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Opicinumab

Opicinumab is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Opicinumab rather than just read about it. In short: Opicinumab (BIIB033) is a fully human monoclonal antibody designed for the treatment of multiple sclerosis, acute optic neuritis (AON), and other associated demyelinating diseases. A biologic drug, it is designed to function as a LINGO-1 protein antagonist, known as "Anti-Lingo-1".

Key takeaways

  • Opicinumab belongs to science; place it in that map before memorising details.
  • Learn the definition first, then one example that makes the definition concrete.
  • Connect Opicinumab to a quantity you can measure, compute or draw — that is where exam questions come from.
  • Reproduce the core statement of Opicinumab from memory before moving on to harder problems.

Reference excerpt

Opicinumab (BIIB033) is a fully human monoclonal antibody designed for the treatment of multiple sclerosis, acute optic neuritis (AON), and other associated demyelinating diseases. A biologic drug, it is designed to function as a LINGO-1 protein antagonist, known as "Anti-Lingo-1". Some Phase II clinical trials have been carried out, but preliminary results indicate that primary study endpoints were not met and that opicinumab exhibits unexpected dose-response relationships. Further studies were planned by the company, as opicinumab still was deemed to show potential for clinical efficacy in the treatment of MS.

Mechanism of action Opicinumab is designed to prevent the advancement of demyelination associated with neurodegenerative disorders, specifically MS. It is believed to function by allowing young cells, which would normally be prevented from maturing by the LINGO-1 protein, to mature into functional oligodendrocytes. Oligodendrocytes support nerve axons and serve to maintain the myelin sheath that allows for the effective conduction of axon potentials. LINGO-1 is only found in the Central Nervous System (CNS) and is thought to be at least a partial causative agent of MS, an autoimmune disorder. It is thought that by allowing oligodendrocytes to mature, further disability advancement caused by MS can be prevented, with reversal of demyelination associated with MS potentially achievable.

Clinical trials Phase I and Phase II clinical trials are currently ongoing for opicinumab. Completed Phase I trials assessed safety and efficacy in healthy people and in MS patients, as well as investigated pharmacokinetic parameters of the drug. Biogen has an ongoing Phase 1 trial that is investigating the safety of ocipinumab produced via two different manufacturing processes in healthy individuals. That trial is set to conclude November 2016.

Acute optic neuritis The completed Phase II trial, dubbed RENEW by Biogen, studied the potential clinical efficacy of opicinumab in treating AON, more specifically in repairing damage done to the optic nerve. The study successfully reached its primary endpoint and showed a 34 percent partial recovery of optic nerve latency, a measure of the time of conduction from the retina to the visual cortex. On RENEW's secondary endpoint, there was no statistically significant change in either visual function or retinal thickness.

Multiple sclerosis The second completed Phase II clinical trial for opicinumab, called SYNERGY by Biogen, concluded in March 2016 but failed to reach its primary endpoint, which was an integrated measure of several MS progression and disability markers: ambulation, extremity functionality, cognition, and other typical indicators of MS. Results from the study also showed highly unanticipated dose-response relationships in the MS patient population that will likely require further clinical trials to investigate satisfactorily.

Intellectual property Biogen, Inc. filed its first patent application with WIPO (World Intellectual Property Organization) in 2008, wherein the potential to target LINGO-1 in patients with MS was described. In January 2016, Biogen filed a second patent application with WIPO that specifically described and protected BIIB003 (opicinumab). By filing with WIPO, the overseeing organization for the Patent Cooperation Treaty (PCT), Biogen gains an extra year of intellectual property (IP) exclusivity after submitting its international patent application with WIPO to apply for patents in all desired member states of the PCT. Therefore, Biogen has until January 2017 to file patent applications for opicinumab in multiple countries of its choosing, after which its IP will no longer be protected by the PCT.

References

Worked examples

Example 1 — a first encounter with Opicinumab

Start with the simplest possible case. Write down what Opicinumab claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Opicinumab before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Opicinumab ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Opicinumab

In research
Opicinumab appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry
Engineering practice reuses Opicinumab in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom
Opicinumab is common in secondary-school and first-year university syllabi. It links to neighbouring topics Drugs not assigned an ATC code, Monoclonal antibodies, so understanding it makes those chapters shorter.
In everyday life
Look for Opicinumab outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.
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How to study Opicinumab in 20 minutes

  1. Read the reference excerpt below once, without taking notes.
  2. Close the page and write down what Opicinumab means in your own words.
  3. Compare your version with the excerpt and mark what you missed.
  4. Work through the three examples above with pen and paper.
  5. Explain Opicinumab out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Opicinumab in simple terms?

Opicinumab (BIIB033) is a fully human monoclonal antibody designed for the treatment of multiple sclerosis, acute optic neuritis (AON), and other associated demyelinating diseases. A biologic drug, it is designed to function as a LINGO-1 protein antagonist, known as "Anti-Lingo-1".

Why does Opicinumab matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Opicinumab?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Opicinumab.

Tags

  • Drugs not assigned an ATC code
  • Monoclonal antibodies

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