Therapeutics
Management Team:
- CEO & Head of Discovery: James Moe, Ph.D.
- President & Head of Development: William Erhardt M.D.
- Chief Scientific Officer: Eliot Davidowitz, Ph.D.
- Chief Operating Officer/CFO: Robert Foerster
- Chief Commercial Officer: Jack Pasini
Point of Contact:
James Moe, Ph.D., MBA
jmoe@oligomerix.com
(646) 373-6897
SBIR