Neuropeptides

U.S. Food and Drug Administration Grants Breakthrough Therapy Designation to Takeda’s Investigational Compound, TAK-994, an Oral Orexin Agonist in Clinical Development for Narcolepsy Type 1 (NT1)

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Wednesday, July 28, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (Takeda) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors.

Key Points: 
  • Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (Takeda) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors.
  • Individuals with narcolepsy type 1 suffer from excessive daytime sleepiness, which might mean routinely falling asleep at work or in school.
  • This designation marks a key milestone in Takedas accelerated development efforts to bring this important potential therapy to patients with NT1.
  • A Study of TAK-994 in Participants With Narcolepsy With or Without Cataplexy (Narcolepsy Type 1 [NT1] or Narcolepsy Type 2 [NT2]).

NeRRe Therapeutics raises £20 million in a Series B2 financing round

Retrieved on: 
Wednesday, July 7, 2021

Stevenage, UK, 7 July 2021 NeRRe Therapeutics, a clinical-stage company developing orvepitant, its wholly-owned neurokinin-1 (NK-1) antagonist, as a first in class treatment for disabling chronic cough caused by reflex hypersensitivity disorders, today announces it has raised an additional 20 million in a Series B2 financing round.

Key Points: 
  • Stevenage, UK, 7 July 2021 NeRRe Therapeutics, a clinical-stage company developing orvepitant, its wholly-owned neurokinin-1 (NK-1) antagonist, as a first in class treatment for disabling chronic cough caused by reflex hypersensitivity disorders, today announces it has raised an additional 20 million in a Series B2 financing round.
  • The proceeds from the financing round will primarily be used to fund the Phase 2 clinical development of orvepitant as a treatment for chronic cough associated with IPF.
  • NeRRe Therapeutics is a clinical-stage company developing orvepitant, a neurokinin(NK)-1 receptor antagonist, as a first in class, once daily breakthrough treatment for cough hypersensitivity disorders.
  • Fountain Healthcare Partners is a life science focused venture capital fund with EUR 300 million (USD 354 million) under management.

NeRRe Therapeutics raises £20 million in a Series B2 financing round

Retrieved on: 
Wednesday, July 7, 2021

Stevenage, UK, 7 July 2021 NeRRe Therapeutics, a clinical-stage company developing orvepitant, its wholly-owned neurokinin-1 (NK-1) antagonist, as a first in class treatment for disabling chronic cough caused by reflex hypersensitivity disorders, today announces it has raised an additional 20 million in a Series B2 financing round.

Key Points: 
  • Stevenage, UK, 7 July 2021 NeRRe Therapeutics, a clinical-stage company developing orvepitant, its wholly-owned neurokinin-1 (NK-1) antagonist, as a first in class treatment for disabling chronic cough caused by reflex hypersensitivity disorders, today announces it has raised an additional 20 million in a Series B2 financing round.
  • The proceeds from the financing round will primarily be used to fund the Phase 2 clinical development of orvepitant as a treatment for chronic cough associated with IPF.
  • NeRRe Therapeutics is a clinical-stage company developing orvepitant, a neurokinin(NK)-1 receptor antagonist, as a first in class, once daily breakthrough treatment for cough hypersensitivity disorders.
  • Fountain Healthcare Partners is a life science focused venture capital fund with EUR 300 million (USD 354 million) under management.

Teva Announces Ministry of Health, Labour and Welfare Approves AJOVY® (fremanezumab) Injection in Japan for the Preventive Treatment of Migraine in Adults

Retrieved on: 
Wednesday, June 23, 2021

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan.

Key Points: 
  • Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan.
  • Driven by our global mission to improve patients lives, we are pleased to offer this new treatment option to people living with migraine in Japan.
  • In 2020, the two companies announced outcomes from two pivotal studies of AJOVY in people living with episodic and chronic migraine in Japan.
  • AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.

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

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Wednesday, June 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.

NLS Pharmaceutics Announces New Study Data Confirming Mazindol's Unique Orexin Pathway Activation for Treating Narcolepsy

Retrieved on: 
Tuesday, May 18, 2021

Narcolepsy is caused by a deficiency in orexin, a neuropeptide that regulates the sleep-wake cycle.

Key Points: 
  • Narcolepsy is caused by a deficiency in orexin, a neuropeptide that regulates the sleep-wake cycle.
  • NLS believes that the new data also support prior in-vitro data from studies conducted by the Company demonstrating the partial binding affinity of mazindol to OX2R, which NLS believes is a key pathway that mediates mazindol\'s stimulant-like effects.
  • We believe that Quiliencewill provide a differentiated solution in this treatment category given mazindol\'s dual mechanism of action, namely orexin pathway activation and pan-monoaminergic reuptake inhibition in the brain.
  • NLS completed a Phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD.

Global Cancer Anorexia Market Outlook to 2030: Epidemiology, Drugs, Unmet Needs, Pipeline & Development Activities, Competition

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Monday, April 12, 2021

Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite, and metabolism.

Key Points: 
  • Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, muscle mass, appetite, and metabolism.
  • Anamorelin has shown effects in increasing body weight and muscle mass, as well as appetite in patients with cancer cachexia.
  • Moreover, the emerging pipeline of cancer anorexia is quite weak, with three promising lead candidates in the late and early stages of development.
  • They will require few years to be investigated and launched in the market as potential therapeutic treatment options for cancer anorexia.\n5 Disease Background and Overview: Cancer Anorexia\n'

Crinetics Pharmaceuticals Showcasing Breadth of Pipeline at ENDO 2021 with Presentations on Three Clinical Programs

Retrieved on: 
Friday, March 12, 2021

SAN DIEGO, March 12, 2021 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, announced upcoming oral and poster presentations at the Endocrine Societys annual ENDO 2021 congress.

Key Points: 
  • SAN DIEGO, March 12, 2021 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, announced upcoming oral and poster presentations at the Endocrine Societys annual ENDO 2021 congress.
  • Preclinical evidence supporting the companys development of its selective somatostatin receptor type 5 (SST5) agonist, CRN04777, for the treatment of congenital hyperinsulinism was selected for a late-breaking e-poster presentation.
  • The poster and oral presentations will be made available on the Crinetics website following the conclusion of the congress.
  • For ENDO attendees, Crinetics staff will also be available to address questions and discuss pipeline programs in the virtual exhibit hall.

NT-814 by Bayer: A Non-Hormonal, Orally Administered, Potent and Selective Small Molecule Dual Antagonist of Neurokinin-1 and 3 receptors - Global Emerging Insight and Market Forecast to 2030 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, March 10, 2021

The "NT-814 - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "NT-814 - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
  • NT-814 is a non-hormonal, orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors.
  • "NT-814 - Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Vasomotor symptoms in 7 Major Markets.
  • Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies.

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

Retrieved on: 
Friday, February 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.