Delayed delivery of study drug for the PledOx® phase III program – top-line results still expected during 2020, in line with previous communication
February 8, 2018
PledPharma AB, today announces a delay in delivery of study drug for the PledOx® phase III program. Enrolment of patients are now expected to commence during the second half of 2018. All other study start-up activities are progressing according to plan and the study design has recently been accepted by the FDA, the central ethics committee in the US and the health authority, MHRA in the UK. Top-line results are expected in the second half of 2020, which is within previously communicated guidance.
PledOx® is a drug candidate in development for the prevention of chemotherapy induced peripheral neuropathy in colorectal cancer patients. The global phase III program for PledOx consists of two double-blinded, randomized, placebo-controlled studies: POLAR-M (US and Europe) and POLAR-A (Europe). In November 2017, Pledpharma, together with its Asian partner Solasia Pharma K.K., announced plans to expand the program to include Asian patients, subject to regulatory consultation. To support the expansion, a phase I study is currently being conducted in Japanese and Caucasian healthy volunteers.
The delivery of study drug from the external manufacturer has not been supplied according to plan. This will result in a delay of first-patient-in (FPI) in the global phase III program. As per the current plan, FPI is expected in the second half of 2018. Diligent efforts have been put in place to minimize the delay. All other study start-up activities are progressing according to plan. The US FDA, the central ethics committee in the US and the health authority in the UK, MHRA, have recently accepted the study design, and the process to contract study centers are ongoing. Top-line results are expected in the second half of 2020, which is within previously communicated guidance.
“Despite the delay in delivery of study drug, we are still expecting top-line results from the phase III program during 2020, which is in-line with previous communication. Adequate measures have been put in place to ensure the delivery of study drug and in parallel we are working to minimize the total time of patient inclusion.”, said Nicklas Westerholm, CEO, PledPharma.
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.
About chemotherapy induced peripheral neuropathy (CIPN)
Peripheral neuropathy symptoms are caused by damages to sensory nerves, most commonly in hands and feet. Certain chemotherapies, including oxaliplatin, can cause such damages, which is then called chemotherapy induced peripheral neuropathy (CIPN). This can be a debilitating adverse reaction of the cancer treatment and may occur at any time after the initiation of chemotherapy. The symptoms often increase as the chemotherapy treatment continues and may often causes discontinuation of the chemotherapy. In many patients, the symptoms are resolved after discontinuing the chemotherapy, but up to 20-30% of the patients have sustained symptoms such as numbness, tingling and pain in hands and feet. Patients with CIPN may have difficulties with fine motor skill, such as buttoning buttons, challenges using a computer key board and become hypersensitive to cold. The sensory loss in the feet’s may increase the risk of falls. There is currently no approved drug to prevent or treat CIPN.
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 will serve as the basis for the continued development. The drug candidate Aladote® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning. 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 https://www.egetis.com/
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 FEB 8, 2018.