Sage Faces Multiple Moments Of Truth For Zuranolone, GABA Modulation

Parkinson’s Data For NMDA Modulator Also On Tap Before Year’s End

Before pivotal depression data in 2021 attempt to redeem zuranolone after a failed Phase III study, the company will report Phase II results for next-gen GABA modulator SAGE-324 in essential tremor.

A man standing on top of a mountain as the sun sets
Sage may get a shot at redemption with zuranolone in depression • Source: Shutterstock

Three pivotal studies reading out in 2021 could redeem Sage Therapeutics, Inc.’s zuranolone (SAGE-217) following its failure in the acute treatment of major depressive disorder at the end of last year. Before then, however, Phase II results for its next-generation drug SAGE-324 in chronic treatment of essential tremor could reinforce the company’s confidence in its GABA-modulation approach to mood and movement disorders.

Three Phase III clinical trials of zuranolone are under way in two different major depressive disorder (MDD) settings and in postpartum depression (PPD) with results due next year. Top-line data for SAGE-324 in essential tremor are expected in late 2020 or early 2021, which means those results could be preceded by Phase IIa results for SAGE-718

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Neurological

Accelerated Approval May Be Out Of Reach For PTC’s Huntington’s Drug

 
• By 

PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.

In Brief: Ferrer Signs Deal For Prilenia’s Pridopidine In Europe

 

The companies will co-develop the drug for additional indications beyond Huntington’s disease, while Prilenia retains rights in key global markets.

CNS, Cardiometabolics A Bright Spot In Recent Chinese VC/PE Fundings

 

Over the past few months, Chinese developers of CNS and cardiometabolic therapies have attracted the interest of domestic investors, amid generally modest funding activity.

In Brief: Bioxodes To Take Novel Hemorrhagic Stroke Drug Into Registrational Trial

 

The Belgium-based firm will take the first-in-class drug, based on tick saliva, targets inflammation without increasing bleeding, into a Phase IIb trial is in preparation, supported by a new series B funding round.

More from Therapy Areas

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By 

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Zepbound Grows, But CVS/Novo Nordisk Deal For Wegovy Casts Shadow

 

Lilly executives told the company’s Q1 call they were not surprised at the Wegovy deal, but some analysts said it could cut into prescription growth for Zepbound.

GSK Talks Up Nucala COPD Hospitalization Data In Challenge To Dupixent

 
• By 

As the PDUFA date for the UK major’s IL-5 inhibitor draws close.