Proteon Therapeutics Inc. (NASDAQ: PRTO) shares were absolutely crushed on Thursday after the firm announced results from its late-stage trial in patients with chronic kidney disease (CKD). Specifically, the Phase 3 results of vonapanitase came from the Patency-2 trial in patients with CKD undergoing creation of a radiocephalic fistula for hemodialysis.
Unfortunately, the study did not meet its co-primary endpoints of fistula use for hemodialysis and secondary patency. The adverse events with vonapanitase were similar to placebo and consistent with previous clinical trials.
As one of the co-primary endpoints, 69.7 % of vonapanitase-treated patients achieved use of the fistula for hemodialysis, compared to 65.1% of placebo-treated patients, a result that is not statistically significant. Separately, at the end of one year, 78% of vonapanitase-treated patients maintained secondary patency, compared to 76% of placebo-treated patients. Again, this was not statistically significant.
Management estimates that Proteon will have at March 31, 2019, cash, cash equivalents and available-for-sale investments of $16.5 million.
Timothy Noyes, president and CEO of Proteon, commented:
We believe this trial was well conducted and are surprised and disappointed by these results. We want to thank the clinical investigators and patients who volunteered to participate in this important clinical program. In the coming weeks and months, the Company intends to review the full data set from PATENCY-2 and evaluate our strategic options.
Shares of Proteon were last seen down about 85% at $0.54, in a 52-week range of $0.53 to $3.94. The consensus price target is $5.67.