Frequency Therapeutics — Hearing Loss Regeneration

It's all phases.

 

I'm saying that based on what HEI has said about their pills helping with tinnitus as opposed to Frequency who has said nothing on it so far.

Based on Dr. Dr. Shore's first trial results and her saying that she is seeing the benefits are cumulative from this second one, I'm willing to bet my livelihood that her device will help a great percentage of us. You saw her in the video interview from the TRI right? She said with absolute confidence she can see treatment coming in the next decade. I'm certain she had her own device in mind.

 

Nitpicking mode on: I think it happens at the same time. Supporting cell divides into supporting cell and hair cell. Could be wrong.

 

It's like this:

 

Thank you.

 

Yes, division/mitosis leads to both a new supporting cell (inactive progenitor cell) and hair cell (functional target cell) at the same time. By the way, this picture leaves out that with mitosis sometimes both new cells are supporting cells or hair cells, instead of one of each.

 

Interesting. Do you have a source for that?

 

If this is true FX-322 needs to make a QUICK pivot to including growth factors in their solution to encourage differentiation into the hair cell. This is what worries me.

 

I can believe that. How could they even ensure 1 of each every time?

 

The only thing that should worry you at this point is the ability of this drug to cross the round window membrane in significant quantities.

 

Who will be the first Tinnitus Talk member to be accepted into the FX-322 trial and try this out?

 

Frequency Therapeutics Provides Business Updates and Reports Third Quarter 2019 Financial Results
Initiated FX-322 Phase 2a clinical study for sensorineural hearing loss

Granted FDA Fast Track designation for FX-322

Completed an $88.6 million initial public offering in October 2019, providing Company runway into 2022

November 18, 2019 07:30 AM Eastern Standard Time
WOBURN, Mass.--(BUSINESS WIRE)--Frequency Therapeutics, Inc. (Nasdaq: FREQ), a clinical-stage biotechnology company focused on harnessing the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases, today announced business updates and financial results for the third quarter ending September 30, 2019.

“This has been a tremendously productive period for Frequency as we commenced our Phase 2a study, received Fast Track designation for FX-322, and completed key financings that we believe will enable us to advance our hearing program and further diversify our portfolio as we apply our progenitor cell activation platform in numerous disease areas,” said Frequency Therapeutics Chief Executive Officer David Lucchino. “We have opened all U.S. sites for our Phase 2a study of FX-322 and remain on track to report top-line data in the second half of next year. We believe FX-322 has the potential to be a restorative, disease-modifying treatment for the millions of patients with hearing loss, with the aim of improving hearing function, including speech intelligibility. We also continue to advance our multiple sclerosis development efforts and remain focused on moving our remyelination program into the clinic in the second half of 2021.”

Recent Business Highlights

• Initiation of FX-322 Phase 2a Study for Sensorineural Hearing Loss (October 2019): The Phase 2a clinical trial is a multi-center, randomized, double-blind, placebo-controlled, single- and repeat-dose study of FX-322, expected to enroll approximately 96 adults aged 18 to 65 with stable sensorineural hearing loss at 12 sites in the U.S. Patients will be randomized to one of four groups, each of which will receive four injections, once per week, at weekly intervals starting at the initial visit. The key efficacy endpoints of this trial are word recognition (WR), words-in-noise (WIN), and standard pure tone audiometry. Exploratory efficacy endpoints are extended high frequency pure tone audiometry, the Tinnitus Functional Index (TFI), and the Hearing Handicap Inventory in Adults (HHIA).
• FX-322 Fast Track Designation (October 2019): The United States Food and Drug Administration (FDA) granted Fast Track designation for FX-322. This designation is intended to facilitate development of new therapies for serious conditions with unmet medical need, expedite review, and enable more frequent engagement between the Company and the FDA regarding study planning and design.
• Completion of Initial Public Offering (October 2019): Frequency completed an initial public offering of 6,325,000 shares of common stock, which included the partial exercise of the underwriters’ over-allotment option for 325,000 shares, at the offering price of $14.00 per share for total gross proceeds of approximately $88.6 million, before deducting underwriting discounts and commissions and other offering expenses. Frequency common stock began trading on the Nasdaq Global Select Market on October 3, 2019 under the ticker symbol “FREQ.” J.P. Morgan, Goldman Sachs and Cowen were joint book-running managers for the offering.
• Presentation of FX-322 Phase 1/2 Data (September 2019): At the American Academy of Otolyrangology – Head and Neck Surgery annual meeting, Frequency presented data from the Phase 1/2 study of FX-322 in which a statistically significant and clinically meaningful improvement in key measures of hearing loss, including clarity of sound and word understanding, was observed. In addition, FX-322 was observed to be well-tolerated with no serious adverse effects. The Company also presented preclinical and clinical data from the Phase 1/2 study at the 2nd Annual International Symposium on Inner Ear Therapeutics (ISIET) in Hanover, Germany in November.
• Strengthened Leadership Team (August 2019): Frequency expanded its leadership team with the addition of Dana Hilt, M.D., as Chief Medical Officer, William Chin, M.D. as head of Clinical and Translational Science; Jason Glashow as head of Corporate Affairs; Jeff Hrkach, Ph.D., as head of Technology Development; and Michael Bookman as Deputy General Counsel.
• Completion of Crossover Financing (July 2019): The Company completed a $62 million private financing led by Perceptive Advisors and a syndicate that included Deerfield Management, RTW Investments, and Mizuho Securities Principal Investment.
• License and Collaboration Agreement with Astellas (July 2019): Frequency entered into a license and collaboration agreement with Astellas Pharma, Inc. (Astellas) for FX-322. Frequency received an $80 million upfront payment with the potential of up to $545 million in future milestone payments as well as double-digit royalties. Astellas obtained the exclusive rights to develop and commercialize FX-322 in ex-U.S. markets; Frequency retains U.S. rights

https://www.businesswire.com/news/h...peutics-Business-Updates-Reports-Quarter-2019

 

Well, I'm right around the corner of Woburn. I dunno if I'll qualify though. As has been stated, they are primarily screening for hearing loss, not tinnitus. With only 96 slots they're gonna be picky.

 

Ring them and ask. I think an earlier post stated that you must state to them a certain event that caused your hearing loss.

 

No testing in the north east brother, as I recall North Carolina may be the closest to you... go to ClinicalTrials.Gov and search FX-322, it will give you locations and a 800 number. Shame they didn’t do something in and around Bean Town... another mystery.

 

Just my luck.

 

Can’t believe it’s a 50/50 shot with no access provided to placebo post-trial. Unethical.

 

Unethically stingy.

 

I think you have a 75% chance of getting at least some drug in this trial. I believe it's like this:

25% all placebo
25% one placebo, 3 drug
25% half and half
25% one drug, 3 placebo

 

Four times the drug is also in there. If I’m correct one placebo, 3 drug is not an option.

 

What is this “disease-modifying” ridiculousness they keep talking about ever since Phase 1/2? That doctor speak for “we can’t do shit about a big part of the problem”? What happened to “if you can’t solve the underlying malady, you won’t able to command a premium” - Lucchino? I can see the ads already: “FX-322, making your hearing aids sounding better than ever. Maybe.”

 

New presentation on where they are and results of Phase 1/2. From 14:30 it gets particularly interesting.

https://edge.media-server.com/mmc/p/nfxzf922

 

In real world, laymen terms, what does this mean?

 

It’s not a 50/50 shot. You have a 75% chance of getting at least one round of the drug.

 

Yeah, you are correct. I tried to do it from memory from when i went to apply but I just watched the linked presentation above and it's dosed like you have it written.

 

Four times the amount per dose compared to the last trial?

 

I get you, but I think it might just mean that it (curatively) affects the underlying disease instead of just treating symptoms.
See https://www.ncbi.nlm.nih.gov/m/pubmed/19751920/ “...Disease modification can be defined as treatments or interventions that affect the underlying pathophysiology of the disease and have a beneficial outcome on the course of [the disease]”
(found by googling “disease-modifying”).

 

A few things stuck out:

1) They are seeking to label FX-322 for *all* causes of SNHL. Not just NIHL or just sudden hearing loss either.

My guess is that this means they hope to broaden their future phase 3 study to include age-related and/or ototoxic patients. I think it's very possible they will include tinnitus patients with relatively normal audiograms here, too, under this label if they get good results in phase 2b.

2) Based on the trial design, there is no way the patients just improved because the words in noise test was easier the second time as was suggested here on this thread a while ago. They tested treated and untreated ears on the same person. Only the treated ears had word score improvements.

 

FX-322 is given great importance but it is something intended for hearing loss and nothing indicates that it works for tinnitus. This is a forum for tinnitus patients, not for hearing loss patients.

 

They are measuring THI (Tinnitus Handicap Inventory) during this trial phase.