What is SENS-111?
First-in-class, histamine H4 receptor antagonist selected to treat acute unilateral vestibulopathy:
- Administered orally
- No sedative effect
Works by having a pronounced inhibitory effect on vestibular neuron activity, thus, reducing vestibular tone imbalance.
Should alleviate vertigo symptoms without the common sedative effects of current off-label vertigo treatments.
Extract from KOL event2016, Nov 29th Presented by Prof M. Strupp
Preclinical and Clinical Data
Data from several preclinical and clinical studies are available.
- Pharmacokinetics, pharmacodynamics, safety and tolerance evaluated in several preclinical studies and multiple phase 1 trials
- Good inner ear exposure after systemic administration in preclinical studies
A multicenter, randomized, double-blind, placebo-controlled phase 2 study has been conducted to assess the efficacy and safety of 2 oral doses (100 mg and 200 mg) for 4 days in patients with acute unilateral vestibulopathy. [Clinicaltrials.gov].
See the press release.
SENS-111 was safe and well tolerated. However, it did not meet the primary endpoint of vertigo intensity, measured by the area under the curve of the vertigo intensity visual analogue scale (VI-VAS) in standing position over the four treatment days, with eight post baseline assessments
About Acute Unilateral Vestibulopathy (AUV)
AUV (also called vestibular neuritis) is a cause of severe acute vertigo.
AUV is a rare or orphan disease (annual incidence of 3.5 to 15.5 per 100,000 persons), with the usual age of onset between 30 and 60 years.
Although no commonly accepted cause has been established, potential causes include viral, vascular, autoimmune or infectious origins.
Key symptoms are:
- Acute onset of sustained rotatory vertigo
- Apparent movement of visual surroundings (external vertigo) and pathologic deviation of the subjective visual vertical
- Postural imbalance with a tendency to fall toward the affected side
- Nausea and vomiting
- Horizontal, torsional nystagmus beating towards the non-affected side
These so-called "big-five" symptoms allow a differentation between peripheral or central vestibular lesions.
- Strupp M, Magnusson M (2015). Acute Unilateral Vestibulopathy. Neurol Clin 33:669-685. Pubmed
- Desmadryl et al., (2012) Histamine H4 receptor antagonists as potent modulators of mammalian vestibular primary neuron excitability. Br J Pharmacol, 167(4):905-916. Pubmed
- Wersinger et al., (2013) Symptomatic treatment of vestibular deficits: therapeutic potential of histamine H4 receptors. J Vestib Res 23(3):153-159. Pubmed
- Attali et al., (2016) The Effects of SENS-111, A New H4R Antagonist, On Vertigo Induced by Caloric Test in Healthy Volunteers (HV) is Related to Plasma Concentrations. Clin Ther. 38(10S):e4. doi: 10.1016/j.clinthera.2016.07.024. Pubmed