Calcitonin – Gene Related Peptide (CGRP) Antagonists /Monoclonal Antibodies: New Targeted Therapies for Migraine

February 2018 | 33 pages | ID: CFC6B095D1CEN
ProGrow Pharma Partners

Abstracts

Migraine has been recognized as a highly disabling neurological pain disorder and its management is often challenging! Despite it being more prevalent than diabetes, epilepsy and asthma combined, efficacious drugs for treating migraine are still wanting. Better drugs for diabetes and asthma have been launched in the last decade but migraine is still being served mostly by the triptan class of drugs launched in the 90’s! Current treatments, preventive and therapeutic, are not specific and hence efficacy, safety, and tolerability are unsatisfactory. Nearly half of individuals with episodic or chronic migraine who are in need of preventive therapies do not receive them. Migraine remains undiagnosed and undertreated in at least 50% of patients, and less than 50% of migraine patients consult a physician.Growing awareness of the unmet need in migraine has given momentum to the research and understanding of the molecular pathway and physiology of the disease. Novel mechanisms, such as, 5-hydroxytriptamine (5-HT) receptors, Calcitonin-Gene Related Peptide (CGRP), pituitary adenylate cyclase-activating polypeptide (PACAP), Glutamate etc, show promise for relieving symptoms and may provide more effective treatment option in the near term.CGRP is an extensively studied neuropeptide that has been implicated in the pathophysiology of migraine. Over 20 years of intense research on the target (CGRP) translated into what may be the first class of medications being developed specifically for the prevention of migraine in over 50 years! Several small molecule antagonists against the CGRP receptor demonstrated that targeting this pathway is a valid and effective way of treating migraine.In this report, we highlight the advances made in the understanding of the biology of migraine and development of new drugs for Migraine. Besides new targets, novel drug delivery systems for off patent drugs, devices also are available for the patients.

We discuss why CGRP is a promising target for the prevention of migraine and describe four monoclonal antibodies against either CGRP or its receptor that are in clinical development for the treatment of both episodic and chronic migraine. A comprehensive comparison of clinical data and properties of some of the potential drugs in the pipeline is included in the report.Most of the major CNS players have a drug targeting CGRP in their pipeline. The launch of anti CGRP could probably represent a turning point for prevention similar to that represented by triptans for abortive treatment in migraine. Considering the WW high prevalence of migraine, the market opportunity is immense. The commercial opportunity is discussed in the report.

Contents

1. EXECUTIVE SUMMARY

2. TARGETING CALCITONIN GENE-RELATED PEPTIDE (CGRP) IN MIGRAINE

Rationale for Targeting CGRP
Biology: Structure and Molecular Genetics of CGRP
Development of CGRP Antagonists for the Treatment of Migraine
Non-Tritpan Drugs and Other “Me-too’s” in the Pipeline
Commercial Opportunity
  a. Who will lead in the CGRP mAb Race?
  b. Marketing Strategy will be the Key!
Merger and Acquisitions / Licensing Opportunity

3. MIGRAINE

Overview of the Disease
Pathophysiology of the Disease
Epidemiology
Subtypes of Migraine
Signs and symptoms of Migraine
Causes of Migraine
Risk factors
Diagnosis and Current Treatment Paradigm
Unmet need