Principia updates anticipated final result from PRN1008 trial
Category: #health  By Pankaj Singh  Date: 2019-12-31
  • share
  • Twitter
  • Facebook
  • LinkedIn

Principia updates anticipated final result from PRN1008 trial

Principia Biopharma Inc. recently updated about the anticipated timings for the final result from the ongoing trial of PRN1008 data in patients suffering from pemphigus, along with CRR (complete response rates) from its Phase II Part B trial (open-label).

For the record, Principia Biopharma is a late-stage biopharmaceutical company focused upon developing transformative oral therapies for patients with major unmet medical needs for immune-mediated diseases.

Dolca Thomas, MD and Chief Medical Officer of Principia Biopharma was reportedly quoted saying that the company is pleased to witness the interest in the Phase 3 PEGASUS trial and through the hard work of its study coordinators, investigators and clinical team, the enrollment timelines have speeded up. The final data from the trial which was supposed to be completed in the first half of 2022 will now be updated by the second half of 2021.

Thomas added saying that the company is exhilarated to witness a 40% CRR in the Phase 2 Part B trial (six patients) in spite of most patients being treated initially at a sub-therapeutic 400 mg daily dose.

Among the 15 patients which were dosed in Part B of the Phase 2 clinical trial, 60% (nine) of them achieved the primary endpoint of CDA (control of disease activity) by week 4 on low dose corticosteroids, which was equal to or less than 0.5 mg/kg per day.

12 out of 15 patients, equivalent to 80%, achieved control of disease activity by 12th week. 9 of the 15 patients (60%) have achieved a PDAI score of 1 or 0 (PDAI scoring system indicates disease severity). Safety and efficacy of PRN1008 turned out to be consistent with Phase 2 Part A trial and was also well-tolerated in Part B with no treatment-related serious AE (adverse event) reported. At an upcoming medical conference, final data from the Phase 2 Part B trial will be submitted for presentation.
 

Source Credit: https://ir.principiabio.com/news-releases/news-release-details/principia-updates-prn1008-pemphigus-clinical-program

  • share
  • Twitter
  • Facebook
  • LinkedIn


About Author

Pankaj Singh    

Pankaj Singh

With an experience as an insurance underwriter and a freelance writer under his belt, Pankaj Singh boasts of quite some expertise in the field of content creation. A qualified Post Graduate in Management, Pankaj has also completed a detailed course in Digital Marketin...

Read More

More News By Pankaj Singh

Hyundai supports Teslas appeal for lowering EV import duties in India
Hyundai supports Teslas appeal for lowering EV import duties in India
By Pankaj Singh

India's second-largest automaker, Hyundai Motor India has recently backed Tesla's proposal for lower import duties on electric vehicles. In a statement, Hyundai said that any drop in import duties will be a big help to automakers to generate ...

Unacademy takes over live game streaming platform Rheo TV
Unacademy takes over live game streaming platform Rheo TV
By Pankaj Singh

Unacademy, an Indian educational technology company, has recently announced the purchase of Rheo TV, a live game streaming platform focused on making professional game streaming a mainstream career choice in India. Launched in August 2019, Rheo...

Byju's acquires Epic to strengthen footprint in North America
Byju's acquires Epic to strengthen footprint in North America
By Pankaj Singh

Byju's, a major Ed-tech company based in India, has reportedly taken over Epic, a US-based digital reading platform for kids, in a $500 million deal, with plans to enter the lucrative international market. The acquisition comes over three months...