MIN-101 (Minerva Neurosciences/Mitsubishi Tanabe) is a novel antagonist of the sigma-2 and serotonin 5-HT2A receptors. It has the potential to modulate dopamine pathways without eliciting the dopamine-related adverse events evident with other antipsychotics as it does not directly bind postsynaptic dopamine receptors.
MIN-101 is being developed to target negative symptoms associated with schizophrenia. Thus far, the novel drug has demonstrated a favorable tolerability profile which is comparable to placebo in Phase II clinical trials. In this way, the pipeline drug may be positioned to address an unmet need, which would importantly allow it to carve out a niche in the schizophrenia market. However, Minerva Neurosciences would do well to trial MIN-101 for efficacy in positive symptoms, as all schizophrenia patients present with these, whereas negative symptoms are predominantly displayed in a subpopulation. Given that all patients with negative symptoms will also have positive symptoms. The author deems it vital for Minerva Neurosciences to expand its development program to ensure MIN-101 can better compete with rival Vraylar (cariprazine; Gedeon Richer/Allergan/Recordati). Vraylar has proven efficacy for both symptom domains, and will likely be approved for negative symptoms before MIN-101.
List of Figures
Figure 1: MIN-101 for schizophrenia - SWOT analysis
Figure 2: Drug assessment summary of MIN-101 for schizophrenia
Figure 3: Drug assessment summary of MIN-101 for schizophrenia
Figure 4: MIN-101 sales for schizophrenia in the US, 2017-26
List of Tables
Table 1: MIN-101 drug profile
Table 2: MIN-101 planned Phase III trial in schizophrenia
Table 3: MIN-101 Phase IIb trial data in schizophrenia
Table 4: MIN-101 sales for schizophrenia in the US ($m), 2017-26