Clinical Evaluation of MucoPEG™ for Xerostomia

(CEMPEG Trial)

Recruiting at 1 trial location

Overseen By Jamie L Seifert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SunBio, Inc.

Must not be taking: Parasympathetic medications

Disqualifiers: Pregnancy, Breastfeeding, Radiotherapy, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

42 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two different mouth rinses, MucoPEG™ and Biotene®, to see which one works better for people with dry mouth. The study involves 42 patients who will use each rinse for a short period. The goal is to find out which rinse helps keep the mouth moist and comfortable. Biotene® is a widely used product for managing dry mouth symptoms.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications for dry mouth with unstable doses.

What safety data exists for the treatment known as Biotene or MucoPEG?

The safety of biotechnological products, like Biotene or MucoPEG, is generally addressed by regulatory frameworks that evaluate their benefit/risk, quality, and safety through preclinical testing. However, specific safety data for these particular treatments is not detailed in the available research articles. ^{1 2 3 4 5}

How does the drug Biotene, MucoPEG differ from other treatments for this condition?

Biotene, MucoPEG is unique because it likely involves a mucoadhesive system, which means it can stick to mucous membranes, potentially providing longer-lasting effects and reducing the frequency of application compared to other treatments. This approach is similar to other mucoadhesive systems used in ocular treatments, which enhance drug retention and effectiveness. ^{6 7 8 9 10}

Research Team

To be determined To be determined, DDS

Principal Investigator

Study Site

Eligibility Criteria

Inclusion Criteria

Participant agrees not to eat, drink, chew tobacco, chew gum, smoke, brush or floss their teeth for 2 hours prior to study visits

Participant agrees not to use any oral care products or any type of breath mint or lozenges for 2 hours prior to study visits

Participant with a Challacombe Scale score of 1 or higher

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either MucoPEG™ or Biotene® oral rinse twice a day for two weeks

2 weeks

2 visits (in-person)

Wash-out

Participants undergo a wash-out period before switching treatments

1 week

Treatment Period 2

Participants switch to the other oral rinse and use it twice a day for two weeks

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Biotene
• MucoPEG

Participant Groups

Group I: MucoPEG Experimental Treatment 1 Intervention

Arm being compared to against Biotene

Group II: Biotene Active Control 1 Intervention

Arm being compared against MucoPEG

Who Is Running the Clinical Trial?

SunBio, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Rudacure

Industry Sponsor

Trials

1

Recruited

40+

NAMSA

Collaborator

Trials

55

Recruited

21,500+

Findings from Research

The 4th Annual European Biosafe meeting highlighted significant challenges in non-clinical safety testing of biopharmaceuticals, particularly regarding immune activation and the complexities of innovative therapies like CAR-T cells.

Discussions emphasized the importance of using pharmacokinetic and pharmacodynamic data to optimize toxicology study designs, which can improve human risk assessments for these advanced therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies. Brennan, FR., Baumann, A., Blaich, G., et al.[2015]

The EU council directives provide a comprehensive regulatory framework to ensure the safety of biotechnological medicinal products, focusing on benefit/risk evaluation and quality assessment.

The framework emphasizes the importance of preclinical safety and efficacy testing before new drug applications are approved, ensuring that new treatments are both safe and effective for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biotechnological products. Bass, R., Purves, J., Amati, MP.[2019]

The BIOBADASER III registry, initiated in December 2015, includes data from 2,664 patients with rheumatic diseases treated with biological or synthetic drugs, focusing on tracking adverse events and treatment effectiveness.

In the first year, the most common adverse events reported were infections and infestations, highlighting the need for ongoing monitoring of safety in patients undergoing long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectives and methodology of BIOBADASER phase iii. Sanchez-Piedra, C., Hernández Miguel, MV., Manero, J., et al.[2021]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Nonclinical safety testing of biopharmaceuticals--Addressing current challenges of these novel and emerging therapies. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

International Conference on Harmonisation; addendum to International Conference on Harmonisation Guidance on S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals; availability. Notice. [2013]

3. Denmark pubmed.ncbi.nlm.nih.gov

Safety of biotechnological products. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

Objectives and methodology of BIOBADASER phase iii. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Real World Data on the Utilization Pattern and Safety Profile of Infliximab Originator Versus Biosimilars in Italy: A Multiregional Study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Sodium alginate based mucoadhesive system for gatifloxacin and its in vitro antibacterial activity. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Improvement of bone microarchitecture in methylprednisolone induced rat model of osteoporosis by using thiolated chitosan-based risedronate mucoadhesive film. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

In silico modeling of functionalized poly(methylvinyl ether/maleic acid) for controlled drug release in the ocular milieu. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Ocular antibacterial chitosan-maleic acid hydrogels: In vitro and in vivo studies for a promising approach with enhanced mucoadhesion. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Mucoadhesive liposomes as ocular delivery system: physical, microbiological, and in vivo assessment. [2022]