Summary
Q1 IN BRIEF
- The study design for PledOx® Phase III program has been approved by the UK Medicines Agency MHRA and accepted by the US FDA and the Central Ethics Committee of the United States
- PledOx® shows favorable safety and tolerability profile in the SUNCIST Phase I study in Japanese healthy volunteers
- Delayed delivery of study drug for the PledOx® phase III program – top-line results still expected during 2020, in line with previous communication
- PledPharma receives European patent approval for the composition of matter patent for PledOx® and Aladote®
- Investigator meeting for POLAR-M was held in March in Orlando, USA
- Dialogues with Asian regulatory agencies was initiated together with our partner Solasia Pharma
- The Aladote® DSMB (Data and Safety Monitoring Board) approved the initiation of the final and last dose cohort in the proof of principle study. The three first patients in the dose cohort were treated in the quarter.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
- A meeting with the Japanese healthcare authority, PMDA, was held in April with the focus on an expansion of the POLAR studies in to Japanese patients
- All planned submissions of clinical trial applications to health agencies and ethical committees for PledOx® in Europe was finalized
- The European investigator meeting for the POLAR studies was held in Barcelona, Spain
- Further two patients were treated with Aladote® in the final and last dose cohort. In total 21 out of planned 24 patients have been treated in the study
- The company strengthened its internal competency within development and manufacturing of pharmaceutical product with the recruitment of Anders Sveno
FINANCIALS FOR THE QUARTER
- Quarterly result MSEK -15,8 (-12,3)
- Cash position MSEK 294,3 (382,0)
- Cash flow from operating activities
MSEK -15,2 (-12,0) - Result per share SEK -0,3 (-0,3)
COMMENTS FROM THE CEO
Our preparations for the initiation of the phase III program for PledOx® – a drug candidate for the prevention of CIPN – continued during the first quarter at high pace. The results from the phase I study (SUNCIST), which was initiated in December 2017, to evaluate our drug candidate in Japanese healthy volunteers was, after an efficient execution, communicated already in February. PledOx® showed a favorable safety and tolerability, which merits further clinical development in Asian patients together with our regional partner, Solasia Pharma. Simultaneously, our proof-of-principle study with Aladote® progressed according to plan. In total, five out of eight planned patients in the last cohort have been included. Aladote® is being developed to prevent the development of acute liver failure caused by paracetamol overdose. We expect results from the study in the second quarter 2018.
Continued interactions with health authorities ahead of enrolment of first patient in the POLAR studies
During the first quarter, PledPharma received approval on the study design for PledOx® phase III program by the UK Medicines Agency MHRA and acceptance by the US FDA and the Central Ethics Committee of the United States. We are still expecting enrolment of patients in the POLAR studies to commence during the second half of 2018. Despite the delay in delivery of the study drug which was communicated in February, we expect to deliver top-line results during 2020, in-line with previous communication. We have submitted all the clinical trial applications to necessary agencies across the relevant countries in Europe and continued the process with contracting trial sites. We are also preparing our formal interactions with Asian Health Authorities ahead of our planned expansion of the phase III program, to this important and fast growing part of the global pharmaceutical market. During April a meeting was held with the Japanese Health care authority, PMDA, with focus on the expansion of the POLAR studies to Japan.
Additional competence in development and manufacturing of pharmaceutical product
To strengthen our internal competency within development and manufacturing of pharmaceutical product, we recruited Anders Sveno in April as Head of CMC and Supply Chain. Anders has a broad and deep technical and regulatory expertise within CMC, among others from leading positions at AstraZeneca and Meda.
IP-portfolio strengthened
Further positive news is that the European Patent Office (EPO) recently approved our composition of matter patent regarding the active ingredient in Aladote® and PledOx®. This patent is core to our broad and robust patent portfolio. The composition of matter patent gives us a strong intellectual protection until 2032 in Europe. Corresponding patent has earlier been approved in the US, Japan, China and Russia, the patent protection in these countries lasts until December 2032.
We look forward to the results from the ongoing Aladote® trial, as well as further expected regulatory approvals in Europe ahead of the inclusion of patients to our phase III program for PledOx®. The medical need for CIPN and the prevention of acute liver failure due to paracetamol overdose is high, and we will continue our dedicated and focused efforts to make our drug candidates available in the healthcare setting.
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: nicklas.westerholm@pledpharma.se E-mail: yilmaz.mahshid@pledpharma.se
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 24 April 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. PledPharma (STO:PLED) is listed on Nasdaq First North.
The company´s Certified Advisor is Erik Penser Bank (phone +46 8 463 80 00).
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