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First patient included in Phase I study aiming at supporting expansion of global Phase III program for PledOx® to include Asian patients

December 1, 2017

PledPharma AB
Company Announcement

First patient included in Phase I study aiming at supporting expansion of
global Phase III program for PledOx® to include Asian patients

Stockholm, 2017-12-01 08:00 CET (GLOBE NEWSWIRE) -- 

PledPharma AB today announces that the first set of patients have been included
in the SUNCIST Phase I study evaluating safety, tolerability and
pharmacokinetics of PledOx® in Japanese and Caucasian Healthy Volunteers.
PledPharma and its partner for development and commercialization in Asia,
Solasia Pharma K.K., aim at expanding the planned Phase III program to include
Asian patients, subject to regulatory consultation. 

PledOx® is a drug candidate in development for the prevention of chemotherapy
induced peripheral neuropathy in colorectal cancer patients. A global Phase III
program is anticipated to be initiated at the end of 2017, and top line results
are expected during 2020. 

The Phase I study will include up to 24 Japanese and 24 Caucasian healthy
volunteers, which will be randomly assigned to study treatment with PledOx® in
a single dose of 2-, 5- or 10 µmol/kg, or placebo. The objective of the study
is to gain sufficient safety, tolerability and pharmacokinetic data for an
expansion of the Phase III program to include Asian patients. 

PledPharma and Solasia recently announced that the companies have entered a
license agreement pertaining to the clinical development and commercialization
of PledOx® in Japan, China, Hong Kong, Macau, South Korea and Taiwan. 

Under the terms of this agreement, PledPharma grants exclusive development and
commercialization rights to PledOx® in the territories mentioned and Solasia
will pay upfront, development, regulatory and sales milestones of up to ~USD 83
million (SEK 700 million).* In addition, Solasia will pay industry standard
royalty rates on sales applicable for a deal pertaining to an in-licensed asset
in Phase III development. Solasia will also fully finance an expansion of the
Phase III program to include Asian patients subject to regulatory

“The initiation of this first clinical trial in Asian patients provides a
kick-start in PledPharma’s and Solasia’s recently announced ambition to develop
and commercialize PledOx® for the major Asian markets. We will work closely
with Solasia and local regulatory bodies to facilitate a swift expansion of the
Phase III program, and the data from the now commenced trial will be key during
this process” said Nicklas Westerholm, CEO, PledPharma. 

* The total value of upfront and milestone payments is up to JPY 9.3 billion.
The amount given in USD and SEK is subject to exchange rate. 

For more information, please contact:

Nicklas Westerholm, CEO, phone: +46 73 354 20 62

About PledOx®
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. 

About PledPharma
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



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