AudioCure Pharma develops novel pharmaceutical therapies for the prevention and treatment of a range of hearing impairments with high, unmet medical need. Our lead candidate is a novel molecule named AC102. Phase 2 clinical trial has been ongoing for ~1 year. A Study to Evaluate the Efficacy, Safety and Tolerability of a Single Injection of AC102 into the Middle Ear Compared to Oral Steroid Treatment in Patients with Sudden Hearing Loss The drug has EMA orphan drug designation and can move faster through the approval process because of that. The clinical trial pipeline is very much packed at the moment The primary focus of AudioCure’s development program for AC102 is acute hearing loss and acute tinnitus. Currently there are no approved drug treatments available for these disorders. Our front-runner molecule has undergone comprehensive preclinical research which demonstrates that it acts upon the sensory cells and neurons with their connections that are central to the hearing process. As no other drug has shown any such action, AC102 has the potential to become the first breakthrough causative therapy (i.e. treatment aimed at eliminating the cause) for acute hearing loss and acute tinnitus. By treating these conditions as soon as possible after onset, it is our vision to prevent the development of long-term, chronic hearing impairments. Outer hair cells act as amplifiers in the hearing process. Damage by an acoustic trauma can lead to their programmed cell death, a process known as apoptosis. Once dead, these cells cannot be replaced and their amplification role is lost. Our studies demonstrate that AC102 significantly reduces apoptosis of outer hair cells following acute hearing loss. AC102 enhances protection and repair processes Following acute hearing loss, the inner hair cells can also lose their synaptic connection to the auditory nerve. In the presence of AC102 these connections may be restored in an acoustic trauma preclinical model. This suggests that AC102 enhances factors that are central to important protection and repair processes, giving the cells and synaptic connections of the auditory system a greater chance of survival after injury. In summary, AC102 acts as an antagonist of the multitude of pathological processes leading to hearing loss.
Would be great if it had potential beyond the acute phase where likely 99.9% of tinnitus sufferers are.
The fact that they are targetting acute tinnitus and hearing loss is simply stupid---or they want to bring a scam product. As everyone knows, the ear can sometimes repair itself from a recent insult, so how are they supposed to distinguish what the drug really did in the acute period? I call BS on this one.
Recruitment of Sudden Hearing Loss Patients for Clinical Trial: Novel Compound AC102 Outperforms Corticosteroids Preclinically AudioCure Pharma Awarded for Therapeutic Small Molecule for Hearing Loss Personally for me it has to be this part: More and more research suggests hair cells aren't the first thing to go when the cochlea experiences trauma but synapse loss between hair cells and spiral ganglion neurons. Good luck with the trials, it seems they are recruiting in Europe! Excellent news to start off 2024.
I agree. Rinri Therapeutics are taking the auditory nerve approach as are Hough Ear Institute. There are recent findings on auditory nerve damage leading to tinnitus.
The trials are limited to those with SSNHL that occurred less than 120 hours ago. I still don't know how this compound works. Phase 2 is trying to determine if it works better than corticosteroids in humans. We do see more evidence that those with tinnitus may have had some type of dysfunction / trauma to the cochlea even without known acoustic events, any drugs that are shown to be protective of the cochlea might be of benefit to our community. Their models suggest it has outperformed corticosteroids but let's wait to see what the trials say. Corticosteroids' action in the cochlea is complex and I'd suggest reading papers on theories why we use them in the first place. One theory (as literature suggests) is Dexamethasone reduces macrophage polarization from M1 and is a potent M2 polarizer. This means less inflammation (immune system destroying cells) and more macrophages that try to heal (m2). This field is really complicated as it's not as simple as what I paraphrased. This evening I will try and see if there's any more literature on the compound AC102 being trialed as I'd like to know more.
I so badly want to believe in this, but every time I get my hopes up, it always fails. What they say in the press release sure does sound promising. Here's to hoping this one works!
Me too. Phase 2 will prove if their models translate to humans. However, after reading some the literature I'm skeptical as AC102 seems to just be Prednisolone delivered through intratympanic injection (source). And other clinical trials using Dexamethasone (a stronger drug) such as NCT00097448 or NCT00335920 showed only some improvement in hearing thresholds. So this becomes a matter of delivery and perhaps the gel formation they've got is longer lasting than in the previous clinical trials which we know is a big problem with intratympanic injections where the drug just drains away (in some studies it's gone in less than 25 minutes.) Interestingly SPT-2101, Spiral Therapeutics' drug, which contains Dexamethasone, uses a longer lasting gel and both this and SPT-2101 are in clinical trials at the moment.
No, I think you are reading it wrong. In that study the efficacy of AC102 gel is compared to that of Prednisolone. According to this paper, "whilst the composition of AC102 and its precise mechanism of action has not been disclosed, patents filed by the company indicate that it is likely to be a 9-methyl-ß-carboline which has been found to have stimulative, protective, regenerative and anti-inflammatory effects on dopaminergic neurons." According to one of the ARO 2024 abstracts, AC102 is a pyridoindole.
