Mutual Funds Commodities Research Tax Planning IPO Our Team Contact Us    
Stock Report

| More

Dr. Reddy's Laboratories SA, announces positive topline results from Phase 2b study of PPC-06 in patients with moderate to severe plaque psoriasis

Posted On: 2019-06-10 13:22:53

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as "Dr. Reddy's") announced positive topline results from its Phase 2b study of PPC-06 (formerly referred to as XP23829) in patients with moderate to severe plaque psoriasis. In the study, PPC-06 met both co-primary endpoints i.e. PASI- 75 and IGA scores of O or 1 with at least a 2-point reduction from baseline, after 24 weeks of oral treatment. The detailed safety and efficacy data from the study will be presented in future dermatology conferences.

"PPC-06 is an oral molecule with a novel mechanism of action that has the potential to address unmet medical needs of psoriasis patients. The top line data we are reporting today support our belief that PPC-06 may become the first approved oral prodrug of Monomethyl Fumarate (MMF) for treatment of moderate to severe plaque psoriasis in the US. Further clinical development requirements will be discussed with the US FDA to support the approval of this product", said Anil Namboodiripad PWJ., Senior Vice President and Head, Proprietary Products Business.

PPC-06 is an extended release formulation of a fumaric acid ester (FAE), in-licensed from Xenoport, Inc. for further development to treat moderate to severe plaque psoriasis. A Phase 2b clinical study was conducted to evaluate the tolerability, safety and efficacy of three doses of PPC-06 over 24 weeks. This was a randomized, double blind, placebo-controlled, dose-finding multicenter efficacy and safety study conducted at 76 sites in the US. Patients had stable, moderate to severe plaque psoriasis for at least 6 months, with PASI (Psoriasis Area and Severity Index) scores 2:12, IGA (5-point Investigator's Global Assessment) scores 2:3, and psoriasis lesions involving 10% or more of the patient's Body Surface žea (BSA) at study baseline. A total of 426 patients were randomized in a 1: 1: 1: 1 ratio into 4 treatment arms: 400 mg QD, 400 mg BID, 600 mg BID, and placebo. The co-primary end points of the study were PASI-75 (i.e. proportion of treated subjects achieving a 75% reduction in their PASI score over baseline) and IGA score ofO orl at week 24.

At week 24 analysis, PASI-75 was achieved by 44.3%, 47.2% and 39.7% patients in PPC-06 600 mg BID, 400 mg BID and 400 mg QD treatment groups respectively, against 20% of patients in the placebo group (p<0.05). Additionally 44.4%, 41.4% and 35.7% of patients in the PPC 06 600 mg BID and 400 mg BID and 400 mg QD groups, respectively, achieved an IGA score of O or 1 (IGA Clear) at week 24 against 22% of patients in the placebo group (p<0.05).

The most common adverse events (AE's) reported were lymphocytopenia, eosinophilia and gastro-intestinal (GI) disorders, such as diarrhea, nausea, abdominal pain and vomiting.

"Given the positive clinical data in this study, PPC-06 may have a potential to serve as an important therapeutic option for psoriasis patients in a market with limited oral treatments. We thank all the patients, investigators and study staff whose ongoing participation helped us achieve this target." said Sagar Munjal, MD, MS, Chief Medical Officer Promius Pharma/VP Clinical Development & Medical Affairs.

Shares of DR.REDDY'S LABORATORIES LTD. was last trading in BSE at Rs.2582.75 as compared to the previous close of Rs. 2657.35. The total number of shares traded during the day was 41778 in over 3107 trades.

The stock hit an intraday high of Rs. 2662 and intraday low of 2559.65. The net turnover during the day was Rs. 108104628.

Source: Equity Bulls

Click here to send ur comments or to

Other Headlines:

Spirit of Wipro Run Brings Together Participants from 110 Cities Across 34 Nations

Cigniti Technologies Ltd bags 'Corporate Leader of the Year' award at I-ACE awards

Thyrocare Technologies Ltd updates on stake sale in Nueclear Healthcare Ltd

Thomas Cook India, a separate entity and Thomas Cook UK has no stake in India Company

Shri P Jayarama Bhat elected as the Chairman of the governing board of SIBSTC, Bengaluru

Bricwork revises credit rating of Edelweiss Financial Services' NCDs

Capital India Finance Ltd acquires stae in Rapipay Fintech Holding Pvt Ltd

Ravindra Energy Ltd bags contract

Bank of Maharashtra and Paisalo Digital Limited sign Co-Origination of Loan Agreement

Shilpa Medicare Ltd gets shareholders nod for final dividend

Fredun Pharmaceuticals Ltd receives award from Saraswat Co-Operative Bank Ltd

Jump Networks Ltd inks agreement to become the principal sponsor of The Forca Goa Foundation

Sundaram-Clayton Ltd board to approve quarterly results on Oct 18, 2019

Filatex India Ltd updates on expansion project


Biocon Ltd updates on pre-approval inspection by US FDA

Dhunseri Ventures Limited updates on ratings

Wanbury Ltd approves debt settlement and fund raising through brand sale

ICRA updates on Canara Bank's Basel III compliant Tier II bonds

Commercial Engineers & Body Builders Co Ltd to form JV

GOCL Corporation Ltd board to consider special interim dividend on Sep 27, 2019

Adani Group recognised as the best coal service provider at Mjunction awards

W S Industries India Ltd board approves roll over of preference shares

TVS Motor Company Ltd board to announce Q2, H1 results on Oct 17, 2019

Asian Granito in Fortune India's List as one of The Next Fortune 500 companies

Pantaloons Celebrates the Pujo Rockstars this Pujo with its new campaign

Indian Overseas Bank celebrates Hindi Month - 2019

Alkem Laboratories Ltd acquires undertaking from subsidiary

Sakthi Sugars Ltd agrees for OTS with Bank of India

Pidilite Industries Ltd forms subsidiary

Corporate Tax reduction - Mr. Kamlesh Patel, Chairman and Managing Director - Asian Granito India Ltd

Seamec Ltd announces extension of long term charter for SEAMEC II with HAL Offshore Ltd

Nippon Express to Acquire 22% Stake in Future Supply Chain Solutions Ltd

Hexaware's Salesforce practice has been awarded Gold Consulting Partner status

Lupin receives sANDA approval from U.S. FDA for Levothyroxine Sodium Tablets USP to be considered AB rated to Reference Listed Drug, UNITHROID®

USFDA approval for Unichem Laboratories Ltd's plant at Kolhapur

Zensar Recognized in the 2019 Gartner Magic Quadrant for Data Center Outsourcing and Hybrid Infrastructure Managed Services, North America

Asian Paints launches 'AP Homes' in Bengaluru, its state-of-the-art multi-category décor showroom

Allahabad Bank Introduces External Benchmark Linked Loans under Retail and Micro & Small Enterprises

IndiGo inaugurates flights between India and Myanmar

Strides Board approves incremental investments in Stelis

Himatsingka Seide Ltd board approves investment of Rs. 17.34 crore in wind power SPVs

AXIS Bank Ltd board to consider Q2 results on Oct 21, 2019

Bingo! Pujo Tadka enlivens the festive spirit of Durga Pujo

Just Launched: Official App for TCS Lidingöloppet 2019 Packed with Exciting New Features

Raksha Mantri inaugurates Engineers Conclave (2019), Product Development & Innovation Centre of BEL

Redington offering the latest products from Apple, including iPhone 11 Pro and iPhone 11 Pro Max

Dilip Buildcon Ltd completes road project in Punjab

Anuh Pharma Ltd successfully completes USFDA inspection

Bajaj Electricals Limited receives 2019 ASCM Corporate Award of Excellence for Advance Supply Chain Industry

Website Created & Maintained by : Chennai Scripts
West Mambalam, Chennai - 600 033,
Tamil Nadu, India

disclaimer copyright © 2005 - 2019