Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Beraprost modified release · 4 trials · 1 indication
The change in Pulmonary Vascular Resistance (PVR) was evaluated from Baseline to Week 12. PVR is expressed in Wood Units or millimeters of Mercury per Liter per minute (mmHG/L/min)
The change in Cardiac Output was evaluated from Baseline to Week 12.
The change in mean Pulmonary Arterial Pressure (mPAP) was evaluated from Baseline to Week 12.
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-204 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted.
A treatment-emergent adverse event (TEAEs) is defined as an event not present prior to the initiation of the treatments or any event already present that worsens in either intensity or frequency following exposure to the treatments. AEs occurring more than 3 days after the last day study drug is taken in the study will not be included in the statistical analyses or summaries (except for subjects with adverse events leading to study drug withdrawn). Only treatment-emergent adverse events occurring during the treatment period of the BPS-MR-PAH-202 study will be summarized. Any adverse event starting prior to the first dose of study drug will be excluded from the summary analyses and only presented in the data listings. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
A treatment-emergent adverse event (TEAE) is defined as an event not present prior to the initiation of the treatment or any event already present that worsens in either intensity or frequency following exposure to the treatment. AEs occurring more than 3 days after the last day study drug was taken in the study was not included in the statistical analyses or summaries (except for participants with adverse events leading to study drug withdrawn). Only TEAEs that occurred during the treatment period of the BPS-MR-PAH-202 study were summarized. Any adverse event starting prior to the first dose of study drug was excluded from the summary analyses and only presented in the data listings. All efficacy results are descriptive; no statistical analysis was conducted. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Arm | Type | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) | EXPERIMENTAL | Patients in the MTD treatment group will dose escalate weekly by 60µg b.i.d. until they reach the maximum dose of 600µg b.i.d. or they reach an intolerable dose which requires them to down-titrate by 60µg b.i.d. In these instances and at the Investigator's discretion, further attempts at dose escalation may be made. |
| Low Fixed Dose | EXPERIMENTAL | The low dose group will receive 60µg twice a day(b.i.d.) |
| High Fixed Dose | EXPERIMENTAL | Patients in the high dose group will dose escalate weekly by 60µg twice a day (b.i.d.) until they reach the fixed dose of 240µg b.i.d. Once patients in these treatment groups have reached their assigned maximum dose of active drug, |
| B.I.D | EXPERIMENTAL | Beraprost Sodium Modified Release Tablet, 60mcg, B.I.D (twice a day dosing) |
| Q.I.D | EXPERIMENTAL | Beraprost Sodium Modified Release Tablet, 60mcg, q.i.d (four times a day dosing) |
| Name | Type | Description |
|---|---|---|
| Beraprost Sodium Modified Release | DRUG | 60µg Tablets, twice a day for 12 weeks |
Inclusion Criteria: 1. IRB approved written informed consent has been obtained. 2. Male or female, age 18 to 75 years (inclusive). 3. Established diagnosis of pulmonary arterial hypertension that is either idiopathic or familial PAH, collagen vascular disease associated PAH, PAH induced by anorexig...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| United Therapeutics Corporation | UTHR | 5 | PHASE3 | Ralinepag |
| Merck & Co., Inc. | MRK | 6 | PHASE3 | Riociguat |
| Insmed Incorporated | INSM | 4 | PHASE3 | Treprostinil Palmitil |
| Johnson & Johnson | JNJ | 4 | PHASE3 | Selexipag |
| Liquidia Corporation | LQDA | 4 | PHASE3 | L606 |
| Tenax Therapeutics, Inc. | TENX | 3 | PHASE3 | TNX-103 |
| Inhibikase Therapeutics, Inc. | IKT | 1 | PHASE3 | IKT-001 |
| Gossamer Bio, Inc. | GOSS | 2 | PHASE3 | Seralutinib |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | REGN13335 |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07868489 |
| Tectonic Therapeutic Inc | TECX | 1 | PHASE2 | TX000045- Dose A, TX000045- Dose B |
| Abbott Laboratories | ABT | 1 | N/A | Undisclosed |
Beraprost modified release is an investigational small molecule being developed for the treatment of Pulmonary Arterial Hypertension (PAH). It is a prostacyclin analogue that has been studied in Phase 2 clinical trials. The drug is not approved and remains in clinical development.
Beraprost modified release is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker UTHR. The company has sponsored multiple clinical trials of the drug in patients with Pulmonary Arterial Hypertension.
Beraprost modified release is in Phase 2 clinical development. It has completed four Phase 2 trials, with no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities for any indication.
Beraprost modified release has been studied in four completed Phase 2 trials: NCT00781885, a dose-finding study; NCT00792571, an open-label extension; NCT00989963, a dose-response study; and NCT00990314, another extension study. These trials enrolled a total of 104 patients with Pulmonary Arterial Hypertension.
Beraprost modified release is a prostacyclin analogue, which means it mimics the action of prostacyclin, a naturally occurring molecule that dilates blood vessels and inhibits platelet aggregation. In Pulmonary Arterial Hypertension, this helps reduce pulmonary artery pressure and improve exercise capacity.
Beraprost modified release is a modified release formulation of beraprost sodium, also known as BPS-MR. The clinical trials for this drug specifically studied the modified release version, which is designed to provide a more sustained effect compared to immediate release formulations.