Frequency Therapeutics Inc. (NASDAQ: FREQ) stock gained by 5.96% at the end of last trading session while the FREQ stock is currently down by 72.44%. Today, Frequency Therapeutics has announced its new data from Two FX-322 clinical studies, planning to modify the single-dose regimen. FREQ is highly known company for the development of drugs which could activate progenitor cells in the body for the treatment of degenerative diseases.
Frequency Therapeutics released its topline, day-90 data of its FX-322 Phase 2a trial (FX-322-202). The initial findings indicate that four weekly injections in patients with moderate to relatively serious sensorineural hearing loss (SNHL) did not boost hearing measures as compared to placebo. Comparatively, Frequency Therapeuticsalso reported new results from a separate study that found that a single injection of FX-322 enhanced hearing. FX-322 will be developed further as a single injection treatment, according to the company.
Findings of the phase 2a study
FX-322 is designed in a way that it regenerates auditory sensory hair cells in cochlea of the patients suffering from SNHL and improve hearing. For the study, total 95 patients aged 18-65 were called for the experiment. They were tested for hearing enhancement using Word Recognition (WR), Words-In-Noise (WIN), pure tone audiometry, and other exploratory steps in the four-arm Phase 2a sample. All the participants received four weekly intratympanic injections, each of which contained nil, one, two, or four doses of FX-322, with the other injections containing placebo doses.
In all groups WR Score increased showing that the four time use of injection is causing no benefit to the patient compared to the participants in which single dose was being used. The Phase 2a preliminary results also revealed an unusual degree of obvious hearing gain in the placebo unit, which had not been seen in previous trials and surpassed the expectations, possibly due to flaws in trial design. Therefore no noticeable hearing gain of FX-322 was observed as compared placebo due to the difficulties identified in the Phase 2a study design.
After this study, that the problem is not with FX-322 but rather they need to improvise their trial design. Repeated use of injections is causing no benefit rather single dose would work better.