Blood Clot Treatment Fast-tracked By FDA
SEPTEMBER 27, 2018
Cecilia Pessoa Gingerich
Erik Tucker, PhDThe US Food and Drug Administration (FDA) has granted a Fast Track designation for proCase (E-WE thrombin, AB002), an enzyme that is intended to reverse blood clot formation. Unlike other treatments for blood clots, Aronora Inc.’s proCase does not increase the risk of bleeding.
"We are incredibly excited about this FDA Fast Track designation, which will enable us to accelerate clinical development of proCase for patients with life-threatening blood clots, including those suffering from stroke and heart attack," said Erik Tucker, PhD, Co-founder and Chief Operating Officer of Aronora.
The FDA grants Fast Track designation to drugs that are being developed to treat a serious or life-threatening disease or condition, or when the drug fills an unmet medical need. Conditions such as AIDS, Alzheimer’s disease, heart failure, epilepsy, depression, and diabetes, among others, are considered serious conditions by the FDA.
"The last new clot-busting drug, tissue-plasminogen activator (tPA), was first approved by the FDA in 1987,” added Tucker. “However, tPA can significantly increase the risk of bleeding, so it is used only in a very small percentage of blood clot victims.”
The proCase enzyme works by targeting blood clots and enhancing the body’s antithrombotic, thrombolytic, and cytoprotective mechanisms. Aronora has just begun clinical trials for proCase with a phase 1 trial currently recruiting participants.
The randomized, placebo-controlled study is expected to include 21 healthy adult participants. The first primary outcome measure is the number of participants with treatment-emergent adverse events. The estimated completion date for this trial is November 2018.
With Fast Track designation, proCase may qualify for more frequent meetings and written communications from the FDA, and for Accelerated Approval designation.
“It's time for a new generation of safer emergency blood clot treatments, and we look forward to working closely with the FDA to develop this truly revolutionary drug candidate," said Tucker.