GeNeuro, a biopharmaceutical company, developing new treatments for neurological and autoimmune diseases such as multiple sclerosis (MS) and type-1 diabetes, has announced positive safety and tolerability results from a Phase 1 study assessing the administration of high doses of temelimab (GNbAC1) to treat MS and other auto-immune diseases.
In this randomised, double-blind and placebo-controlled study of 24 healthy volunteers, four cohorts received doses of GNbAC1 ranging from 36 mg/kg to 110 mg/kg. The results of the study showed that no adverse events related to drug safety occurred and that pharmacokinetic data were linear for all doses tested.
The study builds on data from the CHANGE-MS Phase 2b trial, which demonstrated that only the highest dose tested, 18 mg/kg, was effective. These results suggest that higher dose regimens or a front-loading could be evaluated in the next clinical study of temelimab in MS and other potential therapeutic indications.
In addition, GeNeuro confirmed that the World Health Organization (WHO) has assigned the International Nonproprietary Name (INN) “temelimab” to GNbAC1.
In October 2018, in the Congress of the European Committee for Treatment and Research on Multiple Sclerosis held in Berlin (ECTRIMS 2018), GeNeuro announced that final analysis of the Phase 2b CHANGE-MS clinical study had produced robust results regarding key markers related to MS progression, and that the effects were greater in patients who did not experience inflammatory activity during the study. These patients represent a group of MS patients who are not well served by currently available therapies. The CHANGE-MS results suggest temelimab has the potential to become a totally new mechanism of action targeting a cause of MS progression. Furthermore, they suggest that temelimab could be used as a single agent in patients experiencing progressive MS without active inflammation, or synergistically with existing anti-inflammation MS drugs.
Source: MS-UK, 28/01/2019