Indications

Indications

Paranta Biosciences is developing a potentially transformative first-in-class biotherapeutic based on PB01, a unique form of recombinant human follistatin for the prevention of delayed graft function during kidney transplantation and other forms of acute kidney injury.

Delayed Graft Function

Acute kidney injury occurs with kidney transplantation and often progresses to the clinical diagnosis of delayed graft function.

Delayed graft function (DGF) is defined as failure of the renal transplant to function immediately, with the transplant recipient requiring dialysis within the first week post-transplantation. It is a form of acute renal failure which can result in graft failure and acute organ rejection.  In addition, patients that experience DGF have prolonged hospitalization, increased risk of cardiovascular events and overall reduced survival.

DGF is more prevalent in kidneys from deceased donors (25-50%) than living donors (4%).  The highest incidence of DGF is from 'expanded criteria' donors i.e. older, presence of comorbidities and/or donation after cardiac death.  With 70% kidney transplants from deceased donors and ~17% from 'expanded criteria' donors, the prevalence of kidney DGF is increasing. 

The transplantation process involves interruption of blood supply (ischemia) during removal and storage of the kidney from the donor followed by restoration of blood supply (reperfusion) during transplantation of the kidney into the recipient.  This process results in ischemia-reperfusion injury (IRI) which can manifest into DGF.

Research performed by Paranta and other investigators indicate that the administration of PB01 reduces IRI-induced inflammation, protects against oxidative stress and promotes growth of kidney tubule cells. Therefore PB01 holds great promise for preventing DGF by modulating many of the contributing pathways which lead to DGF post renal transplant.

  • >100,000

    People in US waiting for kidney transplant

  • None

    Currently no approved therapies for DGF

  • $600+ Million

    Est. size of kidney DGF opportunity

  • ~50%

    DGF prolongs hospitalization by ~50%

  • 11.4%

    DGF reduces survival probability up to 11.4%

Oncology

NSCLC accounts for >85% of all lung cancers. Globally, 1.5M people are diagnosed with NSCLC annually. Long term outcomes are very poor for patients with advanced disease, with only approximately 5% surviving 5 years.

PB01 in vivo studies have shown that parenterally administered PB01 enhances the sensitivity of resistant NSCLC cells to chemotherapy agents, and also reduces platinum-based nephrotoxicity. PB01's activity in other cancer cell lines is currently underway.

Acute Kidney Injury

Targeting DGF is a step into the acute kidney injury (AKI) market.  AKI is defined as a rapid decline in renal function that occurs within hours or a few days.  There are multiple causes of AKI including platinum-based chemotherapies and certain other drugs, sepsis, and major cardiovascular surgery. The rate of AKI during hospitalization in the US is estimated to be 2-5% and up to 67% for all intensive care unit (ICU) patients.  AKI is associated with up to 12 times increased likelihood of in-hospital death and contributes to the development of chronic kidney disease and end-stage renal failure.

 

  • $ multi billion

    Estimated size of the AKI opportunity

  • 1 in 5 people

    Experienced AKI worldwide

  • None

    No effective therapies on the market

  • 12x

    AKI increases likelihood of in-hospital death by 12-fold