Akashi Therapeutics cleared to resume Duchenne candidate clinical development in USA

23 March 2017
2019_biotech_test_vial_discovery_big

There was good news for US clinical-stage biotech Akashi Therapeutics yesterday, when it received permission to resume development of its Duchenne drug candidate.

The company said that the US Food and Drug Administration has completed its review and concluded that Akashi may resume clinical development of HT-100 (delayed-release halofuginone) in patients with any of the genetic mutations that cause Duchenne muscular dystrophy (DMD), a rare disease that results in muscle degeneration and premature death in boys. Akashi plans to initiate a new study, HALO-DMD-04.

Privately-held Akashi halted an early-stage trial of HT-100 in January 2016 after one patient experienced what the company called “serious, life-threatening health issues.” A week later, the company disclosed that the patient had died.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Today's issue

Company Spotlight





More Features in Biotechnology