Stockholm, January 10, 2019. PledPharma AB (publ) and Solasia Pharma K.K. announces that the first patient has been included in the global Phase III program for the drug candidate PledOx® in Japan. This constitutes an important milestone for both companies. The inclusion will trigger a payment from PledPharma's partner Solasia Pharma of 600 MJPY, equivalent to approximately 49 MSEK.
The global Phase III program for PledOx® consists of two double-blind, randomized, placebo-controlled studies - POLAR-M and POLAR-A. The Phase III program is conducted in Europe, Asia and the United States, and will include a total of 700 colorectal cancer patients undergoing chemotherapy treatment. The first patient included in the program was in the USA in November 2018, and the top line results are expected in the second half of 2020.
PledPharma entered a license agreement in November 2017 pertaining to the clinical development and commercialization of PledOx® in Japan, China, Hong Kong, Macau, South Korea and Taiwan. The total deal value amounts to approximately 83 MUSD* (equivalent to approximately 700 MSEK*) and are linked to milestones during the continued development and commercialization of PledOx®. In addition, Solasia will pay royalties on potential future sales of PledOx®. Solasia will also fully finance the Asian part of the POLAR studies.
"The partnership with Solasia Pharma is an important component of PledPharma's strategy to realize the global commercial potential of PledOx®, and it is with great satisfaction that we now see that the POLAR studies also are initiated in Asia.” says Nicklas Westerholm, CEO, PledPharma AB.
"We are extremely thrilled that Asia is part of the global Phase III program, and it was our joint collaborative effort with PledPharma that led us to achieve this huge milestone in such short time" says Yoshihiro Arai, President & CEO, Solasia Pharma K.K..
*The total deal value is 9.3 billion JPY. The amounts stated in USD and SEK may be affected by currency fluctuations.
For further information, please contact:
Nicklas Westerholm, CEO
Phone +46 (0)73 354 20 62
Yilmaz Mahshid, CFO
Phone +46 (0)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. PledOx® showed 38% effect (odds ratio=0.62; p=0.16) on investigator reported sensory nerve damage, the primary endpoint, compared with the placebo group. This was not statistically significant, but a difference of this magnitude is considered clinically relevant. After completion of chemotherapy, PledOx® showed 77% effect (odds ratio = 0.23; exploratory analysis: p=0.014) on patient-reported moderate and severe neuropathy compared to the placebo group.. 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.
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 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 successfully completed 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 83 00, email@example.com). For more information, see http://www.pledpharma.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 January 10, 2019.