Dr. Reddy’s Laboratories Ltd. RDY announced positive top-line results from the phase IIb study on 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 of PASI-75 (proportion of treated subjects achieving a 75% reduction in their PASI score over baseline) and IGA scores of 0 or 1, with at least a 2-point reduction from baseline after 24 weeks of oral treatment.
PPC-06 is an extended release formulation of a fumaric acid ester (FAE), in-licensed from Xenoport for further development to treat moderate-to-severe plaque psoriasis.
Shares of the company have increased 23.2% in the past year against the industry’s decline of 38.2%.
The study was conducted to evaluate the tolerability, safety and efficacy of three doses of PPC-06 over 24 weeks. It showed that patients had stable, moderate-to-severe plaque psoriasis for at least 6 months, with Psoriasis Area and Severity Index (PASI) scores ≥12, 5-point Investigator’s Global Assessment (IGA) scores ≥3, and psoriasis lesions involving 10% or more of the patient’s Body Surface Area (BSA) at study baseline.
Per Dr. Reddy’s, given the positive clinical data from this study,PPC-06 may become the first approved oral prodrug of Monomethyl Fumarate (MMF) for the treatment of moderate-to-severe plaque psoriasis in the United States.
Psoriasis has a huge unmet medical need and several companies are developing drugs to treat this disease. Another company, Athenex, Inc.ATNX along with Taiwan’s PharmaEssentia Corp. announced positive preliminary data from phase I study on its pipeline candidate KX2-391 (tirbanibulin) ointment. Positive early clinical signals were observed in a small cohort of patients with psoriasis treated with the ointment in a phase I study.
We remind investors that, Novartis NVS also has a psoriasis drug, Cosentyx in its portfolio which is one of its key drugs marketed in the United States.
Dr. Reddy's Laboratories Ltd. Price
Dr. Reddy's Laboratories Ltd price | Dr. Reddy's Laboratories Ltd Quote
Zacks Rank, Stock to Consider
Dr. Reddy’s currently carries a Zacks Rank #5 (Strong Sell).
A better-ranked stock worth considering is Anika Therapeutics Inc. ANIK carrying a Zacks Rank#1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have moved up from $1.22 to $1.28 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
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