Clinical trials are fantastic ways to develop a deeper understanding of a specific disease, as well as determine the safety, efficacy, and tolerability of potential treatments. Unfortunately, these treatments are not always successful. According to Pulmonology Advisor, researchers were evaluating BAY2253651 for obstructive sleep apnea within the Phase 2 SANDMAN clinical trial. Promisingly, BAY2253651 was relatively safe and well-tolerated. However, researchers found that there was so significant therapeutic effect, rendering the treatment ineffective. Because of this, the SANDMAN trial was stopped.
Interested in learning more? Take a look at some of the research findings published in the European Respiratory Journal.
BAY2253651
So what exactly is BAY2253651? The treatment was a nasally-administered potassium channel inhibitor designed to target and activate the genioglossus muscle. Through this, BAY2253651 helped improve the reflex activity in the upper airway, allowing for easier and better breathing. Researchers were excited for BAY2253651. Although surgery, implants, and medical devices can assist with obstructive sleep apnea, there are no pharmacological therapies.
Altogether, 34 adult patients with obstructive sleep apnea enrolled in the trial. Patients had been using CPAP machines for 3+ months at the time of enrollment. At first, patients received either 100mg BAY2253651 or a placebo. However, in the latter half of the trial, all patients received 100mg BAY2253651. The response rate was fairly similar (separated by only 0.4%), with a higher response actually recorded for the placebo.
Researchers do acknowledge that the study was relatively small and are looking to continue evaluating a similar compound moving forward. However, for now, it seems as though BAY2253651 does not offer any significant benefits to patients.
Obstructive Sleep Apnea (OSA)
Obstructive sleep apnea is considered a sleep disorder, characterized by breathing which repeatedly stops and starts while sleeping. It occurs when muscles which support soft tissues in the throat temporarily relax, but they relax too much. As a result, the throat muscles block the airway, interrupting breathing. Although obstructive sleep apnea can occur in people of all ages, the incidence tends to increase with age. Other risk factors include being male, being overweight, having a family history of sleep apnea, smoking tobacco, having diabetes or chronic nasal congestion, or being overweight. Symptoms include:
- Excessive daytime sleepiness
- Dry mouth and/or sore throat
- High blood pressure
- Snoring
- Abrupt awakenings and sleep disruptions caused by gasping or choking
- Headaches in the morning
- Changes in mood
- Lowered libido
- Difficulty concentrating
- Night sweats
