View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
March 7, 2022

Recce obtains safety committee advice for Phase I trial of infectious disease asset

The randomised Phase I trial will analyse the safety and pharmacokinetics of R327 across eight dosing cohorts.

Recce Pharmaceuticals has reported that the Independent Safety Committee recommended advancement of the Phase I clinical trial of RECCE 327 (R327).

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

The latest development comes after the committee analysed trial data from ten healthy participants who received intravenous (IV) doses of R327, which showed favourable safety and tolerability.

The committee further recommended progressing the trial to Cohort 4 to analyse a 1,000mg IV dose of R327.

An intravenous and topical treatment, RECCE 327 is being developed to treat serious and possibly serious infections caused by Gram-positive and Gram-negative bacteria including their superbug forms.

The randomised, ascending dose, placebo-controlled, single-dose, parallel, double-blind trial will analyse the safety and pharmacokinetics of R327 in seven to ten healthy participants per dose, across eight dosing cohorts of 50-16,000mg.

It is being carried out at the CMAX clinical trial facility in the Australian city of Adelaide.

Subject recruitment to Cohort 4 commenced with all subjects to be dosed with IV 1,000mg R327 in a week.

Recce noted that the trial is on track to conclude dosing in Phase I trial by the second quarter of this year.

Recce Pharmaceuticals CEO James Graham said: “Recommendation to start IV dosing of Cohort 4 (R327 I.V.; 1,000mg) is a wonderful endorsement for the compelling safety and tolerability profile demonstrated among 10 subjects of Cohort 3.”

The company focuses on developing a new class of synthetic anti-infectives that can tackle the crucial health problems of antibiotic resistant superbugs and emerging viral pathogens across the globe.

Apart from R327, the anti-infective pipeline of Recce comprises two broad-spectrum, synthetic polymer anti-infectives, RECCE 435 and RECCE 529.

RECCE 435 and RECCE 529 are oral therapies intended for bacterial and viral infections, respectively.

Related Companies

Free Case Study
img

Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
Enter your details here to receive your free Case Study.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Clinical Trials Arena