News round-up for 6-10 March by DDW Digital Content Editor Diana Spencer.
Perhaps most interestingly this week, after previous caution over in vivo gene therapy trials, the FDA has given the go ahead to Intellia Therapeutics to study NTLA-2002 in hereditary angioedema (HAE).
There have been several other announcements related to clinical trials in the last few days, including positive data from trials in severe influenza and biliary tract cancer, the launch of a study into an ADC treatment for solid tumours, and a new research partnership with the mission to improve clinical trial design.
The top stories:
FDA clears in vivo gene editing therapy for trials in US
The US Food and Drug Administration (FDA) has cleared Intellia Therapeutics’ Investigational New Drug (IND) application for NTLA-2002 for the treatment of hereditary angioedema (HAE).
Research organisations partner to transform clinical trials
The Duke Clinical Research Institute (DCRI) and Protas, led by Oxford University clinical trialist Professor Sir Martin Landray, will collaborate to develop new approaches to large randomised clinical trials.
New results for severe influenza and inflammatory conditions
Poolbeg Pharma has announced data from the bacterial lipopolysaccharide (‘LPS’) human challenge trial for POLB 001, a viral strain agnostic, small molecule immunomodulator.
Company launches ADC Phase I trial in solid tumours
Dosing has begun in a Phase I clinical study evaluating BAT8008, an antibody-drug conjugate (ADC) that targets Trop2.
Topline data from Phase II monotherapy module
Redx has shared topline monotherapy data from the biliary tract cancer (BTC) module of the RXC004 PORCUPINE2 Phase II clinical trial programme.