Swedish firm RhoVac has reported that its Phase IIb BRaVac clinical trial of drug candidate, RV001 (onilcamotide), in prostate cancer patients failed to meet the primary endpoint.
In 2019, the company launched this placebo-controlled trial of RV001 in prostate cancer patients with biochemical recurrence following curative intent therapy.
The goal of the trial was to demonstrate that onilcamotide could substantially avert or delay the progression of the disease in participants, for which there exists no standard therapy currently.
Interim safety reviews were carried out with no unanticipated adverse events reported and the end trial data validate the expected safety of RV001.
On efficacy, the trial failed to meet the primary endpoint to show the superiority of the drug versus placebo in lowering the risk of disease progression.
Either a doubling of PSA, clinical recurrence or mortality were considered as progression.
Initial findings did not show any substantial data on enhanced outcomes for the trial subjects, the company noted.
The latest data is despite the previously reported positive Phase I/II data linked to the drug candidate.
RhoVac will carry out an in-depth review of the findings, and a clear plan for moving forward will be disclosed by the end of next month.
Parallelly, the company will execute a cost reduction contingency plan.
The primary outcome assessment indicates that a licence or acquisition deal based on the trial findings alone is unlikely.
RhoVac CEO Anders Månsson said: “Even though we know that benchmarks state that the probability of success for a phase II project in oncology is less than 50% and that clinical development is always a calculated risk, we are surprised and deeply saddened to find that BRaVac failed to meet its primary endpoint.
“We will immediately minimise expenditure, while further assessing the study data, with the aim of coming up with firm recommendations on how to proceed, and to communicate this end June.”