Approval Probability
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Adjusted LOA
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BAY2586116 · 3 trials · 2 indications
A response is defined as reduction of apnea-hypopnea index (AHI) from baseline by ≥50%
| Arm | Type | Description |
|---|---|---|
| BAY2586116_Placebo | EXPERIMENTAL | Male or female participants aged above or equal to 18 years diagnosed with moderate to severe OSA will be allocated randomly to this intervention sequence. Participants will receive BAY2586116 in treatment period 1, and placebo in treatment period 2. Each intervention will be applied at home for 6 days (+1 optional day) followed by one in-house application for the overnight PSG (polysomnography). In total, each participant will receive up to a maximum of 7 single doses (8 single doses if optional day is used) of BAY2586116 and up to 7 single doses of placebo (8 single doses if optional day is used). |
| Placebo_BAY2586116 | EXPERIMENTAL | Male or female participants aged above or equal to 18 years diagnosed with moderate to severe OSA will be allocated randomly to this intervention sequence. Participants will receive placebo in treatment period 1, and BAY2586116 in treatment period 2. Each intervention will be applied at home for 6 days (+1 optional day) followed by one in-house application for the overnight PSG. In total, each participant will receive up to a maximum of 7 single doses (8 single doses if optional day is used) of BAY2586116 and up to 7 single doses of placebo (8 single doses if optional day is used). |
| Part A: A1A2+Part B+Part C | EXPERIMENTAL | Part A: Participants will receive a single dose administration of BAY2586116 (A1) in treatment period 1, and a single dose administration of placebo (A2) in treatment period 2. Part B: After successfully completing Part A, participants will proceed to Part B of the study. Participants will receive a single dose administration of BAY2586116 (B1) in treatment period 3. Based on the result of the interim analysis there are two possible scenarios regarding mode of application and doses of BAY2586116 to be administered in treatment period 4: 1) a single dose administration of BAY2586116 (B2) Or 2) a single dose administration of BAY2586116 (B3). Part C: Participants completing Part B will be invited to participate in an additional treatment period with a single dose BAY2586116 (C). |
| Part A: A2A1+Part B+Part C | EXPERIMENTAL | Part A: Participants will receive a single dose administration of placebo (A2) in treatment period 1, and a single dose administration of BAY2586116 (A1) in treatment period 2. Part B: After successfully completing Part A, participants will proceed to Part B of the study. Participants will receive a single dose administration of BAY2586116 (B1) in treatment period 3. Based on the result of the interim analysis there are two possible scenarios regarding mode of application and doses of BAY2586116 to be administered in treatment period 4: 1) a single dose administration of BAY2586116 (B2) Or 2) a single dose administration of BAY2586116 (B3). Part C: Participants completing Part B will be invited to participate in an additional treatment period with a single dose BAY2586116 (C). |
| BAY2586116 Dose step 1 and Placebo | EXPERIMENTAL | Each participant of Dose step 1 will receive a single dose of BAY2586116 or placebo. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). |
| BAY2586116 Dose step 2 and Placebo | EXPERIMENTAL | Each participant of Dose step 2 will receive a single dose of BAY2586116 or placebo. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). |
| BAY2586116 Dose step 3 and Placebo | EXPERIMENTAL | Each participant of Dose step 3 will receive single and multiple doses of BAY2586116 or placebo administered once daily (OD) for 5 consecutive days. In this dose step, 12 participants will be included (9 on active treatment, 3 on placebo). |
| Name | Type | Description |
|---|---|---|
| BAY2586116 | DRUG | 160 µg, nasal spray administration. |
| Placebo | DRUG | Placebo matching BAY2586116, nasal spray administration. |
| BAY2586116 (A1) | DRUG | 160 μg BAY2586116 (nasal spray administration) |
| Placebo (A2) | DRUG | Placebo matching BAY2586116 (nasal spray administration) |
| BAY2586116 (B1) | DRUG | 160 μg BAY2586116 (nasal drops) |
| BAY2586116 (B2) | DRUG | 80 μg BAY2586116 (nasal spray) |
| BAY2586116 (B3) | DRUG | 160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril) |
| BAY2586116 (C) | DRUG | 160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril). It is the same procedure as described under part B3. |
Inclusion Criteria: * A participant must be at least 18 years of age, at the time of signing the informed consent. * Participants need to be diagnosed with OSA. * 15 ≤ AHI ≤ 60 per hour documented by baseline PSG (evaluated by NOX software; manual overreading by site staff possible) and after ≥72 h...
BAY2586116 is an investigational small molecule being developed for obstructive sleep apnea, a sleep disorder caused by narrowing and collapse of the airway during sleep. It is being studied in patients with moderate to severe obstructive sleep apnea. The drug is in clinical development and is not yet approved by regulatory authorities.
BAY2586116 is being developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical trials to evaluate the safety and efficacy of BAY2586116 in patients with obstructive sleep apnea.
BAY2586116 is in Phase 1 and Phase 2 clinical development. Two Phase 2 trials have been completed, along with one Phase 1 trial in healthy volunteers. The drug is investigational and remains in clinical development, meaning it has not received regulatory approval for any use.
BAY2586116 has been studied in three completed clinical trials. NCT04236440 and NCT04713826 were Phase 2 trials in patients with obstructive sleep apnea, conducted in Australia, Germany, and Switzerland. NCT04872387 was a Phase 1 trial in healthy Japanese male participants. All trials are completed.
BAY2586116 is a small molecule being studied for obstructive sleep apnea. The specific molecular target of BAY2586116 has not been disclosed in available clinical trial information. The drug is administered through the nose, as indicated by the intranasal route of administration in clinical studies.
BAY2586116 is the only name provided for this investigational drug. No alternative names or brand names have been disclosed in the available clinical trial information. The drug is identified solely by its development code BAY2586116 in all registered clinical studies.