RXRG001 for Dry Mouth

(SPRINX-1 Trial)

Recruiting at 3 trial locations

Overseen By RiboX Therapeutics Ltd.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: RiboX Therapeutics Ltd.

Disqualifiers: Infection, Heart failure, Diabetes, Autoimmune, others

Compensation: Varies

Number of Visits: Unknown

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment called RXRG001 for individuals experiencing dry mouth and reduced saliva production due to past radiation treatment for head and neck cancer. In the first part, all participants receive the treatment to determine the appropriate dose. The second part compares RXRG001 with a placebo to evaluate its effectiveness. Suitable candidates are adults who have received radiation for head and neck cancer, have been cancer-free for at least two years, and continue to suffer from dry mouth symptoms that haven't improved for at least three months. As a Phase 1, Phase 2 trial, this research focuses on understanding how RXRG001 works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking treatment development.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that RXRG001 is likely to be safe for humans?

Research shows that RXRG001 is undergoing its first human trials, so limited information exists on human reactions. RXRG001 aims to increase saliva production, potentially relieving dry mouth symptoms from radiation treatment. In this early testing stage, the primary goal is to identify side effects and assess treatment tolerance.

As RXRG001 is in an early phase trial, researchers are actively collecting safety data. They closely monitor participants for adverse reactions to ensure safety. In later stages, more safety information would be available, but currently, researchers are still learning about its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about RXRG001 for dry mouth because it offers a novel approach by being administered directly into the salivary glands, which is different from the standard oral or topical treatments currently available. This method could potentially deliver the active ingredient more effectively to the target area. Additionally, RXRG001 is being tested in both single and multiple dose regimens, which may provide flexibility in treatment options and improve patient outcomes. This direct, targeted delivery system might lead to faster and more efficient relief of symptoms compared to existing therapies.

What evidence suggests that RXRG001 might be an effective treatment for dry mouth?

Research has shown that RXRG001 is designed to alleviate dry mouth caused by radiation therapy by increasing a protein called hAQP1, which boosts saliva production. In animal studies, RXRG001 demonstrated a good balance between risks and benefits, suggesting potential usefulness for people. This trial will test RXRG001 in two parts: Part 1 involves an open-label, single-arm study with various dose cohorts, while Part 2 includes a randomized double-blind study comparing RXRG001 to a placebo. This marks the first time a circular RNA treatment is being tested for this condition and the first time it is being tried in humans. Although more data from human trials is needed, early signs from lab studies are promising. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with dry mouth caused by radiation therapy, specifically those who produce less saliva. Participants must be healthy enough to undergo the treatment and not have conditions that could interfere with the study or pose additional health risks.

Inclusion Criteria

Both parotid glands on imaging examination

I have had dry mouth or low saliva for over 3 months after treatment.

I have been cancer-free and had no other cancer types for at least 2 years.

Exclusion Criteria

I do not have heart failure, kidney issues, or uncontrolled diabetes (A1c <= 8%).

I do not have any active infections.

Active smoker or use tobacco products or have a history of substance or alcohol abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Open-label, single-arm study with unilateral administrations of RXRG001 in 3 single ascending dose cohorts and 3 multiple ascending dose cohorts

36 weeks

Treatment Part 2

Randomized, double-blind, placebo-controlled study with bilateral administrations of RXRG001 in 3 multiple ascending dose cohorts

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RXRG001

Trial Overview The study tests RXRG001, a new circular RNA treatment administered into salivary glands. It has two parts: an initial phase where patients get varying doses in one gland, and a second double-blind phase where they receive it in both glands or a placebo without knowing which.

How Is the Trial Designed?

Group I: RXRG001 Part 2 Experimental Treatment 1 Intervention

Randomized double-blind with 3 subsequent multiple dose cohorts. RXRG001 is administered intraductally in the salivary gland (bilateral)

Group II: RXRG001 Part 1 Experimental Treatment 1 Intervention

Open-label, single arm with 6 subsequent dose cohorts (3 single dose and 3 multiple dose cohorts) of RXRG001 administered intraductally in the salivary gland (unilateral)

Group III: Placebo Part 2 Placebo Group 1 Intervention

Randomized double-blind with 3 subsequent multiple dose cohorts. Placebo is administered intraductally in the salivary gland (bilateral)

Who Is Running the Clinical Trial?

RiboX Therapeutics Ltd.

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06714253

NCT06714253 | Study of Circular RNA Treatment in ... This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in adult ...

2. ddw-online.com ddw-online.com/first-circular-rna-begins-trials-in-radiation-induced-xerostomia-34457-202504/

First circular RNA begins trials in radiation-induced ... RXRG001 is the first circular RNA therapy to receive FDA IND clearance. Xerostomia and hyposalivation are common side effects of radiation therapy in head and ...

3. cgtlive.com cgtlive.com/view/ribox-circular-rna-therapy-rxrg001-cleared-phase-trial-radiation-induced-xerostomia-hyposalivation

RiboX's Circular RNA Therapy Cleared for Phase 1/2a Trial It is intended to produce overexpression of hAQP1 in order to promote elevated saliva production to ameliorate the symptoms of dry mouth ...

4. prnewswire.com prnewswire.com/news-releases/ribox-therapeutics-announces-first-patient-dosed-in-phase-iiia-clinical-trial-of-rxrg001-the-first-circular-rna-therapy-for-the-treatment-of-radiation-induced-xerostomia-and-hyposalivation-302395477.html

RiboX Therapeutics Announces First Patient Dosed ... Radiation therapy often results in damage to salivary glands and a significant decrease in saliva secretion, frequently leading to dry mouth, ...

5. saliwell.com saliwell.com/three-promising-developments-for-treating-radiation-induced-xerostomia/

Three Promising Developments For Treating Radiation ... Non-clinical studies have already demonstrated a favorable risk and benefit profile of RXRG001 in animal models. This new study hopes to shed ...

6. prnewswire.com prnewswire.com/news-releases/ribox-therapeutics-announces-fda-clearance-for-ind-application-of-rxrg001-the-first-circular-rna-therapy-for-the-treatment-of-radiation-induced-xerostomia-and-hyposalivation-302287539.html

RiboX Therapeutics Announces FDA Clearance for IND ... The first-in-human SPRINX-1 study is designed to evaluate the safety and efficacy of RXRG001 in patients with radiation-induced-xerostomia (RIX) (dry mouth) ...

7. trialx.com trialx.com/clinical-trials/listings/308968/study-of-circular-rna-treatment-in-patients-with-radiation-induced-xerostomia-1/

Study of Circular RNA Treatment in Patients With Radiation ... This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 ... xerostomia (dry mouth) and hyposalivation ...

8. withpower.com withpower.com/trial/rxrg001-for-dry-mouth-2d2d9

RXRG001 for Dry Mouth (SPRINX-1 Trial) This is a first-in-human clinical study to evaluate the safety, tolerability and efficacy of RXRG001 administered in the ducts of the parotid glands in ...