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Dr. Reddy’s Laboratories Limited Through Its Wholly Owned Subsidiary, Dr. Reddy’s Laboratories SA, Announces Positive Topline Results from Phase 2b Study of PPC-06 in Patients with Moderate to Severe Plaque Psoriasis

June 10, 2019 Off By BusinessWire

HYDERABAD, India–(BUSINESS WIRE)–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 0 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
topline 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 U.S. Further
clinical development requirements will be discussed with the US FDA to
support the approval of this product,” said Anil Namboodiripad PhD.,
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 U.S. Patients had stable, moderate to
severe plaque psoriasis for at least 6 months, with PASI (Psoriasis Area
and Severity Index) scores ≥12, IGA (5-point Investigator’s Global
Assessment) scores ≥3, and psoriasis lesions involving 10% or more of
the patient’s Body Surface Area (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 of 0 or1
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 0 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.

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124,
NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company,
committed to providing affordable and innovative medicines for healthier
lives. Through its three businesses – Pharmaceutical Services & Active
Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s
offers a portfolio of products and services including APIs, custom
pharmaceutical services, generics, biosimilars and differentiated
formulations. Our major therapeutic areas of focus are gastrointestinal,
cardiovascular, diabetology, oncology, pain management and dermatology.
Dr. Reddy’s operates in markets across the globe. Our major markets
include – USA, India, Russia & CIS countries, and Europe. For more
information, log on to: www.drreddys.com

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