1. Scrip
  2. >>Advanced Therapies
  3. >>Gene Therapies

Pfizer Planning To Start Phase III DMD Gene Therapy Trial, With Safety Monitoring Protocols

 
• By Jessica Merrill

Updated Phase Ib data showed safety issues due to complement activation, but Pfizer is confident the benefits outweigh the risks and monitoring systems will help as it moves into Phase III.

Caution sign
Positive efficacy signals but safety risks too with Pfizer's DMD gene therapy • Source: Shutterstock

Pfizer Inc. will begin enrolling boys with Duchenne muscular dystrophy in a Phase III clinical trial in the second half of 2020, despite serious cases of complement activation in boys treated with the experimental gene therapy in Phase Ib.

Pfizer will initiate a Phase III clinical trial testing its gene therapy PF-06939926 in the second half of 2020 with protocols in place to monitor safety, the firm said. The...

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
Start Free Trial

Already a subscriber?

More from Gene Therapies

More from Advanced Therapies

Which Firms Are Most Exposed To Prasad’s Possible Accelerated Approvals Clampdown?

 
• By Andrew McConaghie

Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.

Atara Does An About Face As FDA Lifts Ebvallo Hold

 
• By Alaric DeArment

The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.

Zelluna Believes Its TCR Tech Can Unlock Natural Killer Cell Potential

 
• By Andrew McConaghie

While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology