CALCRL

Sosei Heptares Initiates Phase 1 Trial With Novel Small-Molecule CGRP Antagonist Under Collaboration With Biohaven

Retrieved on: 
Mercredi, juin 23, 2021

Sosei Heptares has advanced HTL0022562 successfully though a preclinical development program demonstrating its promising and differentiated properties for further investigation in human trials.

Key Points: 
  • Sosei Heptares has advanced HTL0022562 successfully though a preclinical development program demonstrating its promising and differentiated properties for further investigation in human trials.
  • Under the global collaboration and license agreement with Biohaven, Sosei Heptares will conduct the Phase 1 clinical trial itself, receiving a milestone payment for its initiation, and is also eligible for development costs for conducting the trial.
  • Biohaven will lead all future studies and development activities and Sosei Heptares will be eligible for further milestone payments and royalties.
  • Sosei Heptares and Biohaven entered a global collaboration and license agreement in December 2020 under which Biohaven received exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders.

FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment

Retrieved on: 
Jeudi, mai 27, 2021

This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment.

Key Points: 
  • This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment.
  • NURTEC ODT is approved for acute treatment in all eligible adult patients with migraine, regardless of the number of monthly migraine days.
  • NURTEC ODT, with its novel quick-dissolve tablet formulation, works by blocking the CGRP receptor, treating a root cause of migraine.
  • It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine.

New Study Published in Cephalalgia Identifies Mechanistic Differences Among CGRP Migraine Treatments

Retrieved on: 
Vendredi, février 26, 2021

This study demonstrated marked differences in the mechanism of blocking the calcitonin gene-related peptide (CGRP) ligand versus the CGRP receptor.

Key Points: 
  • This study demonstrated marked differences in the mechanism of blocking the calcitonin gene-related peptide (CGRP) ligand versus the CGRP receptor.
  • For instance, fremanezumab in particular, as a monoclonal antibody against the CGRP ligand, is targeted and specific in its mechanism.
  • AJOVY (fremanezumab-vfrm) injection is a fully humanized IgG2A monoclonal antibody that specifically and solely targets CGRP, a key neuropeptide involved in the pathophysiology of migraine.
  • Clinical implications of these findings are unknown, but the in vitro studies provide insights into potential mechanistic differences.

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

Retrieved on: 
Mardi, décembre 1, 2020

Under the agreement, Biohaven will receive exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders.

Key Points: 
  • Under the agreement, Biohaven will receive exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders.
  • In addition, Sosei Heptares will be eligible to receive tiered royalties on net sales of products resulting from the collaboration.
  • Vlad Coric, M.D., Chief Executive Officer of Biohaven, said: "We are excited to enter into this agreement with Sosei Heptares, a world leader in GPCR drug discovery.
  • Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented:"We are delighted to enter this collaboration and license agreement with Biohaven for our portfolio of novel CGRP receptor antagonists.

AbbVie to Present New Data From 15 Abstracts at the 2020 Virtual Migraine Trust International Symposium

Retrieved on: 
Vendredi, octobre 2, 2020

In total, 15 abstracts will be presented evaluating the safety, efficacy, and impact on patients and the healthcare system of AbbVie's migraine treatment portfolio, including BOTOX (onabotulinumtoxinA) and UBRELVY(ubrogepant).

Key Points: 
  • In total, 15 abstracts will be presented evaluating the safety, efficacy, and impact on patients and the healthcare system of AbbVie's migraine treatment portfolio, including BOTOX (onabotulinumtoxinA) and UBRELVY(ubrogepant).
  • Findings from nine abstracts evaluating treatment with BOTOX in clinical and real-world settings will be presented as posters, also available on demand October 3-9.
  • Atogepant is an investigational orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine.
  • Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

AbbVie to Showcase 27 Studies at the Virtual 2020 Annual Scientific Meeting of the American Headache Society

Retrieved on: 
Lundi, juin 15, 2020

NORTH CHICAGO, Ill., June 15, 2020 /PRNewswire/ --AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it has 27 studies accepted to the virtual 2020 Annual Scientific Meeting of the American Headache Society (AHS).

Key Points: 
  • NORTH CHICAGO, Ill., June 15, 2020 /PRNewswire/ --AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it has 27 studies accepted to the virtual 2020 Annual Scientific Meeting of the American Headache Society (AHS).
  • We are thankful the American Headache Society continues to recognize these significant scientific advancements."
  • UBRELVY, approved in December of 2019, is a first-to-market, orally-administered CGRP receptor antagonist (or gepant) for the acute treatment of migraine.
  • Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

2020 Insights into Calcitonin Gene Related Peptide Type 1 Receptor - Featuring Adepthera, Allergan and Amgen Among Others

Retrieved on: 
Mercredi, mars 25, 2020

According to this report the Calcitonin Gene Related Peptide Type 1 Receptor (Calcitonin Receptor Like Receptor or CALCRL) pipeline Target constitutes close to 6 molecules.

Key Points: 
  • According to this report the Calcitonin Gene Related Peptide Type 1 Receptor (Calcitonin Receptor Like Receptor or CALCRL) pipeline Target constitutes close to 6 molecules.
  • Calcitonin Gene Related Peptide Type 1 Receptor (Calcitonin Receptor Like Receptor or CALCRL) - Calcitonin receptor-like (CALCRL) also known as the calcitonin receptor-like receptor (CRLR) is a G protein-coupled receptor.
  • The report 'Calcitonin Gene Related Peptide Type 1 Receptor - Pipeline Review, H1 2020' outlays comprehensive information on the Calcitonin Gene Related Peptide Type 1 Receptor (Calcitonin Receptor Like Receptor or CALCRL) targeted therapeutics, complete with analysis by indications, stage of development, mechanism of action (MoA), route of administration (RoA) and molecule type; that are being developed by Companies / Universities.
  • It also reviews key players involved in Calcitonin Gene Related Peptide Type 1 Receptor (Calcitonin Receptor Like Receptor or CALCRL) targeted therapeutics development with respective active and dormant or discontinued projects.

Allergan Receives U.S. FDA Approval for UBRELVY™ for the Acute Treatment of Migraine with or without Aura in Adults

Retrieved on: 
Lundi, décembre 23, 2019

UBRELVY is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start.

Key Points: 
  • UBRELVY is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they start.
  • In clinical trials supporting the FDA's approval, UBRELVYprovided quick pain relief for the majority of migraine patients.
  • UBRELVY works in a new way by blocking CGRP, a protein that is released during a migraine attack, from binding to its receptors.
  • UBRELVYTM(ubrogepant) is indicated for the acute treatment of migraine with or without aura in adults.

FDA approves new treatment for adults with migraine

Retrieved on: 
Lundi, décembre 23, 2019

It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.

Key Points: 
  • It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists approved for the acute treatment of migraine.
  • "Ubrelvy represents an important new option for the acute treatment of migraine in adults, as it is the first drug in its class approved for this indication.
  • The FDA is pleased to approve a novel treatment for patients suffering from migraine and will continue to work with stakeholders to promote the development of new safe and effective migraine therapies."
  • Patients were allowed to take their usual acute treatment of migraine at least two hours after taking Ubrelvy.

Biohaven Achieves Positive Topline Results in Pivotal Phase 2/3 Study of Vazegepant, The First and Only Intranasal CGRP Receptor Antagonist in Clinical Development for the Acute Treatment of Migraine

Retrieved on: 
Mardi, décembre 17, 2019

This shows our ability to execute on clinical trials, now delivering our 4th consecutive positive pivotal trial in migraine."

Key Points: 
  • This shows our ability to execute on clinical trials, now delivering our 4th consecutive positive pivotal trial in migraine."
  • Dr. Coric added, "We are excited to demonstrate the efficacy and tolerability of the first intranasal CGRP receptor antagonist for patients with migraine.
  • Biohaven is grateful to the patients and investigators who have contributed to the success of the vazegepant and rimegepant programs."
  • Vazegepant is the newest member of Biohaven's NOJECTIONTM Migraine Platform to have demonstrated efficacy in a pivotal trial.