DSP-3077 for Retinitis Pigmentosa

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sumitomo Pharma America, Inc.

Must not be taking: Experimental therapies

Disqualifiers: Eye disease, Pregnancy, Unstable condition, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called DSP-3077 for individuals with retinitis pigmentosa, a condition that gradually leads to vision loss. The main goal is to assess the safety and tolerability of this treatment when administered in a single dose and to evaluate its effects on vision. Participants are divided into three groups based on their vision levels to test different doses. This trial may suit those with a confirmed diagnosis of retinitis pigmentosa who experience significant vision loss in one eye. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have participated in another clinical trial or received experimental treatment for an eye condition recently, you may not be eligible.

Is there any evidence suggesting that DSP-3077 is likely to be safe for humans?

Research has shown that DSP-3077 is undergoing safety testing for retinitis pigmentosa, a condition that causes vision loss. In related studies, patients have received a single injection of DSP-3077 in one eye. The treatment remains in the early testing stages, focusing primarily on safety and the body's reaction to the drug. Detailed safety information is still limited due to the early phase of testing. However, these initial tests help researchers identify any side effects and assess their severity, ensuring the treatment's safety for future use.

Specific safety results are not yet available, so potential trial participants should understand that discovering this information is a key study goal. This phase indicates that while the treatment has passed initial lab tests, its safety in humans is still under careful examination. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for retinitis pigmentosa?

Researchers are excited about DSP-3077 for retinitis pigmentosa because it offers a novel approach compared to existing treatments. While most current options, like vitamin A supplements and vision aids, focus on slowing progression or managing symptoms, DSP-3077 targets the underlying mechanisms of the disease. This treatment is designed to improve visual acuity by potentially restoring some degree of sight, rather than just preserving existing vision. This innovative mechanism gives hope for enhanced outcomes in patients with varying degrees of vision loss.

What evidence suggests that DSP-3077 might be an effective treatment for Retinitis Pigmentosa?

Research has shown that DSP-3077 could be a promising treatment for retinitis pigmentosa, a disease that causes vision loss. This treatment uses special sheets made from stem cells to replace damaged cells in the eye. Early results suggest these stem cell therapies might slow the disease and help restore some vision. Although still in the early stages, this approach offers hope for people with retinal diseases once thought untreatable. In this trial, participants will be divided into different cohorts to assess their tolerance of DSP-3077 and any improvements in vision. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with retinitis pigmentosa, who are willing to undergo genetic testing. Participants must have specific levels of visual acuity depending on the cohort they're assigned to. They should be in good health as determined by medical history, exams, and various tests.

Inclusion Criteria

I am willing to undergo genetic testing.

I have been diagnosed with nonsyndromic retinitis pigmentosa.

My vision in the study eye is very poor, between hand motion and seeing big letters.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subretinal uniocular injection of DSP-3077

2 weeks

Frequent visits

Initial Follow-up

Participants are monitored monthly through Month 4 after treatment

4 months

Monthly visits

Extended Follow-up

Participants are monitored every 3 months through Month 24 and every 6 months through Month 60

56 months

Every 3 months, then every 6 months

Long-term Follow-up

Long-term safety data collection annually from 6 years to 15 years after DSP-3077 administration

9 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• DSP-3077

Trial Overview The study is testing the safety and effects of a single dose of DSP-3077 delivered via an eye injection. It's divided into three cohorts based on vision sharpness and dosage level, with each group having four participants.

How Is the Trial Designed?

Group I: Cohort 3 Experimental Treatment 1 Intervention

Best Corrected Visual Acuity (BCVA) in the study eye between 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≥ 20/400 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20/200 Snellen equivalent), inclusive at Screening; BCVA in the study eye between 10 ETDRS letter score (approximately ≥ 20/640 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20/200 Snellen equivalent) at Baseline

Group II: Cohort 2 Experimental Treatment 1 Intervention

Best Corrected Visual Acuity (BCVA) in the study eye between hand motion and 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/400 Snellen equivalent), inclusive at Screening and Baseline

Group III: Cohort 1 Experimental Treatment 1 Intervention

Best Corrected Visual Acuity (BCVA) in the study eye between hand motion and 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20/400 Snellen equivalent), inclusive at Screening and Baseline

Who Is Running the Clinical Trial?

Sumitomo Pharma America, Inc.

Lead Sponsor

Trials

244

Recruited

51,500+

Jatin Shah

Sumitomo Pharma America, Inc.

Chief Medical Officer since 2024

MD from an unspecified institution

Tsutomu Nakagawa

Sumitomo Pharma America, Inc.

Chief Executive Officer since 2024

MBA from Waseda University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06891885

A Study to Investigate the Safety of DSP-3077 After ... Study Overview​​ The Goal of this study is to evaluate the safety, tolerability, and clinical responses following single dose of DSP-3077. Study enrolls both ...

2. sumitomo-pharma.com sumitomo-pharma.com/news/20241129.html

Initiation of Phase1/2 Study on Allogeneic iPS Cell-derived ... Sumitomo Pharma will conduct the clinical study with the objective of offering a new treatment option to retinitis pigmentosa patients as early as possible.

3. araceagainstblindness.org araceagainstblindness.org/blogs/news/stem-cell-derived-retinal-sheets-enter-clinical-trial-for-retinitis-pigmentosa?srsltid=AfmBOopTjnkFEMGWF3dwY5Ofuy3GPBXwPIML3xB7fMiW4u5qQL4hiE-C

Stem Cell–Derived Retinal Sheets for RP Trial While much work remains, DSP-3077 highlights the growing promise of stem cell–based therapies in tackling retinal diseases once considered ...

4. withpower.com withpower.com/clinical-trials/for-retinitis-pigmentosa?page=2

Top Retinitis Pigmentosa Clinical Trials | Power The Goal of this study is to evaluate the safety, tolerability, and clinical responses following single dose of DSP-3077. Study enrolls both male and female ...

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0056216

Retinitis Pigmentosa (RP) (DBCOND0056216) - DrugBank A Study to Investigate the Safety of DSP-3077 After a Unilateral Eye Injection in Male and Female Participants 18 Years of Age or Older with Retinitis ...

6. araceagainstblindness.org araceagainstblindness.org/blogs/news/stem-cell-derived-retinal-sheets-enter-clinical-trial-for-retinitis-pigmentosa?srsltid=AfmBOoqDdn1GBpgR_UmDwdyx0IQX4TA83gzyG44HgLqdGAhyJRN3fkb0

Stem Cell–Derived Retinal Sheets for RP Trial Stem Cell–Derived Retinal Sheets enter clinical trial for Retinitis Pigmentosa, exploring new hope for patients with regenerative therapy.

7. app.trialscreen.org app.trialscreen.org/trials/phase-1-2-to-investigate-safety-dsp-3077-after-unilateral-eye-injection-trial-nct06891885

A Study to Investigate the Safety of DSP-3077 After ... Participants in this study will receive an investigational cell therapy that has the potential to improve vision or slow the progression of vision loss in ...

8. synapse.patsnap.com synapse.patsnap.com/drug/f65ea31625644ee6a31987f008ef31ce

DSP-3077 - Drug Targets, Indications, Patents A Prospective, Open-label, Single-arm, Dose-escalation Study of the Safety and Tolerability of a Single Subretinal Uniocular Injection of Allogeneic Induced ...