OLX-07010 for Alzheimer's Disease Prevention

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Oligomerix, Inc

Must not be taking: Prescription drugs, Herbal supplements

Disqualifiers: Cardiovascular, Respiratory, Hepatic, others

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OLX-07010, a potential drug, to determine its effectiveness in preventing Alzheimer's disease. Researchers aim to assess its safety, how the body processes it, and its effects when taken with or without food. Participants will receive either the treatment or a placebo in various doses. The trial seeks healthy adults with no major medical issues who are not using other medications. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking any prescription drugs, herbal supplements, and over-the-counter medications before joining the trial. Prescription drugs and herbal supplements must be stopped 30 days before, and over-the-counter medications and dietary supplements must be stopped 2 weeks before the trial starts.

Is there any evidence suggesting that OLX-07010 is likely to be safe for humans?

Research has shown that OLX-07010 has been promising in early studies. In mice, it stopped the buildup of tau proteins, which are linked to Alzheimer's disease, indicating potential use in humans. However, since this is the first human trial of OLX-07010, researchers are still assessing its safety. This early trial aims to evaluate how well people tolerate OLX-07010 and identify any side effects. Most information currently comes from animal studies, so further research is necessary to fully understand its safety for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard Alzheimer's treatments that primarily focus on managing symptoms, OLX-07010 is unique because it aims to prevent the disease from developing in the first place. Most treatments for Alzheimer's, like donepezil or memantine, work by addressing neurotransmitter imbalances to improve cognitive function. However, OLX-07010 is being explored for its potential to target the underlying causes of Alzheimer's before symptoms even appear. Researchers are excited about OLX-07010 because it may offer a proactive approach to Alzheimer's, potentially altering the disease's progression rather than just managing its symptoms.

What evidence suggests that OLX-07010 might be an effective treatment for Alzheimer's?

Research has shown that OLX-07010, the investigational treatment in this trial, may help treat diseases like Alzheimer's, which involve tau protein tangles. Studies have found that this drug can reduce these tau tangles, a key component of Alzheimer's disease. In animal tests, OLX-07010 prevented the buildup of tau clumps, potentially slowing the disease's progress. These findings suggest that OLX-07010 could effectively prevent Alzheimer's by targeting tau proteins. Participants in this trial will receive either OLX-07010 or a placebo to evaluate its effectiveness in preventing Alzheimer's. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Healthy adults aged 18-50 and healthy elderly individuals aged 51-75, all of non-childbearing potential, can participate. They must have a stable weight within certain BMI ranges and no significant medical history or current conditions that could affect the study drug's processing in the body.

Inclusion Criteria

Participant voluntarily agrees to participate and signs an approved informed consent prior to performing any of the Screening Visit procedures.

I am between 51-75 years old and cannot have children, participating in Part 3 of the study.

I am a man weighing at least 55 kg or a woman weighing at least 50 kg with a BMI of 18-30 for most parts of the study, and 18-32 for part 3.

Exclusion Criteria

I am showing signs of or have tested positive for COVID-19.

I have difficulty with blood draws or IV access due to poor veins.

Participant has previously been enrolled in this clinical study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive single ascending doses of OLX-07010 to evaluate safety, tolerability, and pharmacokinetics

1 week

Multiple visits over 4 days for blood collection and monitoring

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of OLX-07010 to evaluate safety, tolerability, and pharmacokinetics

2 weeks

Daily visits for dosing and monitoring, with additional follow-up visits

Food Effect Study (Optional)

Participants receive OLX-07010 with and without food to evaluate the effect of food on drug pharmacokinetics

1 week

2 periods of dosing with crossover design

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OLX-07010

Trial Overview The trial is testing OLX-07010, a new medication aimed at inhibiting tau protein association which is implicated in Alzheimer's disease. It will be given in varying doses to see how safe it is and how it behaves inside the body when taken alone or with food.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

Active OLX-07010 in single ascending and multiple ascending dose cohorts

Group II: Placebo Placebo Group 1 Intervention

OLX-07010 placebo in single ascending and multiple ascending dose cohorts

Who Is Running the Clinical Trial?

Oligomerix, Inc

Lead Sponsor

Trials

1

Recruited

90+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11886763/

Therapeutic Treatment With OLX‐07010 Inhibited Tau ... This small molecule has potential for treating neurodegenerative diseases characterized by tau aggregation such as AD and progressive supranuclear palsy.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40052227/

Therapeutic Treatment With OLX-07010 Inhibited Tau ... This small molecule has potential for treating neurodegenerative diseases characterized by tau aggregation such as AD and progressive supranuclear palsy.

3. drugtargetreview.com drugtargetreview.com/news/158090/new-drug-olx-07010-shows-promise-in-treating-tau-diseases/

Drug OLX-07010 shows promise in treating tau diseases OLX-07010, a new drug from Oligomerix, shows potential in reducing tau protein tangles, a key factor in Alzheimer's and other tau-related diseases.

4. biospace.com biospace.com/oligomerix-presents-data-on-lead-program-at-clinical-trials-on-alzheimer-s-disease-ctad-conference-and-society-for-neuroscience-meeting

Oligomerix Presents Data on Lead Program at Clinical ... Statistically significant results showed that treatment prevented further accumulation of tau aggregates and overall levels of tau in the mice ...

5. firstwordpharma.com firstwordpharma.com/story/5769187

Oligomerix Publishes Preclinical Data on Novel Small ... Oligomerix Publishes Preclinical Data on Novel Small Molecule Therapeutic in Development for Alzheimer's Disease and Rare. Results published ...

6. businesswire.com businesswire.com/news/home/20250312573127/en/Oligomerix-Published-Results-from-a-Preclinical-Therapeutic-Treatment-Study-on-an-Oral-Experimental-Drug-in-Development-for-Alzheimers-and-Rare-Neurodegenerative-Diseases

Oligomerix Published Results from a Preclinical ... “This study shows that treatment of mice with pre-existing tau aggregates with OLX-07010 can block the further accumulation of tau aggregates.

7. reporter.nih.gov reporter.nih.gov/project-details/11068370

A 13-Week Oral Gavage Toxicity Study of OLX-07010 in ... Results of the preclinical studies have shown that OLX-07010 demonstrated pharmacologic activity in preventive and therapeutic studies in two mouse models of ...