Date: 2015-06-25
Type of information: Clinical research agreement
Compound: AM-111
Company: Auris Medical (Switzerland)
Therapeutic area: Otorhinolaryngology
Type agreement: clinical research
Action mechanism: peptide. AM-111 contains the synthetic peptide D-JNKI-1 (D-stereoisomer of c-Jun N-terminal Kinase Inhibitor 1), an inhibitor of the JNK stress kinase coupled to an intracellular transporter. D-JNKI-1 is formulated in a biocompatible and fully biodegradable gel. It is administered by a single dose intratympanic injection into the middle ear. From there the drug diffuses through the round window membrane into the cochlea. JNK is a signal transmitting enzyme that regulates a number of important cellular activities, including activation of genes encoding inflammatory molecules or promoting cell death (apoptosis). JNK is activated following various types of cochlear insults (stress) that may lead to acute inner ear hearing loss. AM-111 enters cells and binds to JNK, thereby inhibiting activation of transcription factors such as c-jun and c-fos. This in turn prevents JNK mediated apoptosis and inflammatory response, which could otherwise result in irreversible loss of hair cells and cochlear neurons. AM-111 supports natural recovery processes and helps to prevent or reduce chronic hearing loss.
Disease: patients with residual hearing who are undergoing cochlear implant surgery
Details: * On June 25, 2015, Auris Medical and Cochlear, a global leader in implantable hearing solutions, announced they will collaborate on a planned randomized placebo-controlled clinical trial in the United States (the REACH trial). REACH shall evaluate Auris Medical's cell penetrating otoprotectant AM-111 in patients with residual hearing who are undergoing cochlear implant (CI) surgery. Under the collaboration, Cochlear will support preparations for REACH and provide expertise in cochlear implants and hearing preservation. Drug-based otoprotection during cochlear implantation has attracted growing interest in recent years. Under the concept of Electro-Acoustic Stimulation, also known as "Hybrid Hearing", electrical stimulation is delivered through a cochlear implant alongside acoustic stimulation provided via hearing aid functionality built into the cochlear implant sound processor. The hearing aid functionality acoustically amplifies low frequencies while the cochlear implant electrically stimulates middle and high frequencies. Hybrid Hearing assists patients with severe to profound high-frequency hearing loss and some degree of low frequency residual hearing, who would otherwise receive only limited benefits from a traditional hearing aid alone and may suffer from inadequate speech understanding, especially under noisy conditions. It is expected that more effective otoprotection during cochlear implant surgery (in particular during cochlear electrode insertion) will support further adoption of Hybrid Hearing. In a pre-clinical model of cochlear implant surgery trauma, local application of AM-111 30 minutes prior to electrode insertion provided significant protection against surgery-induced hearing loss, loss of hair cells and damage to neural elements. Auris Medical plans to seek grant funding in support of the REACH trial and expects enrollment to start in the third quarter of 2016.
Financial terms:
Latest news:
