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Dr. Reddy's Reports Positive Top-Line Data on Psoriasis Drug

Zacks Equity Research

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 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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