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Also known as BAY2586116 (A1)
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 being developed for obstructive sleep apnea, a sleep disorder in which the airway narrows or collapses during sleep. It is an investigational small molecule from Bayer AG, studied in adults with moderate to severe obstructive sleep apnea as well as in healthy volunteers.
BAY2586116 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored all three of the clinical trials listed for the compound, including Phase 1 and Phase 2 studies conducted in Japan, Germany, Switzerland, and Australia.
BAY2586116 has reached Phase 2 clinical development. Three trials have been completed: one Phase 1 study in healthy Japanese male participants and two Phase 2 studies in participants with obstructive sleep apnea. No trials for BAY2586116 are currently listed as active.
Three completed trials cover BAY2586116: NCT04872387, a Phase 1 study of single and multiple nasal doses in 36 healthy Japanese men; NCT04713826, a Phase 2 trial in 93 participants with moderate to severe obstructive sleep apnea in Germany and Switzerland; and NCT04236440, a Phase 2 study in 14 participants in Australia.
Yes. BAY2586116 (A1) is an alternative designation used for BAY2586116, the Bayer AG small molecule in development for obstructive sleep apnea. Both names refer to the same investigational compound, so search results and trial records under either name describe the same drug.
Across the three completed BAY2586116 trials, 143 participants were enrolled in total. The Phase 1 study in Japan enrolled 36 healthy volunteers, while the two Phase 2 obstructive sleep apnea studies enrolled 93 participants in Germany and Switzerland and 14 participants in Australia.