First Patient Dosed in Trial Testing Safety, Efficacy of SAR442168 in RRMS

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First Patient Dosed in Trial Testing Safety, Efficacy of SAR442168 in RRMS

The first patient was dosed in a clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 therapy candidate in relapsing MS patients.

The first patient has been dosed in a Phase 2B clinical trial evaluating the safety, efficacy, and tolerability of SAR442168 in people with relapsing multiple sclerosis (MS). SAR442168, formerly known as PRN2246, is being developed by Principia Biopharma, in collaboration with Sanofi Genzyme, for MS and other central nervous system (CNS) disorders.

The Phase 2B trial (NCT03889639) also is a dose-finding study to determine what SAR442168 dose is most effective without causing serious adverse events.

“We are delighted that the first patient has been dosed in Sanofi’s Phase 2b dose-finding trial in patients with relapsing multiple sclerosis,” Martin Babler, president and CEO of Principia, said in a press release.

SAR442168 is designed to cross the blood-brain barrier, and block Bruton’s tyrosine kinase (BTK) — an important signaling molecule that triggers the proliferation of immune B-cells in the brain, and promotes neuroinflammation. The BTK-mediated increase in the number of B-cells, and the associated brain inflammation, is linked to the damage found in MS and other CNS disorders.

SAR442168 treatment thus has the potential to specifically regulate cells that drive CNS autoimmunity and inflammation processes.

Results from an Australian Phase 1 study (ACTRN12617001457336) in healthy volunteers showed that SAR442168 was well-tolerated by the participants. Importantly, the therapy was found in the cerebrospinal fluid (present in the brain and spinal cord), indicating that this experimental therapeutic can successfully cross the blood-brain barrier — a shield that protects the brain from toxins and pathogens that may be present in the blood.

The ability to cross the blood-brain barrier is vital for any therapeutic that aims to have an impact on brain cells.

Read on: First Patient Dosed in Trial Testing Safety, Efficacy of SAR442168 in RRMS

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