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Patients suffering from Psoriasis have some good news. Researchers at Dr Reddy’s Laboratories announced that its candidate drug (PPC-06) has emerged as a therapeutic option for treating the medical condition.
Psoriasis is a chronic skin condition caused by an over active immune system. The symptoms include inflammation, red patches of skin, flaking etc. The treatment routines followed are creams, oral medicines and light therapy.
In the Phase 2b studies, the drug provided positive clinical data in patients with moderate to severe plaque psoriasis. It met the prescribed treatment standards after 24 weeks of oral treatment. “Given the market with limited oral treatments, the development bodes well” said Sagar Munjal, Chief Medical Officer, Promius Pharma.
Promius Pharma is a wholly owned subsidiary of the Hyderabad-based Dr Reddy’s Laboratories. The company plans to present the detailed safety and efficacy data from the trials 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 US. Further clinical development requirements will be discussed with the US FDA to support the approval of this product", said Anil Namboodiripad, 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. The 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 multi-centre efficacy and safety study conducted at 76 sites in the United States (US). Patients had stable, moderate to severe plaque psoriasis for at least 6 months. A total of 426 participated in the study for 24 weeks.
The most common adverse events (AE’s) reported were lymphocytopenia, eosinophilia and gastro-intestinal (GI) disorders, such as diarrhoea, nausea, abdominal pain and vomiting.
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