AzurRx doses first patients in Phase II OPTION study for EPI therapy
Category: #health  By Mateen Dalal  Date: 2019-02-21
  • share
  • Twitter
  • Facebook
  • LinkedIn

AzurRx doses first patients in Phase II OPTION study for EPI therapy

AzurRx BioPharma, Inc. has recently informed that the company has dosed the first patients in its Phase II OPTION clinical study aimed at investigating MS1819-SD in cystic fibrosis (CF) patients who experience exocrine pancreatic insufficiency (EPI).

Supposedly, the multi-center Phase II trial has been designed to explore the efficacy, tolerability and safety of MS1819-SD, comparing it directly with the existing porcine enzyme replacement therapy (PERT) care standard. Around 30 CF patients are planned to be enrolled in the study, with top-line results being expected in mid-2019.

According to AzurRx BioPharma, the OPTION study primarily involves a six week long non-inferiority and coefficient of fat absorption (CFA) evaluation to compare MS1819-SD with the standard of care PERT in patients with EPI resulting from cystic fibrosis. Its cross-over study design would be able to leverage input from the CF community as well as from the U.S. Food and Drug Administration. The nearly 30 patients to be enrolled in the trial would be aged 18 years or above, the company stated.

Michael W. Konstan, M.D., Case Western Reserve University School of Medicine’s Professor of Population & Quantitative Health Sciences as well as Pediatrics, who is also the Vice Dean for its Translational Research, mentioned that for a long time the CF community has identified the unmet need regarding a non-porcine based pancreatic enzyme option, as an alternative to current treatments of EPI in CF patients.

The company said that in a recently confirmed Phase II trial in the chronic pancreatitis setting, a good tolerability and favorable safety profile was exhibited by MS1819-SD. Besides, the highest studied dose had shown a statistically significant improvement in CFA of 21.8%.

AzurRx’s CEO, Thijs Spoor commented that dosing the first patients in the company’s OPTION trial of MS1819-SD in CF patients is representative of the firm’s remarkable achievement, demonstrating that it is on track to finish the Phase 2 study by mid-2019, the previously informed timeline.

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Mateen Dalal    

Mateen Dalal

Mateen has completed his Bachelor’s degree in electronics and telecommunication engineering, post which he lent his proficiency to the industry, working as a quality and test engineer. Drawn intricately toward the field of content creation however, Mateen soon switc...

Read More

More News By Mateen Dalal

UAE extends travel ban for Indians amid strict COVID-19 guidelines
UAE extends travel ban for Indians amid strict COVID-19 guidelines
By Mateen Dalal

United Arab Emirates (UAE) has reportedly extended travel ban for individuals travelling from India and several other south Asian countries on the pretext of COVID-19 guidelines. As reported by Etihad Airlines, the ban will be followed till 31st July...

Adevinta Ventures backs Lovys's Series A follow-on investment round
Adevinta Ventures backs Lovys's Series A follow-on investment round
By Mateen Dalal

Adevinta Ventures, an investment arm of Adevinta, has announced its investment in French insurance service provider ‘Lovys’, marking as its first investment in France in the Fintech and Insurtech sector. With this investment, Adevinta Ve...

Indian EV startup eBikeGo expands fleet to 2,100, hires 70 employees
Indian EV startup eBikeGo expands fleet to 2,100, hires 70 employees
By Mateen Dalal

The company is aiming for achieving a 2% share in the Indian electric two-wheeler market, with plans to deploy 200,000 e-scooters across 100 cities eBikeGo, an electric vehicle startup, has recently revealed that it has increased its fleet of electr...