Frequency Therapeutics, a clinical stage biotechnology company, announced positive results from a Phase 1/2 safety trial to evaluate FX-322, an investigational drug candidate designed to facilitate hearing restoration. The trial assessed the safety of a single dose of FX-322 given by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who had a medical history consistent with either chronic noise exposure or idiopathic sudden sensorineural hearing loss. In the Phase 1/2 study, FX-322 was safe and well tolerated following a single intratympanic injection with no serious adverse events. In addition, improvements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.
“Hearing loss affects millions of people and current treatments are unable to restore hearing once it is lost,” said Susan Marenda King, MD, a neurotologist at the Ear Medical Group in San Antonio, Texas and lead enroller in the clinical trial. “The study results for FX-322, which show signs of functional hearing improvement, are very promising and represent an exciting step toward a potential treatment for patients.”
“While the focus of this study was safety, we are excited to see initial results in sensorineural hearing restoration as there are currently no treatments to restore hearing for these patients,” said David L. Lucchino, President, Co-founder and CEO of Frequency. “Furthermore, this data provides support for our small-molecule-driven regenerative medicine platform, which has the opportunity to address numerous degenerative diseases.”
Frequency plans to present the Phase 1/2 results at a major otolaryngology meeting in 2019 and to submit the results for publication. The company believes the results of this study support the advancement of FX-322 into a multiple dose Phase 2a study, which it plans to initiate later this year.
“If successful, our lead development program would represent the first time ever that hearing could be restored in humans with a therapeutic,” said Marc Cohen, Frequency’s Executive Chairman. “We are defining a new mode of regenerative medicine: activating progenitor cells within your body to repair damaged tissue.”
ABOUT THE FX-322 PHASE 1/2 TRIAL
The trial was a randomized, double-blind, placebo-controlled, single-dose, multi-center study to assess the safety of FX-322 in 23 patients with stable sensorineural hearing loss. Patients received an intratympanic injection of either a high-dose or low-dose volume of FX-322 or placebo in one ear. Patients were evaluated at an initial follow-up visit two weeks following injection and were monitored for three months. The trial was conducted at several leading otolaryngology clinics in San Antonio, Texas.
Information on the safety clinical trial can be found at clinicaltrials.gov with the identification number: NCT03616223.
Source: Frequency Therapeutics, NIH
I had snhl in 2017 but June 2020 was the first time I noticed a feeling like cotton in my ear with only high pitch loss of hearing per ENT hearing tests mri thyroid and no tmj dx and all tests are clear except for this irritating cotton feeling in my ear since June.per Mayo clinic, UNIVERSITY hospitals and ENT offices saying I do not qualify for your trials, please contact me (Linda O)if anyone can help with the new fx322.22 treatments per the NIH and frequency therapeutics that I have also contacted with no success to date
Help needed. Thank you
I am from China, 30 years old this year, deaf in both ears, I am looking forward to FX-322 research as soon as possible, enter the Chinese market, and return to normal life soon, thank you!
bonjour, je suis très heureux de savoir que enfin il y a une solution pour la perde auditive et je me porte volontaire de participer a cette essaie de FX-322, car j’ai une perte auditive aux deux oreilles a 40 ans je soufre beaucoup avec cette perte, svp Tenez-moi au courant des essais cliniques
This is an impressing invention and gives hope to millions of people affected by SNHL. I by myself am suffering also from this, I am using good hearing aids. With my age of 70 years I am not qualified for trials (age limit), but I hope I live long enough to get a regular medicament based on FX-322 injected.
I am 68 years old and was diagnosed with meniere’s disease (almost 30 years ago). From the disease, I have experienced a few instances of SSHL, and have had constant tinnitus for many years. Would you consider taking me as a test subject for one of the trials (assuming FX-322 is still in the trial stages). Thank you!
i heard that they are recruiting people to participate the clinical trial right now, Search the page on Facebook “Auditory Rehabilitation & Clinical Trials Lab”
I would love to see this come to market as I have now had 3 separate instances of unilateral SSHL in the last 13 years resulting in sustained hearing losses. I would hope that I would be a good candidate for the drug.
I am from China, a young man in his 20s. In the years after birth, my drug poisoning caused neurological deafness, which caused me to have a lot of troubles in my life, work, study and communication. I hope the next test list There will be me inside, I am looking forward to it. I am a person who loves life and has a special desire for hearing. I am eager to hear the sound.
Reading this makes me so happy!! I am 48 years old and 2 years ago I lost my hearing…was told I have Sudden Hearing Loss Syndrom. I have a BAHA implant but it is NOT the same as my own hearing. I pray for those that are working on this project. You have given me hope that some day my hearing might be restored. Keep working hard! I will be in a trial if needed. Blessings!
Count me in if you need participants for the study…healthy 55, hearing loss both ears.
Keep up the good work I would like to participate in a new study when one comes available
I would love to be able to participate in the next trials as I have hearing loss on both ears.
God bless you.!! I so hope you succeed. Your work is vitally important to millions of people.
I would be willing to take part in a study. I am a healthy male, 50 years old.
I have had progressively worse hearing loss along with progressively louder tinnitus for 27 years. I’m only 50 years old, but my hearing has so adversely affected my quality of life. And it worries me about my future employment opportunities as well.
I, and members of a HLAA Support Group in RTP, North Caroline, would like to participate in future clinical trials. We have followed your research with high interest.
Excellent. I would like to participate in the next trial of FX-322. Robert Perez
I would like to participate in the next phase of FX-322 study.
I have had sensorineural hearing loss for more than 25 years. I was a musician & it’s taken away my ability to perform due to not being able to hear notes or pitches. I hope this trial is successful so that people like me can enjoy music again. I really miss it. It also makes it difficult with my day job as an educational aid.
would love to participate in fx322 trials
Je suis concerné, perte audition oreille gauche, choc sonore ,dramatique,
Ce serai formidable de pouvoir régénérer les cellules cilliees
I have sadden herring loss both ear apx 11 month after do my left hand fistula I am interested of new sadden herring loss fx 322/23 if work now do kidney transplant my health is feet fully Mohd Shahabuddin Chittagong, Bangladesh
This news is very exciting and positive. I, too, suffer from hearing loss. Perhaps the science will arrive, in time, to effect better hearing for me (and others). Thank you. All the best.
Thank you so much for the information. Keenly waiting for the next phase result. It would be great to see my daughter hear without hearing aids. God bless the team behind this. Hope it reaches India soon.
I have followed your progress since an interview on NPR Science Friday several years ago. I suffer with profound hearing loss. Nearing the decision of a cochlear implant. How I would rather be a participant in your 2a study. I am 73 years old, but in good health. Please consider me as a participant.
My daughter is suffering with moderate to severe sensorineural hearing loss in both the ears. we are interested to participate in the next of phase of clinical trials where ever it is in the world. Please let us know the details if eligible for the study.
I am a Korean hard listener. I want to participate in clinical trials as a subject. If it’s hard to get involved, can I buy a clinical trial drug?
On soufre beaucoup dans la société et vous suivez depuis des années on attend le médicament miracle pour trouvé place perdu dans la société
Je vous félicite et bon courage pour la suite
Je suis intéressé par essaie clinique
Estoy muy contento de saber estos resultados positivos soy de Colombia y espero poder beneficiarme del tratamiento Dios los bendiga.
THANK YOU SO MUCH FOR WORKING ON THIS. THIS IS A FANTASTIC BOON FOR PEOPLE SUCH AS MY MOTHER WHOSE EFFECTIVE, YET HIGHLY EXPENSIVE HEARING AIDS HAVE GONE MISSING MANY TIMES IN NURSING HOMES, AND FOR PEOPLE WHO ARE SIMPLY TOO SELF CONSCIOUS TO WEAR DEVICES STILL ASSOCIATED WITH AGING. FURTHERMORE, HEARING AIDS OFTEN DON’T WORK WELL ON THE PHONE, AND CAN CAUSE ALOT OF FRUSTRATING CONVERSATIONS. I KNOW WELL FROM EXPERIENCE. I’VE BEEN FOLLOWING YOUR RESEARCH FOR OVER A YEAR AND AM SO HAPPY TO HEAR YOU WILL PROGRESS TO THE NEXT STAGE. I IMPLORE YOU TO FAST TRACK THIS TO THE FDA. THANK YOU AGAIN, AND G-D BLESS YOU.
SINCERELY, SHARI, SYOSSET, NEW YORK
Really happy that the initial phase has been positively conducted. I am desperately waiting for the drug to be launched. It would be a blessing for all affected by SNHL.
Great to know this. I have been suffering from SSHL and would be interested if the clinical trial is extended to India and other parts of the globe
I have followed your research for several years and am very interested in your work. I am currently going through chemo for the 4th time and am losing even more hearing. I would be interested in clinical trials if needed.
It would be amazing to have my profound hearing loss improved . Pls keep working hard – would be willing to be in a clinical study – I have very little sound comprehension left – so much I want to enjoy that has been taken away due to loss of hearing. This research is vital to so many who are suffering .
Do keep me up to date please with clinical trials.