Mutual Funds Commodities Research Tax Planning IPO Our Team Contact Us    
Google
Web www.equitybulls.com
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 feedback@equitybulls.com





Other Headlines:

PNB board approves raising Rs. 1500 crore through Basel III compliant Tier II bonds

BEML donates for cyclone 'Fani' relief work, Odisha

TAAL Enterprises Ltd calls for board meeting on June 24, 2019

Newgen Makes its OmniFlow iBPS Platform More Intelligent with Process Insights

HDFC Limited to acquire Apollo Hospitals Group's shares in Apollo Munich and to merge with HDFC ERGO

TCS Retains Position as America's Most Community-Minded Information Technology Company

Bombay Cycle & Motor Agency Ltd Board to consider Bonus Issue on June 22, 2019

IndusInd Bank Ltd announces record date for issue of shares to BFIL shareholders

Brickwork reaffirms rating of Parsvnath Rail Land Project Pvt Ltd

Adani Green Energy Ltd arm receives LOAs for 600 MW hybrid projects

TCS Named 2018 Top Supplier of the year by QIAGEN

International Paper APPM Ltd announces annual outage from July 29, 2019 to Aug 28, 2019

Rajesh Exports bags new export order worth Rs. 942 crores from Germany, Europe

Indostar Capital Finance Limited and ICICI Bank Limited partner to finance Commercial Vehicles

BHEL successfully commissions Chhukha Unit-1 in Bhutan

Asian Oilfield Services receives orders of $37 mn

GAIL India Ltd fixes July 10, 2019 as record date for bonus issue

Blue Star Ltd receives single largest order from Mumbai Metro

Jubilant FoodWorks Ltd announces change in directorate

L&T Construction awarded contract for water supply and distribution in Sri Lanka

Polyplex Corporation Ltd's subsidiary to set up 60000 TPA BOPP film line project

JV Partners announce Final Investment Decision for initial two LNG train Project Development

Mahindra announces price increase for personal range of vehicles from July 1, 2019

Lawreshwar Polymers Ltd proposes name change

Thomas Cook India releases its Summer Report 2019

Asian Granito India Ltd inaugurates its largest - 25,000 sq feet tiles and Sanitaryware display showroom in Himmatnagar

ONGC Videsh Ltd, JV partners announce Final Investment Decision for initial two LNG train Project Development

Inspirisys Solutions Ltd to allot 56,25,000 shares to CAC Holdings Corporation at Rs. 54.30

HCL Technologies selected by Cricket Australia as Digital Technology Partner

Cognizant to acquire Zenith Technologies, a Leader in Life Sciences Manufacturing Technology Services

IndiGo awarded 'Best Low-Cost Airline in Central Asia/India' by Skytrax tenth year in a row

Chambal Fertilisers and Chemicals Limited updates on credit rating of Commercial Paper

NLC India Ltd commissions 100 MW solar PV power plant

RMG Alloy Steel Limited board approves issue of securities

Dabur India Ltd board to consider Q1 results on July 19, 2019

Sportking India Ltd updates on credit rating

Sundaram Multi Pap Ltd receives BB+ rating from Brickwork

Canara Bank to initiate process to sell stake in Can Fin Homes Ltd

Coromandel Engineering Company Limited to issue CNPRPS on private placement basis

Wintac Ltd board to re-initiate delisting process proposed by Veego Pharma LLC

Adlabs Entertainment Ltd announces resignation of Ms. Meghna Ghai Puri

TCS Named a Leader in Next-Gen Testing Services by NelsonHall

Trent Ltd to raise Rs. 950 crores from Tata Sons Pvt Ltd

Canara Bank to raise Rs. 6000 crores through equity issue

Infosys recognized as winner for 2019 Microsoft Global Alliance SI Partner of the Year

HCL Technologies celebrates 20 years of Innovation in Australia and New Zealand

WABAG secures One City One Operator contracts in Uttar Pradesh worth INR 1,477 Crore

Hexaware Ranks No. 1 Among the Top Service Providers in Overall Customer Satisfaction in Whitelane's IT Sourcing Study

KNR Srirangam Infra Pvt Ltd receives appointed date from NHAI

David Hennah quits Finastra to join Intellect Global Transaction Banking







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

disclaimer copyright © 2005 - 2019