Telaglenastat for Pulmonary Hypertension

(TEPH Trial)

Overseen By Michael Risbano, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Chan, Stephen, MD, PhD

Must be taking: Vasodilators, Sotatercept

Must not be taking: Antidepressants, others

Disqualifiers: Heart failure, Hypertension, Sleep apnea, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, Telaglenastat, to determine its effectiveness for people with Pulmonary Hypertension (PH), a condition affecting lung blood vessels that can lead to heart problems. Researchers aim for Telaglenastat to lower lung blood pressure and improve heart and lung function. Individuals diagnosed with PH who experience symptoms impacting daily life, such as shortness of breath or fatigue, might qualify for this trial. As a Phase 1 and Phase 2 trial, the study focuses on understanding how Telaglenastat works in people and measuring its effectiveness in an initial group, offering participants a chance to be among the first to benefit from this potential treatment.

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

The trial does not specify if you need to stop your current medications. However, for certain groups, you must be on a stable dose of your current treatment for at least 30 days before joining the trial.

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

Research has shown that Telaglenastat has been tested primarily for cancer treatment. Although the FDA has not yet approved it for pulmonary hypertension, previous studies in other conditions offer some insight into its safety. In these studies, patients generally tolerated Telaglenastat well, with few serious side effects. This suggests it might be safe for people with pulmonary hypertension, but further research is necessary to confirm this. Current studies, still in the early stages, focus on ensuring the drug's safety and determining the correct dose. Additional data will help confirm these early safety findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Pulmonary Hypertension?

Unlike the standard treatments for pulmonary hypertension, which often include medications like endothelin receptor antagonists, phosphodiesterase-5 inhibitors, and prostacyclin analogs, telaglenastat offers a novel approach. It is unique because it targets cancer metabolism by inhibiting glutaminase, an enzyme crucial for cellular energy production. Researchers are excited about telaglenastat because this new mechanism of action might offer a more effective way to manage pulmonary hypertension, potentially improving outcomes for patients who don't respond well to existing therapies.

What evidence suggests that Telaglenastat might be an effective treatment for Pulmonary Hypertension?

Research has shown that Telaglenastat might help lower high blood pressure in the lungs and improve heart and lung function in people with pulmonary hypertension (PH). This drug blocks a protein called glutaminase, which can damage the heart and blood vessels. By inhibiting this protein, Telaglenastat may reduce the damage leading to PH. Although promising, it remains under study in this trial and is not yet approved for treating this condition. Early results are encouraging, but further research is needed to confirm its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Risbano, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Adults with Pulmonary Hypertension, a condition affecting the arteries in the lungs, can join this study. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded for various medical reasons.

Inclusion Criteria

Able to provide written informed consent

Able to comply with study procedures, able to undergo cardiac catheterization and exercise testing

Patients will be identified with PH Group 1-4 PH by an expert clinician in the UPMC Comprehensive Care Center for Pulmonary Hypertension

Exclusion Criteria

Group 1 PH, patients naïve to medical treatment for PH are not eligible for enrollment

Enrolled in, or planned participation in, device or other interventional clinical studies or cardio-pulmonary rehabilitation programs, based upon exercise within 90 days of Screening or during study participation

Left ventricular ejection fraction (LVEF) < 45%

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit (30-60 mins)

1 visit (in-person)

Baseline

Baseline assessments including physical exam, 6-minute walk test, and various imaging and lab tests

1 visit (2-3 hours)

1 visit (in-person)

Treatment

Participants receive Telaglenastat 800 mg/twice daily with regular monitoring

12 weeks

4 visits (in-person) at weeks 1, 2, 4, and 8

End of Treatment

Final assessments including physical exam, 6-minute walk test, and various imaging and lab tests

1 visit (2-3 hours)

1 visit (in-person) at week 12

Optional Extension

Continuation of treatment with the same procedures as the initial 12 weeks

12 weeks

5 visits (in-person) at weeks 13, 16, 20, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Telaglenastat

Trial Overview The trial is testing Telaglenastat's effectiveness on Pulmonary Hypertension. This drug aims to lower lung blood pressure and improve heart and lung function. It's an investigational medication not yet approved by the FDA.

How Is the Trial Designed?

Group I: Open-Label Telaglenastat Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Chan, Stephen, MD, PhD

Lead Sponsor

Synhale Theraputics

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223528

TEPH: Telaglenastat Efficacy in Pulmonary Hypertension However, the study investigators believe that Telaglenastat may help lower blood pressure in the lungs and improve both heart and lung function.

2. withpower.com withpower.com/trial/phase-2-hypertension-pulmonary-10-2025-4cfbc

Telaglenastat for Pulmonary Hypertension (TEPH Trial) However, the study investigators believe that Telaglenastat may help lower blood pressure in the lungs and improve both heart and lung function. It is important ...

3. pulmonaryhypertensionnews.com pulmonaryhypertensionnews.com/news/synhale-acquires-telaglenastat-plans-ph-trial/

Synhale acquires telaglenastat, plans ... Telaglenastat is a compound that targets a protein called glutaminase, which is a driver of cardiac, blood vessel, and pulmonary damage. Data ...

4. synapse.patsnap.com synapse.patsnap.com/article/synhale-therapeutics-acquires-telaglenastat-to-speed-up-pulmonary-hypertension-treatment

Synhale Therapeutics Acquires Telaglenastat to Speed Up ... PH associated with HFpEF has a five-year mortality rate nearing 50%, a statistic that mirrors the grim outcomes in chronic obstructive pulmonary ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11551874/

Viewing Pulmonary Arterial Hypertension Pathogenesis and ... Prior reports have identified a distinct metabolic profile related to RV function and outcomes in PAH patients, including heightened FDG glucose ...

6. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07223528

Telaglenastat in Pulmonary Hypertension - Clinical Trials Registry ... The research study is being conducted to evaluate the effectiveness of a drug called Telaglenastat in adults diagnosed with Pulmonary Hypertension (PH).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7691927/

Long-term outcomes in pulmonary arterial hypertension by ... Survival rates for functional class I/II patients at one, two, and three years were 93% (95% confidence interval (CI): 91%–95%), 86% (95% CI: 82%–89%), and 78% ...