Sleep apnea is a potentially deadly condition. It can kill through cardiovascular complications, dementia, cancer, kidney failure, and even car accidents. Fortunately, sleep apnea is treatable. Unfortunately, the most-prescribed sleep apnea treatment, CPAP, only helps about half of the patients prescribed. That’s because people find the treatment uncomfortable and inconvenient, so they don’t use it long-term.
This drives a quest for CPAP alternatives, including a newly developed sleep apnea drug. This drug is not yet available, and we don’t know when it will be available, but it passed two major milestones recently.
Although preliminary data seems promising to investors, it seems like the new drug isn’t as effective as the already-available CPAP alternative: oral appliance therapy. If you are looking for a CPAP alternative in Omaha, you don’t have to wait. Instead, contact the Advanced Dental Sleep Treatment Center today to learn if you’re a candidate for oral appliance therapy.
New Drug Readies for Phase 3 Trials
Currently known only as “AD109,” the sleep apnea drug showed promise in its Phase 2 clinical trial. Now the drugmaker, Apnimed, is preparing to move into Phase 3 development after one more Phase 2 trial.
We’ll provide a basic rundown of the normal clinical phases of drug development to help you understand how important this is.
In Phase 1, researchers look mostly at the safety of the drug. Typically involving a few dozen volunteers (which might include both healthy individuals and those with the targeted condition), researchers make sure the drug doesn’t have any deadly effects and try to hone in on a potential dosage. Approximately 70% of drugs move past Phase 1.
In Phase 2, researchers want to see if the drug really works. Using from one to a few potential dosages determined in Phase 1, up to several hundred participants take the drug between months and years. In addition to checking efficacy, researchers look for any concerning side effects triggered by the potential doses. Approximately 33% of drugs pass Phase 2.
In Phase 3, there may be thousands of people taking the developmental drug. Studies take from 1 to 4 years to look at long-term efficacy and safety. About 25% of drugs make it past Phase 3.
After Phase 3, a manufacturer can request marketing approval from the FDA. The FDA evaluates all the clinical trials as well as the need for the drug before approving it.
Once approved, a drug moves on to Phase 4, also known as Postmarket Monitoring. Large studies and reports to the FDA look for adverse effects. If sufficient safety concerns arise, the FDA might decide to pull the drug from the market.
Based on this timetable, AD109 might be as little as 2-5 years away from pharmacy shelves in Omaha.
Manufacturer Secures Funding
Of course, in order to take a drug to development, biotech companies need funding. The other big news about this sleep apnea drug is that Apnimed’s funding is growing rapidly.
Here’s how funding typically works for biotech companies.
Funding starts with an initial investment in the seed round. Researchers have an idea, but they need to show that it could work. Friends, family, grants, and angel investors typically supply this money.
Once a researcher proves a drug or therapeutic principle, they will usually seek to form a company to shepherd it from principle to market. They do this by requesting Series A round funding. Investors at this phase gain some influence over the direction of the development of the drug or treatment.
Series B/C/D rounds help the new company to move the drug or therapy through the clinical trial phases, increasing in size as the trials do. At any point, a large biotech company might also decide to purchase the start-up and take over development. Or the company might decide they’re ready for an initial public offering (IPO) where they publicly sell stock in the company.
Apnimed recently announced the results of its Series C funding round: $62.5 million. While this is far from the largest Series C funding round, it represents a huge increase over the company’s Series B funding of $25 million.
Much of the increase in funding likely comes because of the positive results of Phase 2 trials.
How Effective Is Sleep Apnea Drug?
So, how effective is this new drug that Apnimed is developing? It combines a selective norepinephrine reuptake inhibitor with a new special drug that stimulates the muscles in the airway.
Currently, released data comes from just a very small clinical trial. In this trial, 32 patients received a placebo and two different doses of AD109 in random order over three nights. Mostly, the company measured results using an endpoint of their own design. However, they also reported the impact of the drug on the apnea-hypopnea index (AHI), a measure of the number of times breathing stopped or decreased.
Patients had a median AHI of 13.2 when taking a placebo. However, when they took the low dose of AD109, the AHI dropped to 7.8. On the high dose of AD109, the AHI dropped to a median of 5.5. This is a statistically significant difference, but it is not as much as might be hoped. All these AHI numbers correspond to mild sleep apnea. In order to stand as an alternative to CPAP for people in Omaha, the drug will have to effectively treat more serious sleep apnea.
Get a CPAP Alternative in Omaha
For many people, CPAP is a powerful sleep apnea treatment. However, we need alternatives because so many people in Omaha cannot adapt to CPAP. Fortunately, an alternative already exists. Clinical trials often show that oral appliance therapy can match CPAP in overall effectiveness. While oral appliances can’t eliminate sleep apnea as reliably as CPAP, better compliance often leads to equivalent results.
Not everyone is a good candidate for oral appliance therapy, however. An Omaha sleep dentist can evaluate your condition to determine if oral appliance therapy will work for you.
To learn whether oral appliance therapy is right for you, please call (402) 493-4175 or use our online form to request an appointment at the Advanced Dental Sleep Treatment Center located in Omaha.
