Half-Year Report January-June 2018
August 22, 2018
Summary
APRIL-JUNE IN BRIEF
- All planned submissions of clinical trial applications to health authorities and ethical committees for PledOx® in Europe has been submitted.
- The European investigator meeting for the POLAR studies was held in Barcelona, Spain
- European Medicines Agency (EMA) approved PledPharma’s waiver application for the pediatric investigation plan (PIP)
- Japanese Medical Agency (PMDA) supports the expansion of the Phase III program for PledOx® to include Japanese patients
- PledPharma has completed recruitment of all patients in the proof-of-principle study with the drug candidate Aladote®
- Aladote® is concluded as safe in the first clinical study in patients with paracetamol overdose
- PledPharma plan to apply for Orphan Drug Designation in the US for Aladote®
- PledPharma has established a Scientific Advisory Board for the continued clinical development of Aladote®
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
- The Scientific Advisory Board for Aladote® held its first meeting with focus on the design of the next study
- PledPharma’s supplier has manufactured the active pharmaceutical ingredient (API) which will now be used to finalise formulation and production of PledOx® study drug before dosing of first patient in the global phase III program. Delivery of the newly produced study drug is expected in September 2018
FINANCIAL FOR THE QUARTER, APRIL-JUNE
- Quarterly result MSEK -28.2 (-16.2)
- Cash flow from operating activities
MSEK -28.3 (-19.6) - Result per share SEK -0.6 (-0.3)
FINANCIAL FOR THE PERIOD, JANUARY-JUNE
- Loss for the period MSEK -44.0 (-28.5)
- Cash position MSEK 267.1 (363.7)
- Cash flow from operating activities
MSEK -42.5 (-31.6) - Result per share SEK -0.9 (-0.6)
COMMENTS FROM THE CEO
Every year many cancer patients are affected by potentially disabling nervdamages as a consequence of their treatment with chemotherapy. Also, every year hundreds of thousands of people are afflicted by paracetamol poisoning, which may result is severe liver damage.
PledPharma’s ambition is to develop two completely new therapies to reduce the sufferings of these patients. During the second quarter, we have taken additional important steps towards reaching our goal.
Preparations ahead of dosing of first patient in the phase III program with PledOx® are on track
Our focus continues to be on the preparations ahead of dosing of first patient in the global phase III program with PledOx® – a potentially groundbreaking treatment to prevent chemotherapy induced peripheral neuropathy. All applications to healthcare authorities and ethical committees for the execution of the POLAR-studies in Europe and the US are submitted and will be amended with data from the newly produced study drug. Subject to necessary approvals, patient recruitment can commence during the fourth quarter, this is in-line with previous communication.
We have continued to work together with our Asian partner, Solasia Pharma, to enable the expansion of our phase III program to include Asian patients, where the Japanese Healthcare agency (PMDA) has expressed its support for this ambition. The expansion of the phase III program, which is fully financed by Solasia, creates a truly global phase III program and an opportunity to materially increase the commercial potential for PledOx®.
Aladote® displays positive safety data
We took a big leap forward in our second drug project Aladote® during the quarter – a drug candidate in development for the prevention of liver damage caused by paracetamol poisoning. Recruitment of patients in the clinical proof-of-principle study was completed, and initial results indicate that Aladote® has a good safety profile and did not result in any dose limiting side effects. Currently, patients are being followed-up, and we expect full set of results in September including explorative biomarkers for liver damage. Subject to continued positive results, PledPharma plan to submit an Orphan Drug Designation application for Aladote® in the US, this will amongst others give us strengthened market protection. At the end of June, we announced that well renown internationally leading experts within the field of paracetamol poisoning, toxicology and acute medicine joins our newly established Scientific Advisory Board to optimize Aladote®’s potential and hence increase the likelihood of an approval for this meaningful drug. The first advisory board meeting was held in July with focus on the design of the next study.
To summarise, we can establish that patient inclusion in to our phase III program for PledOx® are getting closer and full set of results from the proof-of-principle study for Aladote® will be available soon. Both of these drug candidates have the potential to become new treatment options helping patient populations with clear unmet medical need. We continue to do our professional outermost for our unique assets to make them available for patients as soon as possible.
Nicklas Westerholm, CEO
Pledpharma AB
Stockholm
For further information contact:
Nicklas Westerholm, President and CEO Yilmaz Mahshid, CFO
Phone: +46 73 354 20 62 Phone: +46 72 231 68 00
E-mail: [email protected] E-mail: [email protected]
This information is such information as PledPharma AB (publ) is obliged to disclose in accordance with EU market abuse regulation and the Securities Markets Act. The information was submitted, through the above contact persons, for publication on 22 August 2018 at 8.00 am (CET).
PLEDPHARMA IN BRIEF
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 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.
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