Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Helixmith Mods Engensis Trial Plans As Probe Unravels PK Anomalies

Pushing Ahead With Phase III Gene Therapy Program

Executive Summary

After probing pharmacokinetic data flaws in the first US Phase III study for its gene therapy Engensis, Korea's Helixmith concludes that these stemmed from clinical operation issues. As a result, it admits a failure to meet the primary endpoint but is still moving forward with new trials given signals of efficacy and safety in an extended study.

You may also be interested in...



Helixmith’s Plasmid DNA Therapeutic Moves Forward With New Formulation

South Korea's Helixmith reaches a milestone with a US FDA nod to use a new in-house developed formulation for its plasmid DNA therapeutic Engensis, said to be more suited to mass production, in its upcoming Phase III trials for diabetic peripheral neuropathy.

Paying For Gene Therapy: Biggest Cost Challenges Two To Three Years Away?

Only about one-quarter of the 40 gene therapies projected to launch by the end of 2025 would have potential US patient populations of more than 50,000. But a handful of treatments could target millions of individuals.

Paying For Gene Therapy: Biggest Cost Challenges Two To Three Years Away?

Only about one-quarter of the 40 gene therapies projected to launch by the end of 2025 would have potential US patient populations of more than 50,000. But a handful of treatments could target millions of individuals.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

SC141675

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel