Frequency Therapeutics Archives - Medical Design Sourcing

Frequency Therapeutics shares plummet after FX-322 Phase 2b failure

Frequency Therapeutics (Nasdaq:FREQ) shares were down more than 80% on Monday afternoon after the company announced the failure of the Phase 2b study for FX-322, its lead candidate drug for hearing loss. As a result, the Lexington, Massachusetts-based biotech company will discontinue its hearing loss program and cut its workforce by 55%.

It says its cost savings measures will extend its runway into 2025.

In late 2022, Otonomy, another neurotology biopharma once listed on Nasdaq, said it had decided to dissolve its business and liquidate its assets.

FX-322 had no statistically significant difference over placebo

Frequency Therapeutics said the Phase 2b study showed that the drug FX-322 did not improve speech perception more than placebo. The company will also discontinue its second program for sudden or noise-induced sensorineural hearing loss, FX-345.

FX-322 did not meet its primary endpoint or any of the study’s secondary endpoints. The saf…

Decibel Therapeutics announces study on noise-related inner ear damage

Decibel Therapeutics (NSDQ:DBTX) has a working hypothesis that molecular characterization of the cell biology of the inner ear could pave the way for treatments for hearing and balance disorders.

The Boston-based biotech company has announced that a recent study published in Cell Reports supports that hypothesis.

“We were thrilled to leverage our data and expertise in inner ear biology to help fuel this analysis, which may help enable identification of therapeutics that counter the observed trends in gene expression that occur following noise exposure,” said Joe Burns, vice president, discovery at Decibel Therapeutics, in a statement.

The company partnered with the University of Maryland School of Medicine and the Karolinska Institute on the research.

Decibel Therapeutics had its IPO on February 12. Its shares have since fallen from $18.03 apiece to $7.71 today.

Lexington, Massachusetts–based Frequency Therapeutics has also seen its stoc…

Frequency Therapeutics faces growing legal challenges

Hearing loss drug developer Frequency Therapeutics (NASDAQ: FREQ) is the subject of a growing number of security fraud accusations on behalf of investors.

Earlier this year, things were looking up for the company’s lead product candidate, FX-322. But on March 23, Frequency Therapeutics announced that interim results suggested that FX-322 was not effective at improving mild to moderately severe sensorineural hearing loss in a Phase 2a study compared to placebo. Previous results from a smaller study had been more positive.

The company’s stock fell from a high of $55.01 on Feb. 19 to $9.55 in mid-day trading on June 15.

Among the law firms filing lawsuits against Frequency Therapeutics is Robbins LLP (San Diego), which recently filed a class-action lawsuit for purchasers of Frequency Therapeutics stock between Nov. 16, 2020 and March 22. That lawsuit alleges that the company misrepresented its FX-322 experimental drug in earnings calls, press releases, SEC …

Otonomy expands Phase 1/2 hearing loss clinical trial

Neurotology drug developer Otonomy (NSDQ:OTIC) is expanding a Phase 1/2 trial of OTO-413 in patients who have difficulty with speech-in-noise tests. In the trial, clinical investigators administer the drug as a single intratympanic injection.

The company said that OTO-413 showed promise in improving hearing in a dose escalation efficacy cohort.

The randomized, double-blind, placebo-controlled Phase 1/2 study will be relatively small, involving approximately 30 hearing loss patients. A total of 20 people will receive OTO-413 with the remainder receiving placebo.

“We are pleased to initiate this expansion study in order to demonstrate the treatment benefit in a larger cohort of hearing loss patients, continue our evaluation of multiple speech-in-noise hearing tests, and provide important information to help us design and power a more formal Phase 2 clinical trial,” said David A. Weber, president and CEO of Otonomy, in a statement.

OTO-413 is a formu…

DTW Podcast: McEvoy gives edge to J&J’s second-mover strategy in digital surgery

Johnson & Johnson may have left the gate than some digital surgery competitors but Ashley McEvoy, executive vice president, worldwide chairman, medical devices, says the company has the technology and the team to win the race.

In an interview with DeviceTalks Weekly Podcast, McEvoy said robotic and digital surgery systems currently on the market have only been adopted by a small percentage of providers, leaving the field open for new competitors like J&J.

“Surgery is a slow adoption business,” McEvoy said,

While offering “huge respect” for the first movers. McEvoy said J&J enjoys market leadership right now in surgery. Its size and reach will open doors for its three digital surgery systems – Velys, Monarch and Ottava.

“We’re going to have a differentiated value proposition doing so in a broad-based healthcare, J&J fashion, not just like a standalone med tech company,” she said.

McEvoy pointed to the team J&J as as…

J&J leader McEvoy lays out future for medtech giant; Stryker’s Murray talks 3Dprinting

J&J’s Ashley McEvoy talks COVID-19, Digital Surgery, Innovation and the future of Vision Care.

In this week’s DeviceTalks Weekly Podcast, the 50th of the series, Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices, Johnson & Johnson, makes her DeviceTalks Weekly debut.

In this update, McEvoy delivers great insights on several areas of interest including:

COVID-19’s impact on J&J in the past, and what changes may remain in the future. J&J’s far-ranging digital surgery portfolio could bolster many of its specialties. How the company uses its innovation network to accelerate development Why she’s bullish on the future of eye care. How the company will prepare for future challenges.

We also talk with Naomi Murray, Director of Advanced Operations-Additive Technology at Stryker about her almost predestined path to join the orthopedics leader.

She’ll be leading the March 23 discuss…

Frequency Therapeutics drug shows promise in restoring hearing in small study

Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug.

The small Phase 1/2 study, which was published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss.

At present, there are no FDA-approved drugs for preventing or restoring such hearing loss, although administering steroids can facilitate recovery of hearing for some patients with sudden sensorineural hearing loss.

The Frequency Therapeutics study found that participants who received a single dose FX-322 had a statistically significant increase in word recognition.

Get the full story from our sister site, Drug Discovery & Development.

Frequency Therapeutics drug shows promise in restoring hearing in small study

Frequency Therapeutics (Woburn, Mass.) recently announced data related to its experimental FX-322 drug.

The small Phase 1/2 study, which was published in Otology & Neurotology, found hearing improvements in adults with age-related sensorineural hearing loss.

At present, there are no FDA-approved drugs for preventing or restoring such hearing loss, although administering steroids can facilitate recovery of hearing for some patients with sudden sensorineural hearing loss.

The Frequency Therapeutics study found that participants who received a single dose FX-322 had a statistically significant increase in word recognition. The drug was administered as an intratympanic injection — that is, into the middle ear space. Placebo recipients did not demonstrate meaningful improvement.

Researchers have demonstrated that FX-322 has led to a regeneration of mammalian cochlear hair cells in ex vivo experiments.

Frequency Therapeutics is now evaluating…