Retrophin announces positive Phase II results, Shkreli claims credit
pharmafile | September 8, 2016 | News story | Research and Development | Phase II, Retrophin, Shkreli, rare kidney disease
Retrophin has announced positive top-line results for trial drug sparsentan in Phase II to treat a rare kidney disorder with no approved treatment, but former-CEO and self-anointed “pharma bro” Martin Shkreli weighed in to claim a degree of credit for the trial’s success.
Sparsentan is under investigation for the treatment of focal segmental glomerulosclerosis (FSGS). The disease affects up to 40,000 people in the US, with a similar prevalence in Europe, and is defined by progressive scarring of the kidney and often leads to end-stage renal disease. The drug works through a dual mechanism action, combining angiotensin receptor blockade with endothelin receptor type A blockade.
In the Phase II DUET study, sparsentan achieved statistical significance in the primary efficacy endpoint, demonstrating a greater than two-fold reduction of proteinuria, or abnormal quantities of protein in urine, compared to Sanofi’s ibresartan.
Stephen Aselage, CEO at Retrophin, says: “We are very pleased with the robust to-line results from DUET, which suggests sparsentan could be a significant advancement in the treatment of FSGS. FSGS patients today face poor outcomes with limited medical options; we look forward to working with the FDA to find the most expeditious path forward that would deliver the first approved pharmacologic treatment to the FSGS community.”
Never one to miss an opportunity to reappear in the limelight, disgraced ex-Retrophin CEO Martin Shkreli took to twitter to highlight the drug’s Phase II success. He declared that he was available to speak on “[his] first drug being successful for a lethal rare disease.” He then went on to say that “[he named it spar-sentan because it “spar”es endothelian B receptor binding. Sentan is the endothelian suffix.” He followed these sentiments with a personal attack on Captain America actor, Chris Evans.
Shkreli did leave the company in 2014, so obviously does deserve a degree of credit for bringing the drug into clinical development. Last year, Retrophin announced that it was suing the former CEO for $65 million.
Retrophin’s stock soared upon the announcement, with shares up almost 30% to $20.81.
Sean Murray
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