Date: 2017-07-20
Type of information: Product acquisition
Compound: AM-125 (betahistine dihydrochloride)
Company: Auris Medical (Switzerland) Otifex Therapeutics (Australia)
Therapeutic area: Otorhinolaryngology
Type agreement: product acquisition
Action mechanism:
- Betahistine is a small molecule drug that acts as a partial histamine H1-receptor agonist and a H3-receptor antagonist. The compound has demonstrated increased cochlear, vestibular and cerebral blood flow, vestibular compensation and the ability to inhibit neuronal firing in the vestibular nuclei. Oral betahistine is approved for the treatment of Meniere's disease and vestibular vertigo and marketed in more than 80 countries worldwide. Since its launch, more than 130 million patients have been prescribed betahistine. However, betahistine has not been approved for marketing in the United States for the past few decades.
Disease: Meniere's disease and other vestibular disorders
Details:
- • On July 20, 2017, Auris Medical announced that it has completed its acquisition of various assets related to intranasal betahistine from Otifex Therapeutics. The assets, which comprise preclinical and clinical data as well as intellectual property rights, have been fully transferred to Auris Medical with the closing of the transaction. They form the basis for the development of AM-125, an intranasal formulation of betahistine for the treatment of Meniere's disease and other vestibular disorders. In addition to the Otifex transaction, Auris Medical obtained from an undisclosed party the right to use certain proprietary preclinical and clinical data that will support the AM-125 development program and future regulatory filings.
- Auris Medical plans to initiate the second Phase 1 trial of AM-125 in the fourth quarter of this year. In a previous Phase 1 trial, intranasal betahistine demonstrated good tolerance and significantly higher blood plasma concentrations when compared to data reported with oral betahistine. In addition, a 14-day study in beagle dogs demonstrated that intranasal delivery was well tolerated with repeated dosing. The second Phase 1 clinical trial of AM-125 is planned to evaluate single- and multiple-ascending doses in healthy subjects. The study will determine the maximum tolerated dose following intranasal administration and assess pharmacokinetics in blood plasma. The study outcomes will inform dose selection and regimen for a subsequent Phase 2 proof-of-concept trial.
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