PledPharma AB ('PledPharma') (STO: PLED) today announced that the US Food and Drug Administration (FDA) has issued a 'clinical hold' in the US of the Phase III program POLAR for the drug candidate PledOx.

The FDA's decision means that a break will occur in patient recruitment and dosing in the POLAR-M study in the United States. Based on an evaluation of the independent 'Drug Safety Monitoring Board' (DSMB), PledPharma's position is that the overall safety profile of PledOx supports a continuation of the POLAR program and both studies will proceed as planned in Europe and Asia.

The global Phase III program POLAR for PledOx consists of two double-blind, randomized, placebo-controlled studies, POLAR-M and POLAR-A. POLAR-A includes patients undergoing adjuvant chemotherapy for colon and rectal cancer and is being implemented in Europe and Asia and was fully recruited in December 2019. Recruitment in POLAR-M is underway and includes patients undergoing cellular chemotherapy for metastatic colon and rectal cancer and are being conducted in Europe, Asia and the United States. The clinical stay of the POLAR program issued by the FDA currently involves a break in the recruitment and dosing of patients in POLAR-M in the United States. Patients who are already included in the study will be able to continue their planned visits and procedures in addition to the dosing of study drugs.

The decision by the FDA is made for safety reasons and is based on a few observed cases of side effects. The independent DSMB committee for the POLAR program has evaluated the same case of side effects and has recommended that the POLAR studies should continue as planned. In order to ensure the safety of patients in our clinical studies, PledPharma has conducted a comprehensive review of all available clinical and preclinical data and concludes that the safety profile of PledOx supports the continuation of the POLAR program as planned. Both POLAR studies will continue to recruit and dose patients as planned in Europe and Asia to enable the collection of additional data on the PledOx benefit / risk profile.

PledPharma will continue to work with the FDA and provide them with the necessary information to cancel the clinical stay as soon as possible. Other regulatory agencies involved in the POLAR program will be informed of the clinical stay in the United States.

'Patient safety in our clinical trials is our most important responsibility. Approximately 2,700 doses of calmangafodipir have been administered in approximately 500 patients to date in clinical trials. Our review of available clinical and preclinical data supports the continuation of the POLAR program and this image is shared by DSMB. We will work closely with the FDA and provide them with the necessary information to get the recruitment of POLAR-M patients in the US as soon as possible, 'said Nicklas Westerholm, President and CEO, PledPharma.

Contact:

Nicklas Westerholm

Tel: 073 354 20 62

Email: nicklas.westerholm@pledpharma.se

About us

PledPharma is a drug development company with a unique and integrated drug development competence that focuses on improving the treatment of serious medical conditions with great medical need. PledOx is a 'first-in-class' drug candidate, intended for the prevention of nerve damage in conjunction with chemotherapy. A global phase III program is in progress. Aladoteis a 'first-in-class' drug candidate that is developed to reduce acute liver damage as a result of acetaminophen poisoning. A proof of principle study has been successfully completed and the design of the next study is being finalized. Aladote has been granted oral drug status in the United States. PledPharma is headquartered in Stockholm. The share is listed on Nasdaq Stockholm's main list (STO: PLED), since October 31, 2019.

This information is such information that PledPharma is required to disclose in accordance with the EU Market Abuse Regulation. The information was submitted, for publication by the above contact person, for publication on 2020-01-23 08:46 CET.

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