GeNeuro has reported positive data from a Phase 1 clinical trial (NCT03574428) evaluating the safety and tolerability of high doses of GNbAC1, developed for the treatment of neurological and autoimmune disorders, including multiple sclerosis (MS).
The company also announced that the World Health Organization has assigned the international nonproprietary name “temelimab” to GNbAC1.
The development of temelimab is the result of a quarter century of research into human endogenous retroviruses, which are stretches of foreign, viral DNA inserted into the human genome. Some human endogenous retroviruses are known to be associated with auto-immune diseases. For example, one of these viruses, the MS-associated retrovirus (MSRV), encodes a protein (MSRV-envelope protein, or MSRV-Env) that is found in MS patients, particularly in active lesions.
Temelimab, a monoclonal antibody, works by neutralizing the MSRV-Env protein associated with MS, and subsequently blocks inflammation. Also, the therapy was shown to restore myelin, which is the insulating sheath around nerve fibers that is compromised in MS patients.
This new trial follows a previous GeNeuro clinical trial testing temelimab in the treatment of MS, the CHANGE-MS study (NCT02782858). In October 2018, GeNeuro announced the final results of this Phase 2b study, showing that temelimab could reduce the levels of key markers related to MS progression, lessen brain atrophy and lesion load, and protect the nervous system.
In the CHANGE-MS study, three temelimab doses were tested: 6, 12, and 18 mg/kg. Only the highest dose (18 mg/kg) was effective in blocking MS disease progression; the lower doses had no noticeable effects. This suggested that further clinical studies were needed to evaluate the safety of higher doses.
Now, in the Phase 1 trial, GeNeuro tested the safety of temelimab at a higher dose range. Four doses were tested: 36, 60, 85, and 110 mg/kg. The trial was a randomized, double-blind, placebo-controlled study with 24 healthy volunteers.
Results showed that no adverse events (side effects) related to safety occurred when taking temelimab at all the higher doses tested, suggesting that the therapy had a robust safety profile even at higher doses.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?