Dr Reddy's Laboratories Ltd Monday said it has obtained positive results in the phase-IIb study of its oral molecule PPC-06 (formerly referred to as XP23829) in patients with moderate to severe plaque psoriasis.
According to a press release from the city-based drug-maker, the detailed safety and efficacy data from the study would be presented in future dermatology conferences.
Senior vice-president and head, proprietary products business of the company, Anil Namboodiripad said 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 mono methyl fumarate (MMF) for treatment of moderate to severe plaque psoriasis in the US," the official said.
Further clinical development requirements would be discussed with the USFDA to support the approval of this product, he added.
The most common adverse events (AEs) reported were lymphocytopenia, eosinophilia and gastro-intestinal (GI) disorders, such as diarrhoea, 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, chief medical officer of Promius Pharma, the US subsidiary of Dr Reddys.