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I still cannot understand why people are supporting the slow-paced release and the strategy of Auricle trying to launch the device themselves. Plenty of pharmaceuticals are approved within six months of finishing their Phase 3 trials. Consider the pain medication Suzetrigine (VX-548), which just...

It's not 15 months away, but it's the closest so far. It's the only pill in Phase 3 where we are 100% sure that some people will benefit from it. Some people have achieved silence or near silence using Retigabine. Not a single pill in trials now or on the market available has ever been able to...

It's adjusted one quarter back, unfortunately. Yes, I think this is our only bet in the coming 12-15 months. Calming down hyperexcitability is the key to curing many diseases, epilepsy, pain, Alzheimer's, tinnitus... I do, despite the fact that no one talks about EMA approval in any of their...

From the Q4 investors call this week:

I might visit the symposium, I live 30 minutes away. Thanks for sharing.

I think reactivity is caused by hair cells that are damaged/vulnerable but not yet broken. These hair cells are much more susceptible to noise trauma. Over time they either break down (worsening early on) or stabilize (less reactive/strengthened) but are still easy to break. They are essentially...

That is approval to trial. Not approval to market.

Fits like a glove to Auricle. Trade/Device Name: Lenire Regulation Number: 21 CFR 874.3410 Regulation Name: Combined acoustic and electrical external stimulation device for the relief of tinnitus Regulatory Class: Class II Product Code: QVN From...

It is completely normal to submit almost 2 years after completing your final trial to the FDA for a class II device which has an equivalent substitute? Biggest BS in this thread so far. They had plenty of time to make pre-arrangements. They had plenty of time to fundraise through corporations...

The results are promising but as with 99% of all research, it will likely not be followed up. I don't see why it would bring lasting effects for that long, looking at the half life of these drugs. I don't see anything on inducing neuroplasticity in the article. I'm personally very hesitant with...

→ Saniona’s CEO: ”Selectivity is the cornerstone of future epilepsy treatments” Saniona is next in line to develop a Kv7.2 drug. This one is still far out though. From my understanding, there are now four in trials US/Worldwide, one in China and one starting in the near future.

Second half 2024 could be anywhere between July and December. Trial completion will be at the end of 2024. Best case scenario would be essentially a December 2024/January 2025 data readout, worst case scenario data readout summer 2025. XEN1101 does not have FDA Fast Track. I'm still hoping...

Why? I just estimated Q3-Q4 2024 and that is exactly what second half year means which they are stating. Right on spot. This is very good news! Within a year from now the trial closes. After that there is the actual trial period and readout of the last patients. This means data readout and...

The date on ClinicalTrials.gov is a placeholder and not based on facts. They said there is no known estimated completion date. I'm gambling for Q3-Q4/2024.

Xenon Pharmaceuticals has their Q3 update call on the 8th of November. This call will be important for the timelines of XEN1101.

The abstracts for the 2nd Kv7.2 Channels Symposium are online: 2nd Kv7 Channels Symposium: Programme Seems like Dr. Thanos Tzounopoulos didn't submit any abstract. :(

No, this hearing loss is the same as any other hearing loss. For a clinical trial you need to narrow down a sickness/situation that is the same "incident" for all patients. If you would test noise exposure, all participants have different exposure, different incident and different impact. Here...

Who is hyping what? Where do you see hype from Auricle? We obviously set the bar of expectation way too high. They clearly fundraised at the wrong location and there is apparently no large company as an investor behind this. It points to private equity that provided some funding for the first...

As I said, there is insufficient data and safety information available for compassionate use of tinnitus. They will not accept off-label for compassionate use. Pain and MDD (treatment resistant depression) is the way to go. You'll have to make sure that your doctor emphasizes major depression...

I strongly suggest to use pain as criteria instead of tinnitus (or hyperacusis with pain). Compassionate use is only for the indication being trialed (because they cannot guarantee safety or efficacy for other conditions). Pain is one of the trial conditions. Compassionate use and off-label at...

There are no NaV1.8 blockers on the market at this moment as I am aware. I'm no scientist but the pain/tinnitus comparison is from hyperexcitability of cells. I don't think VX-548 calms down hyperexcitability - it blocks the 'I feel pain' trigger in the brain.

For people with noxacusis, I'd follow the trial of VX-548 of Vertex Pharmaceuticals which might be of interest. It has 5x Phase 3 trials running at the same time for several pain conditions - the goal is essentially to treat all forms acute and chronic/neuropathic pain. The Phase 3 ends early...

Because there is no mention of two people without tinnitus in the paper? This was in the first study. I'm not sure where that question came from. I guess it was referring to the first study.

Here are my findings from the earnings call, I hope this is helpful. Unfortunately no guidance was given during the call yet, although the topic was addressed several times during the call. They will give guidance on the completion date later this year. What came forward in the Q&A was during...

From my understanding, even though speculation, I think the funding / investor is private equity and not big pharma. We need a large company behind this, focused on neuromodulation (such as Abbott Laboratories) to drive this launch. We don't need a start-up driving this launch independently...

Thank you for summarizing @Markku. Nicely formatted too.The only answer that for me was really helpful is the following: I'm hoping that she unintentionally gave away here that there is currently no FDA requirement on the table for additional studies, especially since the crossover part was...

→ 3rd Inner Ear Disorders Therapeutics Summit Participants include Acousia Therapeutics, Akouous, Spiral Therapeutics, Astellas, Ting Therapeutics, Sensorion and AudioCure Pharma. Seems a lot of early stage, pre-clinical companies attending. I will report if some more information or summaries...

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...

I'm actually very sure of this progressing through Phase 3 if no severe adverse events are found. At least 4 companies worked on New Drug Application for upgraded Trobalt. The indications are neuropatic pain, epilepsy, MDD and ALS. Besides that there are a ton of other indications related to...

I think we will know more or less the ending date at the 10th of August Q2 quarterly figures call. The date on the trial page is just a placeholder and has no meaning. I'm expecting earlier than that (Q4 2024) for epilepsy. The Major Depression Disorder Phase 2 trial is currently finishing up...

19 months was including launching the new study as per requirement of the FDA if I'm not mistaken. I'd say it's very likely that they started as De Novo and had to reapply as I said earlier. There are different criteria for 510(K) and De Novo pathways. And Lenire created the De Novo for bimodal...

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CB03-154 in Healthy Participants There are two trials ongoing for CB03 which is an equivalent to Trobalt, modulating Kv7.2/7.3 channels. This space of research seems to have become very crowded and for a reason. Zhimeng...

The program of the symposium is online on their website. As expected, tinnitus is on the menu. Prof. Thanos Tzounopoulos will speak on tinnitus and Kv7.2 channels.

Some findings: - People with more somatic tinnitus modulation movements benefited better, but it's stated that non-somatic tinnitus should also benefit. - 7 people had worsened tinnitus during treatment (related/non-related), too little detail provided on adverse events. Subjects were removed...

Prof. Shaowen Bao will present on the influence of inflammation and TNF-A on tinnitus next week at the TRI 2023. There has been a clinical trial on going for some time for the usage of Etanercept to lower TNF-a blood value and to lower tinnitus. Prof. Shaowen Bao's name does not appear in the...

Good question. It looks like it, but I'm not sure.

@Nick47, a different Kv7.2 modulator currently being trialed in China is Pynegabine HN37. It already completed Phase 1 and is moving to Phase 2. It is based on Retigabine. HN37, trial number: CTR20201676 and CTR20222616. Hope your mandarin is sufficient :) There is a Kv7 symposium this year in...

They expanded the number of candidates and are apparently open for recruitment again. They postponed the completion date to September, unfortunately.

I just want to chip is as a professional dentist customer (visited too often in the last year for several root canals due to an incompetent dentist who overheated/killed three of my teeth in the process). The reason why one drill is extremely loud while others are not is not always related to...

Where am I spreading negativity? I'm stating the facts and basically saying the same thing as you. She will stop teaching and stop researching physically at the lab. Indeed this is very common. She will for sure still be involved in the background as an advisor. I guess she wanted her retirement...

Susan Shore officially retired, as per last week, from the University of Michigan and will have Regent status. (Source: PDF) I guess this implies teaching and research.

You know, I have been dealing with neuropathic pain for some time now in parallel with tinnitus. Neuropathic pain shares a lot of similarities with tinnitus. It is often caused by local nerve damage but, as the pain continues, it gets centralized in the brain. Amitriptyline and Gababentin are...

No, they are shifting away because they are creating a pediatric version of XEN1101. Also, the age group for XEN1101 has been extended in the trial (12 years and older). Hopefully this increases the target group size and accelerates the enrollment of patients.

I cannot comment on potency. All we hear from the companies is that their product is best in class. Everyone claims the same. There are two XEN1101 Phase 3s running. They will likely finish earlier then expected. Xenon Pharmaceuticals will likely comment on an estimated timeline in Q3. There...

XEN496 program has been killed mid Phase 3 and they are shifting the focus to only XEN1101. This was reported in the Q1 financial call of Xenon Pharmaceuticals yesterday.

I'd say so. I wouldn't be surprised if it influenced neuropathic pain too as antiepileptics are known to calm down nerves. Antidepressants and antiepileptics are the drugs of choice for neuropatic pain. I'm no expert in how the pharmaceuticals target the brain but it seems that hyperacusis is a...

I think so. Yesterday I stumbled upon another Kv7.2 trial in Phase 1. I forgot to bookmark it but there are more companies working on this.

ClinicalTrials.gov: Evaluation of Auditory Mirror-Therapy for Tinnitus The primary endpoint of the trial has been reached.

See here the classification again for ear, tongue or skin stimulation together with acoustic stimulation for treatment of tinnitus. They are clearly grouping skin stimulation with tongue stimulation in the same class. FDA: Product Classification - Combined acoustic and electrical external...

What I'm saying is that the De Novo route is a different route then a normal 510k with different requirements, different forms and a different process. FDA does not disclosure current submissions/applications due to competitor sensitivity. I don't think they would inform Auricle on this matter...

I'm afraid that, because Auricle took the De Novo route at FDA, things are unfortunately delayed as the device is no longer De Novo because Neuromod completed the route with Lenire. Auricle will be a Class II device: FDA: Product Classification - Combined acoustic and electrical external...

It took 1.5 years. The submission date was August 2021. It has been categorized as De Novo class II device. One of the risks stated was an increase in tinnitus. Mitigation for this was clinical performance testing and labeling the device/warning. There was also a side effect of hearing loss due...

In last week's investor call, questions were asked on the Phase 3 timeline. Unidentified Analyst: Hi, this is James on for Paul. Thanks for taking our question. Just as it relates to the recruitment challenges, some others are facing in the focal epilepsy space, as you mentioned, you...

BHV-7000 completed its Phase 1 successfully. Preliminary Safety: Single doses up to 100 mg and multiple doses up to 40 mg daily x15 days generally well-tolerated Most adverse events mild and resolved spontaneously No serious or severe adverse events No dose limiting toxicities This means it...

It clears the path for Dr. Shore (Auricle) to have a faster approval because it is not a De Novo technique/device anymore. This is good news in my opinion.

Hi @Markku, my gut feeling is that it is related to the color sensory treatment. But then again, very little information is known. It went through 2 trials apparently. University of Leicester is finalist in new technology challenge Effect of Tinted light on Perception of Tinnitus

Don't forgot the University of Leicester who have been working on a tinnitus device for 8 years already, which very little is known of: https://www.tinnitustalk.com/attachments/innovative-device-tinnitus-pdf.53695/ But I agree, although Dr. Dirk de Ridder seem to have more of a cowboy approach...

Xenon Pharmaceuticals is estimating the trial to last 2 years, just like Phase 2, with an estimated ending of late 2024/early 2025. They stated this during their Q4 call in 2022. They are now expecting more swift patient recruitment because there is no COVID-19 delay and the results of Phase 2...