Sensorion's New Drug: SENS-401

Sensorion Update on SENS-401

Update from 17 March 2022.

To be honest I am really confused why they failed with drug when there was a minimum of 10 dB improvement in 28 days as well as other bigger improvements in sub-groups.

Can someone explain me please, isn't a 10 dB improvement a lot when you realize it takes 28 days to happen?

 

Without knowing a lot about this drug, I believe that a 10 dB change doesn't mean anything much, since it may be due to testing errors. There is a whole range of subjective stuff that can happen within 10 dB. I personally have audiograms that show that one time I lost 10 dB at some frequency and in some months' time, a new audiogram shows that I gained them back or stuff like that.

 

There are 20-30 dB improvements, I don't think you can get such in 3 months by coincidence.

 

For information, two new studies of SENS-401 are to follow in France and Australia. Results in 2023.

Evaluation of the Presence of SENS-401 in the Perilymph

 

Another good find.

 

Sensorion Reports Positive Efficacy Data from SENS-401 Phase 2a Clinical Study

• Positive preliminary data showed SENS-401 has a clinically significant effect on the preservation of residual hearing after cochlear implantation in all adult patients treated so far
• On the 19th of June, Sensorion announced that the patients treated with SENS-401 showed presence of SENS-401 in perilymph. Analysis suggests preservation of 21 dB of their residual hearing compared to the control group six weeks after cochlear implantation at 500 Hz
• Data to be detailed at a webinar today Wednesday, July 5, 2023, led by Professor Yann Nguyen M.D., Ph.D and Sensorion’s management team

MONTPELLIER, France, July 05, 2023--(BUSINESS WIRE)--Regulatory News:

Sensorion (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today reports further analysis from its Proof of Concept (POC) Phase 2a clinical trial of SENS-401 for residual hearing preservation in adult patients following cochlear implantation. Analysis of the preliminary data will be presented at the Company’s KOL webinar taking place today, Wednesday, July 5, 2023 (event details below).

On June 19th, 2023, Sensorion announced that in preliminary data from the Phase 2a study, SENS-401 was detected in the perilymph of all 5 adult patients treated with the product. Levels of SENS-401 were considered consistent with potential therapeutic effects after seven days of repeated oral treatment.

The data unveiled today shows that the study also assessed a number of secondary endpoints, including the change of hearing threshold from baseline to the end of the treatment period in the implanted ear at several frequencies. Study entry criteria required patients to have a pure tone audiometry (PTA) threshold of 80 dB or better (i.e., ≤80 dB) at 500 Hz, defined as indicating a minimal level of residual hearing. Further analysis suggests SENS-401 treated patients demonstrated the preservation of 21 dB of their residual hearing compared to the control group six weeks after cochlear implantation at 500 Hz.

In the SENS-401-treated group (N=5), the loss of residual hearing was only 12 dB, contrasting with a larger loss of 33 dB observed in the control group of four participants not treated with SENS-401. This resulted in a difference of clinical significance of 21 dB between the two groups, suggesting SENS-401 provided a protective effect on early residual hearing loss after cochlear implantation. These original and promising findings reinforce the hypothesis that SENS-401, by crossing the labyrinthine barrier to reach the cochlear compartment, has a positive effect on the preservation of residual hearing.

The Phase 2a trial is a multicentric, randomized, controlled open-label trial aimed at evaluating the presence of SENS-401 in the cochlea (perilymph) after 7 days of twice-daily oral administration in adult patients prior to cochlear implantation due to moderately severe to profound hearing impairment. Patients start treatment with SENS-401 7 days before implantation and continue to receive SENS-401 for a further 42 days.

Nawal Ouzren, Chief Executive Officer of Sensorion, stated: "We are very excited to see such promising new preliminary data for our ongoing Phase 2a clinical study of SENS-401. This is great news for our program and supports our confidence in the potential of our innovative therapy to prevent residual hearing loss in adult patients suffering from moderately severe to profound hearing disorders. This level of residual hearing preservation means patients have a better chance of understanding speech against background noise and perceiving more natural sound quality with speech and sounds."

Géraldine Honnet, M.D., Sensorion’s Chief Medical Officer, added: "Two weeks ago we demonstrated that SENS-401 crossed the labyrinthine barrier to the cochlea. Today, following further analysis, we have gone much further and have shown SENS-401 potential to preserve early residual hearing six weeks after cochlear implantation. Patients treated with SENS-401 showed improved hearing preservation compared to the patients in the control group, corroborating the otoprotective potential of the molecule. We believe SENS-401 is a ground-breaking therapy with great potential in an area of significant unmet need and we are looking forward to seeing the final results of the study."

 

@InNeedOfHelp, this is what we need. By preserving more residual hearing, technological implants are indicated in more and more patients. Hands down technology has the shortest timeframe to improve hearing as regenerative approaches are so far away.

Only issue I've got is it was a very small group to draw significance from. Will it translate to 100 participants?

 

10 dB is a lot. 3 dB is the doubling of air pressure/sound.

 

For the record, the composition of SENS-401 is:

• R-azasetron besylate (a Serotone® enantiomer marketed for chemotherapy-induced nausea and vomiting)
• A 5-HT3 receptor antagonist (setron family) and calcineurin inhibitor. Small molecule administered orally or by injection

Memantine is also an 5-HT3 receptor antagonist, although a 90-day trial of up to 20 mg Memantine yielded no positive Tinnitus Handicap Inventory (THI) changes.

 

What people "perceive" to be half as loud is a 6 to 10 dB reduction.

 

Phase 2 results are due in the first half of this year. 27 participants with the last one recruited a week or so ago.

This would open up more candidates for implant if it were effective.

It has orphan status.

 

They only reported on the presence of drug, not hearing changes vs. control at this stage:

→ Sensorion Announces it Has Met Primary Endpoint for SENS-401 Phase 2a Clinical Study for Residual Hearing Preservation

 

Thank you. That's very clear and helpful information.

 

Positive Phase 2a results, with clinically meaningful hearing preservation at 250, 500 & 750 Hz compared to controls.

→ Sensorion Announces Positive Results from Phase 2a Clinical Trial of SENS-401 in Cochlear Implantation

 

→ Efficacy and safety of SENS-401 in sudden sensorineural hearing loss: The AUDIBLE-S randomized placebo-controlled phase IIb trial

 

I have read through the study. There seems to be a positive spin on this, with the results emitted from the write-up, meaning I can't scrutinize.

What was the primary endpoint?