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Ensifentrine twice daily · 1 trial · 1 indication
Responders are defined as an improvement (decrease) from baseline of ≥2 points. The COPD Assessment Test(tm) (CAT) is a one-page, 8-item questionnaire suitable for completion by patients diagnosed with COPD. When completing the questionnaire, individuals rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment) with a scoring range of 0-40. Higher scores indicate greater disease impact. The individual items are: Cough, Mucus, Chest Tight, Breathless, Limited Activities, Confident, Sleep and Energy). CAT was self-completed at baseline, week 6 and week 12.
| Arm | Type | Description |
|---|---|---|
| Ensifentrine | EXPERIMENTAL | Inhaled ensifentrine twice daily for 12 weeks via standard jet nebulizer in addition to standard dual (LAMA/LABA) or triple (LAMA/LABA/ICS) COPD therapy. |
| Name | Type | Description |
|---|---|---|
| Ensifentrine 3 mg twice daily | DRUG | All subjects will receive ensifentrine. |
Inclusion Criteria: * Capable of giving informed consent. * Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years. * Established clinical history of moderate to severe COPD. * Pre- and post-albuterol FEV1/FVC ratio of \< 0.70. * Post-albuterol FEV1 ≥ 30 % and ≤ 75%...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 5 | PHASE3 | Depemokimab |
| Sanofi SA Sponsored ADR | SNY | 7 | PHASE3 | Itepekimab |
| AstraZeneca PLC | AZN | 14 | PHASE3 | Tezepelumab |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Alpha-1 MP |
| Pfizer Inc. | PFE | 1 | PHASE2 | PF-07275315 dose 1 |
| Merck & Co., Inc. | MRK | 2 | PHASE2 | Frespaciguat |
| Upstream Bio, Inc. | UPB | 1 | PHASE2 | Verekitug |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE3 | 611 |
| Generate Biomedicines, Inc. | GENB | 1 | PHASE1 | GB-0895 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | Treprostinil |
| Pulmonx Corp. | LUNG | 3 | - | Undisclosed |
| Baxter International Inc. | BAX | 1 | N/A | Undisclosed |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | EARLY_PHASE1 | Undisclosed |
Ensifentrine twice daily is an investigational small molecule being studied for the treatment of COPD, or chronic obstructive pulmonary disease. It is administered twice daily and is currently in Phase 3 clinical development. The drug is not yet approved and remains under investigation for this respiratory condition.
Ensifentrine twice daily is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this small molecule for the treatment of COPD, with the drug currently in Phase 3 development.
Ensifentrine twice daily is in Phase 3 clinical development for the treatment of COPD. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.
Ensifentrine twice daily has one completed Phase 3 clinical trial registered under NCT06460493, titled "Effect of Ensifentrine Treatment on CAT Score." This study enrolled 20 participants with COPD in the United States, with a minimum age of 40 years, and included both sexes.
Ensifentrine twice daily refers to the dosing regimen of the drug Ensifentrine, which is administered twice a day. The clinical trial NCT06460493 evaluates the effect of this twice-daily treatment on the CAT score in patients with COPD. It is the same active compound, with the dosing frequency specified.