What side effects are associated with this type of intervention?

Common treatments for Multiple System Atrophy (MSA) include medications to manage symptoms, such as levodopa for motor symptoms, and immunotherapy approaches like peptide-based vaccines similar to UB-312. Known side effects of levodopa include nausea, dizziness, and dyskinesia. Immunotherapy treatments, including peptide-based vaccines, may cause injection site reactions, flu-like symptoms, and potential autoimmune responses. It is important to discuss these treatments and their side effects with a healthcare provider to determine the best approach for managing MSA.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Multiple System Atrophy (MSA) that are similar to UB-312, a UBITh®-enhanced synthetic peptide-based vaccine for active immunotherapy. Current treatments for MSA primarily focus on managing symptoms rather than modifying the disease. These include medications to manage motor symptoms, autonomic dysfunction, and other supportive therapies. Research is ongoing to find disease-modifying therapies, including immunotherapy approaches like UB-312, which target synucleinopathies such as Parkinson's disease and MSA.

What other types of research exist?

Promising novel alternatives to UB-312 for Multiple System Atrophy patients include: 1) Antisense oligonucleotide therapy, such as Tofersen, which targets specific genetic mutations associated with neurodegenerative diseases. 2) Sodium phenylbutyrate/taurursodiol, which has shown efficacy in extending survival and reducing hospitalizations in ALS and may have potential applications in MSA. 3) Geniposide, which exhibits neuroprotective properties by inhibiting α-synuclein expression through the miR-21/LAMP2A axis. These therapies are in various stages of research and clinical trials and represent potential future treatment options for MSA.

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UB-312 Vaccine for Parkinson's & Multiple System Atrophy

Phase 1 & 2

Waitlist Available

Led By Horacio Kaufmann, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female aged 40 to 75 years old, inclusive, at screening.

A diagnosis of PD or MSA, confirmed by the PI, as per the current Movement Disorders Society's criteria (Postuma 2015, Wenning 2022).

Must not have

Received blood and/or blood derivatives treatment within 3 months before Screening.

Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, week 133

Summary

This trial tests a new vaccine called UB-312, which aims to help patients with MSA and PD by teaching their immune systems to attack harmful brain proteins.

Who is the study for?

This trial is for adults aged 40-75 with Parkinson's Disease or Multiple System Atrophy, confirmed by specific criteria. Participants must have a certain cognitive score, be within a specified weight range, and agree to use contraception if of childbearing potential. They should not have had recent investigational drug use, significant allergies, autoimmune disorders, or conditions that could interfere with the study.

What is being tested?

The trial tests UB-312 Injection against a placebo in patients with synucleinopathies like Parkinson's Disease and Multiple System Atrophy. UB-312 is an experimental vaccine aimed at providing active immunotherapy for these conditions. The study will assess safety, tolerability, and immune response.

What are the potential side effects?

As this is an early-phase trial primarily assessing safety and tolerability of UB-312 Injection (a synthetic peptide-based vaccine), detailed side effects are being determined but may include typical vaccine reactions such as soreness at injection site, fever, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 40 and 75 years old.

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I have been diagnosed with Parkinson's disease or Multiple System Atrophy.

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My BMI is between 18 and 32, and I weigh at least 50 kg.

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I am a male willing to use contraception during the study and for 90 days after, and will not donate sperm.

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My mental function score is above 21.

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I am fully vaccinated and boosted for COVID-19 as per local guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received a blood transfusion or blood products within the last 3 months.

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I have been in a trial for treatments targeting aSyn with antibodies or vaccines.

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I do not have metal implants or fragments that prevent me from having an MRI.

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I haven't lost or donated more than 500 mL of blood in the last 3 months.

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I have not had brain surgery, device implantation in the brain, or stem cell studies.

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My only cancers in the past 5 years were skin cancers that were removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, week 133

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, week 133

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, week 133 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in CSF Levels of anti-aSyn Antibodies from First Injection

Change in Serum Levels of anti-aSyn Antibodies from First Injection

Trial Design

4Treatment groups

Experimental Treatment

Group I: Treatment First - PDExperimental Treatment2 Interventions

Includes participants with PD only. Patients in the treatment-first arm will receive active treatment at weeks 1, 5, 13, 25, 37, 49, 73, and 97; and placebo doses at weeks 17, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).

Group II: Treatment First - MSAExperimental Treatment2 Interventions

Includes participants with MSA only. Patients in the treatment-first arm will receive active treatment at weeks 1, 5, 13, 25, 37, 49, 73, and 97; and placebo doses at weeks 17, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).

Group III: Delayed Start - PDExperimental Treatment2 Interventions

Includes participants with PD only. Patients in the delayed-start arm will receive placebo injections at weeks 1, 5, 73, and 97; and active treatment at weeks 13, 17, 25, 37, 49, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).

Group IV: Delayed Start - MSAExperimental Treatment2 Interventions

Includes participants with MSA only Patients in the delayed-start arm will receive placebo injections at weeks 1, 5, 73, and 97; and active treatment at weeks 13, 17, 25, 37, 49, 61, 85, and 109. Participants will be followed up for 24 weeks after their last dose. All participants will receive three priming doses of UB-312 300 µg, followed by 5 booster doses of UB-312 300 µg. To keep the blind, both treatment arms will receive active treatment and placebo injections for a total of 12 injections (8 active treatment injections + 4 placebo injections).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo Injection

2017

Completed Phase 4

~3790

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Multiple System Atrophy (MSA) often target the pathological accumulation of α-synuclein, a protein that aggregates and contributes to neurodegeneration. UB-312, a UBITh®-enhanced synthetic peptide-based vaccine, aims to provide active immunotherapy by inducing the body's immune system to produce antibodies against α-synuclein. This approach helps to reduce α-synuclein aggregation and its associated neurotoxic effects. For MSA patients, this is crucial as it addresses the underlying pathology of the disease, potentially slowing its progression and improving neurological function.

Azepine-Indole Alkaloids From Psychotria nemorosa Modulate 5-HT2A Receptors and Prevent in vivo Protein Toxicity in Transgenic Caenorhabditis elegans.Targeting α-synuclein by PD03 AFFITOPE® and Anle138b rescues neurodegenerative pathology in a model of multiple system atrophy: clinical relevance.Nasal inoculation with α-synuclein aggregates evokes rigidity, locomotor deficits and immunity to such misfolded species as well as dopamine.