Anti-LINGO-1 / BIIB033 / Opicinumab for RRMS

OpicinumabĀ (also known as anti-LINGO-1 and BIIB033) is anĀ investigationalĀ monoclonal antibody being developed by BiogenĀ toĀ promote the remyelination of nerve cells in people with remitting-relapsing multiple sclerosis (RRMS).

HowĀ opicinumab works

MS is characterized by demyelination, or loss of the myelin sheath, a protective layer that surrounds the nerve fibers. This interrupts and blocks the passage of electrical signals through the nerve cells. In earlier stages of MS, oligodendrocytes (cells that make and maintain the myelin coating) can repair the damaged myelin, but as the disease progresses,Ā oligodendrocytes either stop functioning or die, and they stop repairingĀ myelin.

The brain and the spinal cord have a unique protein calledĀ LINGO-1Ā that prevents immature cells from becoming oligodendrocytes. Opicinumab is an antibody (a protein designed to target and bind to a specific protein), which blocks the action of LINGO-1 (hence the name, anti-LINGO-1), allowing these cells to mature into oligodendrocytes. These new oligodendrocytes may help restore the damaged myelin and prevent permanent nerve damage, which causes further disability in patients.

Opicinumab in clinical trials

A Phase 2 study called RENEW (NCT01721161), assessed the effectiveness, safety, and tolerability of opicinumab in 82 peopleĀ with acute optic neuritis, a condition highly associated with MS and characterized by the inflammation and demyelination of the optic nerve ā€” the bundle of nerves that transmits visual information from the eye to the brain.

Although theĀ results of the study showedĀ no improvements in vision in people taking opicinumabĀ compared to those taking a placebo, there was a slight improvement and statistically significant change in the amount ofĀ time it took for a signal to travel from the eye to the brain. This finding suggested repairs toĀ the myelin sheath around the optic nerve. The results were published in the scientific journal Lancet Neurology.

A follow-up study calledĀ RENEWed (NCT02657915) assessedĀ the long-term effects of a potential remyelinating therapyĀ in participants who took part in the RENEW trial, two years and four months after that trial was concluded. RENEWed, whichĀ ended inĀ January 2017, assessedĀ eye evoked potentialĀ latency (or the delay in electric signals in response to a light stimulus), as well as the clinical progression and severity of demyelination in patients. Results have not yet been published.

Another Phase 2 study called SYNERGY (NCT01864148) assessed the effectiveness, safety, tolerability, and pharmacokinetics of opicinumab inĀ 418 RRMS patients being treated concurrently withĀ Avonex (interferon beta-1a).Ā Patients received either 3 mg, 10 mg, 30 mg, or 100 mg/kg body weight of opicinumab every four weeks for a period of 72 weeks.

Initial results from Biogen suggestedĀ thatĀ opicinumab did not improve physical or cognitive disability, lead to a slowdown in the progression of disability. However, patients treated with intermediate doses of opicinumab (10 and 30mg/kg) showed a 65.6 percent and 68.8 percent improvement in Expanded Disability Status Scale (EDSS) scores, compared to an improvement of 51.6 percent in the placebo group. These results were presented at the 2017 American Academy of Neurology (AAN) Annual Meeting.Ā 

NoĀ serious adverse effects of the treatmentĀ were reportedĀ in any of the studies.

Biogen intends to continue trials withĀ opicinumab, potentially in conjunction with anti-inflammatory drugs such as Tysabri (natalizumab).

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