STOCKHOLM, November 8, 2018 — PledPharma AB (publ), a Swedish pharmaceutical developer, today announced that the first patient has been enrolled in the company’s global Phase III program with the company’s drug candidate PledOx®. An important and historical step for PledPharma has thus been taken.
The global Phase-III program for PledOx® consists of two double-blind, randomized, placebo-controlled studies - POLAR-M and POLAR-A and will include a total of 700 patients in the US, Europe and Asia. The company assesses the recruitment rate to 10-12 months based on updated feasibility studies with participating sites.
The POLAR-M study will include 420 patients undergoing chemotherapy treatment for metastatic colorectal cancer and is conducted in Europe, Asia and the United States. The first patient has now been enrolled in the United States.
The POLAR-A study comprises 280 patients undergoing adjuvant chemotherapy for colorectal cancer and will be conducted in Europe and Asia. The first patient is expected to be enrolled during current quarter.
"It is with great satisfaction that we reach this important and historic milestone, having the first patient included in our global Phase III program for PledOx®. Pledpharma has for many years been working intensively to develop the first in class drug against chemotherapy induced nerve damages that affect many colorectal cancer patients. To have reached this milestone as a small pharmaceutical development company is rewarding and recognition of the potential of our project. We have taken a major step towards offering patients treatment with our drug candidate." says Nicklas Westerholm, CEO, PledPharma AB.
Today's standard treatment for colorectal cancer is based on the chemotherapy agent oxaliplatin, which is associated with dose-limiting and potentially debilitating nerve damages. Between 40 and 60 percent of the patients suffer from such nerve damages during and after treatment, of which 20 to 30 percentage points are affected by chronic damages. Currently there are no approved preventive or mitigating treatments available.
For more information, please contact:
Nicklas Westerholm, CEO, phone: +46 73 354 20 62
Yilmaz Mahshid, CFO, phone: +46 72 231 68 00
PledOx® is a “first in class” drug candidate developed to provide patients, that are treated adjuvantly or for metastatic colorectal cancer, prevention against the nerve damage that can occur in conjunction with chemotherapy treatment. The results from a completed Phase IIb trial (PLIANT), where patients with metastatic colorectal cancer were treated with the chemotherapy combination FOLFOX and PledOx®, indicates that the patients who received PledOx® had a lower risk than the placebo group to suffer from nerve damage during the chemotherapy. The presence of the investigator reported sensory nerve damage, the primary endpoint, was after treatment 38% lower in the group of patients treated with PledOx® compared with the placebo group (p = 0.16). This was not statistically significant, but a difference of this magnitude is considered to be clinically relevant. After completion of chemotherapy, the patient-reported incidence of moderate and severe neuropathy was 77% lower in patients treated with PledOx® compared to the placebo group (exploratory analysis; p = 0.014). This is considered valuable for the success of the forthcoming POLAR studies, where patient-reported symptoms after completion of treatment will be the primary efficacy parameter. No apparent negative effect on the efficacy of the cancer treatment was observed. The phase III program for PledOx® consists of two double blinded randomized placebo controlled trials, POLAR-M and POLAR-A. POLAR-M includes 420 patients undergoing chemotherapy treatment for metastatic colorectal cancer and planned to be conducted in Asia, Europe and the US. The study compares PledOx® at doses of 2 µmol/kg and 5 µmol/kg with placebo. POLAR-A includes 280 patients undergoing adjuvant chemotherapy treatment for colorectal cancer and planned to be conducted in Asia and Europe. The study compares PledOx® at a dose of 5 µmol/kg with placebo.
PledPharma develops new drugs that protect the body against oxidative stress – a potentially debilitating and sometimes life-threatening condition that can be caused by chemotherapy treatment and following acetaminophen (paracetamol) overdose. The company's most advanced project PledOx® is being developed to reduce nerve damage associated with chemotherapy. A phase IIb study has been conducted and serves as the basis for the initiated global phase III program. The drug candidate Aladote® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning. A proof of principle study has been conducted and will serve as the basis for the continued development. PledPharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel +46 8 463 80 00). For more information, see http://www.pledpharma.se/
This information is information that PledPharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET on November 8, 2018.