Frequency Therapeutics- today released top-line data from an exploratory clinical study. The study aimed to show whether drug levels of FX-322 in the cochlea could be measured directly. In addition to confirming the feasibility of the method, the results of the study showed that each patient had measurable concentrations of FX-322 in his or her body, and Anatomical factors did not prevent FX-322 active agents from reaching the cochlea. In addition, levels of FX-322 in the cochlea were predicted to reach the therapeutically active range of the treatment.
FX-322 is the lead product candidate for Frequency, which is designed to regenerate auditory sensory hair cells in the cochlea, improve Hearing in patients with sensorineural deafness.A phase 1/2 study of FX-322 previously demonstrated hearing function in patients with SNHL Statistically significant and clinically meaningful improvements in key metrics.
This exploratory study started in late 2019 at the Hannover Medical Center in Hannover, Germany. The present results are based on the analysis of cochlear fluid, or external lymphatic fluid, obtained intraoperatively from cochlear implant surgery patients. Each patient received a single FX-322 tympanic injection, allowing researchers to directly measure FX-322 in the outer lymph fluid. 322 levels, which is not feasible in inner ear studies because access to the cochlea involves invasive surgery.
“When we consider these new findings, along with the auditory signals observed in our earlier phase 1/2 studies, we believe we have Develops the first known evidence for potential pharmacokinetic/pharmacodynamic effects of auditory restoration therapy. This study provided insight into the delivery properties of FX-322 and clinically confirmed it in all studies all played a role in the patients,” said Dr. Carl Lebel, Chief Development Officer of Frequency Corporation.
In the study, seven subjects received a single dose of FX-322 at dose levels comparable to the company’s Phase 1/2 study and its ongoing The dose levels were the same in the Phase 2a study conducted. The levels of the two molecules that make up FX-322 were measured in all patients. In some subjects, the presence of mucosal folds of the round window membrane did not prevent FX-322 from entering the cochlea. Based on computer models, the two drugs comprising FX-322 were also predicted to reach therapeutically active drugs in the high-frequency range of the cochlea. levels. Study subjects were followed up for approximately 30 days after surgery and no serious treatment-related adverse events were observed.
“Studying external lymphatic fluid samples from all of our cochlear implant patients helps us to better understand the connections between certain proteins and the their link to inner ear disease. This study now shows us, for the first time, that after injection within the tympanic cavity, concentrations of hearing restoration therapeutic candidates can be found in the outer lymphatic fluid Quantitative, we believe this new approach can help accelerate the understanding of inner ear therapeutics,” said Professor Thomas. Lenarz Ear Director, Ear, Nose and Throat Clinic German Audiology Center Hannover Medical School and the principal investigator of the study.
Frequency intends to present the results of this study at an upcoming medical conference.
About sensorineural hearing loss
Sensorineural hearing loss is the most common form of hearing loss and is usually caused by damage to the hair cells of the inner ear, which will The conversion of sound waves from the inner ear to the brain affects millions of people around the world. These auditory sensory hair cells may be lost due to prolonged exposure to noise, aging, certain viral infections or exposure to drugs that are toxic to the ear.
About Frequency Therapy
Frequency Therapy is a leader in the development of drugs for the activation of progenitor cells in the body to treat degenerative diseases. The company’s Progenitor Cell Activation (PCA) approach stimulates progenitor cells to produce functional tissue with the goal of developing disease-modifying therapies. The Company’s lead product candidate, FX-322, is designed to regenerate auditory hair cells to restore auditory function. In the FX-322 Phase 1/2 study, key indicators of hearing function in patients with sensorineural hearing loss were observed to be statistically Meaningful and clinically meaningful improvements.FX-322 is being evaluated in an ongoing Phase 2a study. The company is also evaluating its principal component analysis approach to generate functional tissue for other diseases, including multiple sclerosis discovery projects.