View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
  2. Company News
June 8, 2018updated 13 Jul 2022 9:14am

Spyryx reports positive data in first cohort of HOPE-1 trial

Spyryx Biosciences has reported positive results from the first cohort of Hydration for Optimal Pulmonary Effectiveness (HOPE-1) Phase ll clinical trial of SPX-101 to treat patients with cystic fibrosis (CF).

Spyryx Biosciences has reported positive results from the first cohort of Hydration for Optimal Pulmonary Effectiveness (HOPE-1) Phase ll clinical trial of SPX-101 to treat patients with cystic fibrosis (CF).

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 exploratory, randomised, placebo-controlled, 28-day trial has so far enrolled 46 adult CF patients who are independent of CFTR mutation type. The trial aims to enrol a total of 90 patients.

The trial’s first cohort compared a high dose (120mg), a low dose (60mg) and placebo in patients with baseline percent predicted forced expiratory volume in 1 second (ppFEV1) of 40%-80%.

During the trial, SPX-101 was given by nebulisation through a new, silent, rapid and portable nebuliser, ENaC, while ppFEV1 was measured at days seven, 14 and 28.

The cohort’s primary efficacy endpoint was the absolute change from baseline in ppFEV1 after 28 days.

The new results have shown that at day 28, a dose-related benefit was witnessed with the high dose showing a placebo adjusted increase of 5.2% in ppFEV1.

“This data is also very promising in terms of respiratory benefit gained from ENaC inhibition.”

It was also found that with the high dose, ppFEV1 separation from placebo was achieved by day seven and it continued through the treatment period.

In the subgroup of moderate patients with baseline pp FEV1, less than 55% of the high dose response at day 28 was observed at 8.3%. SPX-101 was also reported to be safe and well tolerated with the most common adverse events being cough and sputum production.

HOPE-1 principal investigator Isabelle Fajac said: “There is urgent need for an effective and safe treatment to promote airway clearance for all patients with CF, regardless of their genetic mutation.

“The data shows that with this novel mechanism – internalisation of ENaC – it is possible to inhibit ENaC in the airways without impacting potassium concentrations in the blood, and this has been a goal in research for the past 30 years.

“This data is also very promising in terms of respiratory benefit gained from ENaC inhibition.”

Spyryx plans to complete the Phase ll trial soon and start preparations for the Phase lll trial of SPX-101 for CF next year.

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