According to an article from Pharmaceutical Daily, the Seattle-based drug company Sound Pharmaceuticals is set to soon begin a phase 2 clinical study for a cystic fibrosis (CF) drug candidate designed to counteract the hearing loss that can accompany certain CF treatments.
Cystic Fibrosis and Hearing Loss
Cystic fibrosis is a lung disorder that is typically genetically inherited. It causes the mucous that the body produces as a natural lining for some organs to become thick and viscous, which can create blockages. It’s a serious condition and can lead to severe complications – the life expectancy of the average CF patient is still only around 40 years.
However, cystic fibrosis itself seems to have little effect, if any, on the fluids in the ear. So where does the connection between cystic fibrosis and hearing loss originate?
In certain instances when the symptoms of cystic fibrosis worsen unexpectedly and in a short amount of time, antibiotics called aminoglycosides will be administered, often intravenously. Physicians call such episodes acute pulmonary exacerbations.
While no connection has been found between CF and hearing loss itself, aminoglycosides, especially when introduced intravenously, are thought to be linked to hearing loss.
About SPI-1005
Tobramycin is one such aminoglycoside.
In their upcoming phase 2 trial, which they expect to take place around sometime midyear, Sound Pharmaceuticals will be administering tobramycin to patients experiencing acute pulmonary exacerbations – along with their experimental drug SPI-1005.
Calling SPI-1005 a cystic fibrosis drug feels somewhat misleading. It is in equal parts a tobramycin drug, as researchers hope the experimental pharmaceutical will counteract the symptomatic hearing loss experienced by some aminoglycoside patients.
The trial will involve some 100 patients over a period of roughly two months. Participants will have their hearing and general health examined before beginning a 3-week regimen of typical daily tobramycin doses. Within two days of beginning the tobramycin treatment, SPI-1005 will be administered daily and simultaneously. At the end of treatment, and again a month later, patients’ hearing and general health will be reassessed.
The administration of SPI-1005 will vary to determine ideal dosage.
Most drug candidates stall around phase 2 of clinical testing. This phase is primarily concerned with proving the efficacy of a drug in treating its targeted condition – in other words, scientists will be trying to prove that their product actually works.
Currently, no treatment exists for this kind of hearing loss – which can be temporary or sometimes permanent. Researchers are eager for a breakthrough, but much work remains to be done.
Some medications can lead to new conditions almost as serious as those they hope to treat. It can be difficult to try and “cure” a side effect. Do you think it’s better to avoid a particular treatment, or develop new medications to reckon with the consequences? Share your thoughts with Patient Worthy!
