1. Scrip
  3. >>Gene Therapies

Helixmith Facing Engensis Challenges After Disappointing First Phase III Data

 
• By Jung Won Shin

Helixmith delays making conclusions on disappointing first top-line data from lead US Phase III study of plasmid DNA therapeutic Engensis, citing unexpected pharmacokinetic results in the placebo and treatment groups. The South Korean biotech vows to improve strategy for upcoming trials, but much may hinge on their success.

Signpost
Helixmith Eyes Strategies For Engensis Trial Success • Source: Shutterstock

Helixmith has found serious flaws in pharmacokinetic data from the first Phase III trial with its lead product Engensis (VM202) and has delayed making conclusions based on what were the first top-line results from a US study.

During a review of the recently completed Phase III study of Engensis versus placebo in 500 patients with painful diabetic peripheral neuropathy (PDPN), the South Korean venture discovered that Engensis...

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

Bluebird, Private Equity Firms Look To Sweeten Buyout Deal

 
• By Alaric DeArment

Shareholders are being offered a flat fee of $5 per share as an alternative to $3 plus a contingent value right, which could be a more attractive option if they want cash up front.

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.

Abeona Sets $3.1m Price For Rare Skin Disorder Gene Therapy

 
• By Joseph Haas

Abeona plans to offer an outcomes-based payment model for Zevaskyn, which likely will see complementary use with Krystal’s Vyjuvek in recessive dystrophic epidermolysis bullosa patients.

Verve Moves Toward Lilly Opt-In For PCSK9 Program With Phase Ib Results

 
• By Alaric DeArment

The company posted positive initial results from the Heart-2 trial in HeFH and CAD, with strong LDL cholesterol lowering and a clean safety profile.

More from Advanced Therapies