New CGRP Drug Tastes Success In Last Stage Clinical Trials, To Hit Markets Soon

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New Drug Can Stop A Migraine From Occurring (1)

The role of CGRP or Calcitonin Gene-related Peptide has been implicated in migraine research since 3 decades now. However, the exact nuisances to trace the working of CGRP and then tame it’s effects during a migraine attack was being studied and at times led to hopes for migraineurs but further tests on those hypotheses on which some of the drugs worked, failed.

CGRP is basically a neurotransmitter that is produced by cells in our central nervous system (CNS) and also by peripheral neurons. As the name suggests, it is a peptide or a chain wherein several amino acid molecules are linked to each other. CGRP’s main function is to cause vasodilatation or swelling of cranial arteries and cranial membrane, and transmission of pain. (2)

When CGRP is released by the CNS neurons into our blood, it is affected by two types of receptors: Calcitonin receptor-like receptor (CALCRL) and, a receptor activity-modifying protein (RAMP1).

Over the years drugs have been made to block these receptors during a migraine episode with new drugs but they have been found to be too toxic for the human liver. Currently, a few pharmaceutical corporations such as Amgen/Novartis, Teva and Eli Lilly are in the brink of bringing revolutionary CGRP drugs that work for us without unleashing a series of serious side effects.

Based on the data obtained on its 2 successful phases of trials of their new drug (galcanezumab), Eli Lilly concluded that in episodic and chronic migraine, a 50% reduction was seen in around 60% of patients on galcanezumab versus 36%-39% of placebo users, with all migraine attacks eliminated in 12%-15% and 6%, respectively.

As per the Christi Shaw, President at Lilly Bio-Medicines, “the findings are a crucial step forward for the millions of patients living with migraine that have not yet tried, or found, an effective preventive therapy.” (3)

At the moment, Lilly is trying to differentiate galcanezumab with the drugs from the pharma companies who are in the run for licenses to sell, on the basis of its Phase III program in cluster headaches which is due to read out next year, and has said it hopes galcanezumab will be the first drug in its class with pivotal data in this indication.

As per Peter Goadsby, neurologist at King’s College London an UCSF is of the opinion that, “We’re in a genuine watershed moment with the very first class of migraine treatments that can prevent the attacks from actually happening. It’s incredibly encouraging and provides much needed hope to people who continue to struggle despite a range of currently available treatments.” (4) He noted this of all the CGRP-based therapies by the different pahrma companies that were possibly to hit the market.

In the meanwhile, Lilly has acquired CoLucid with it’s lead drug lasmiditan. Lasmiditan is to arrive in 2018 as an orally taken 5-HT 1F receptor agonist against acute migraine attacks. Data reported on this drug have been favourable and were reported at the AHS meeting. It was noted that significantly more participants were free of headache pain and other symptoms such as nausea, or aversion to loud sounds or light two hours after treatment with lasmiditan, compared to placebo.

SOURCES:

  1. Picture Credit: FreeDigitalPhotos; “Stressed Businesswoman” by Ambro; http://www.freedigitalphotos.net/images/agree-terms.php
  2. Calcitonin Gene-related Peptide; Wikipedia; https://en.wikipedia.org/wiki/Calcitonin_gene-related_peptide
  3. Lilly’s CGRP Inhibitor Galcanezumab Hits The Mark In Migraines As Race To Market Kicks Off; Fierce Biotech; Phil Taylor; June 2017; http://www.fiercebiotech.com/biotech/lilly-s-cgrp-inhibitor-galcanezumab-hits-mark-migraine-as-race-to-market-kicks-off
  4. AHS Meeting Release CGRP; 59th Annual Scientific Meeting; https://americanheadachesociety.org/ahs-meeting-release-cgrp/

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