Stockholm, Tokyo, Japan - PledPharma AB ('PledPharma') (STO: PLED) and Solasia Pharma KK ('Solasia') (TSE: 4597) today jointly announce that PledOx did not reach the effect target in the prematurely terminated phase 3 program POLAR. Decisions on further development of PledOx will be made together with Solasia based on further evaluation of the results from the POLAR studies.

In the efficacy analysis, based on patient-reported symptoms of moderate or severe chemotherapy -induced peripheral neuropathy (CIPN) with the validated FACT / GOG-NTx instrument, data from both the POLAR A study and the POLAR M study were combined. PledOx 5 ?mol / kg in combination with chemotherapy did not reduce the risk of moderate to severe CIPN 9 months after the first cycle of chemotherapy compared with chemotherapy alone.

The incidence and type of adverse reactions observed were generally as expected given chemotherapy and the patient population studied. No negative effect of chemotherapy anti-cancer effect was observed with PledOx for PFS ( Progression-free survival ; PFS), overall survival ( overall survival , OS) and disease free survival ( disease-free survival , DFS), although based on a limited amount of data. As previously identified by the Independent Drug Safety Monitoring Board (DSMB) at the time the POLAR program was stopped prematurely, an increased risk of allergic hypersensitivity reactions was observed, with a few patients experiencing a serious adverse event., SAE) with PledOx in combination with chemotherapy. The severe allergic hypersensitivity reactions occurred exclusively after repeated dosing.

The study results will be presented at an upcoming scientific conference.

'The negative result in the efficacy analysis of the POLAR program is very disappointing, as nerve damage associated with platinum-based chemotherapy is an important medical need. Based on further evaluation of the results, we will decide whether further development of PledOx is justified together with Solasia. As previously communicated, our full focus is on building a specialized pharmaceutical company for the development of orphan drugs in the late phase with Emcitate and Aladote and their respective registration-based studies ', says Nicklas Westerholm, President and CEO, PledPharma.

'We are disappointed that the efficacy target for CIPN could not be achieved in the combined analysis of the POLAR M and POLAR A studies. With regard to future development strategies, we plan to evaluate and discuss the study results in detail with our partner PledPharma, 'says Yoshihiro Arai, President and CEO, Solasia.

Contact:

Nicklas Westerholm

CEO

Tel. 073 354 20 62

nicklas.westerholm@pledpharma.se

This information is such information that PledPharma is required to publish in accordance with the EU Market Abuse Regulation. The information was submitted, through the care of the above contact person, for publication on 2020-12-15 08:00 CET.

About PledPharma

PledPharma is a drug development company with a unique and integrated drug development expertise that focuses on improving the treatment of serious medical conditions with great medical need. Aladote is a 'first-in-class' drug candidate that is being developed to reduce acute liver damage due to paracetamol poisoning. A proof of principle study has been successfully completed and the design of a registration-based phase II / III study with the aim of applying for market approval in the USA and the EU has been finalized through discussions with the FDA, EMA and MHRA. Aladote has been granted orphan drug status in the United States. Through the acquisition of Rare Thyroid Therapeutics, the clinical portfolio also includes Emcitate, for the treatment of MCT8 deficiency, a rare disease with a great medical need and no treatment available. A registration-based intervention study (phase IIb / III) is planned to start in Q4 2020. Emcitate has been granted orphan drug status in the USA and Europe. The Phase III program POLAR with the drug candidate PledOx was terminated prematurely during the second quarter of 2020. Results from the POLAR program announced in December 2020 show that PledOx did not meet the efficacy measure. Based on further evaluation of the results of the POLAR studies, the next strategic steps for PledOx will be decided together with our partner Solasia. The company is currently being renamed Egetis Therapeutics in accordance with a decision made at the Extraordinary General Meeting on December 11, 2020. Emcitate has been granted orphan drug status in the United States and Europe. The Phase III program POLAR with the drug candidate PledOx was terminated prematurely during the second quarter of 2020. Results from the POLAR program announced in December 2020 show that PledOx did not meet the efficacy measure. Based on further evaluation of the results from the POLAR studies, the next strategic steps for PledOx will be decided together with our partner Solasia. The company is currently being renamed Egetis Therapeutics in accordance with a decision made at the Extraordinary General Meeting on December 11, 2020. Emcitate has been granted orphan drug status in the United States and Europe. The Phase III program POLAR with the drug candidate PledOx was terminated prematurely during the second quarter of 2020. Results from the POLAR program announced in December 2020 show that PledOx did not meet the efficacy measure. Based on further evaluation of the results of the POLAR studies, the next strategic steps for PledOx will be decided together with our partner Solasia. The company is currently being renamed Egetis Therapeutics in accordance with a decision made at the Extraordinary General Meeting on December 11, 2020. Based on further evaluation of the results of the POLAR studies, the next strategic steps for PledOx will be decided together with our partner Solasia. The company is currently being renamed Egetis Therapeutics in accordance with a decision made at the Extraordinary General Meeting on December 11, 2020. Based on further evaluation of the results of the POLAR studies, the next strategic steps for PledOx will be decided together with our partner Solasia. The company is currently being renamed Egetis Therapeutics in accordance with a decision made at the Extraordinary General Meeting on December 11, 2020.

PledPharma (STO: PLED) has been listed on Nasdaq Stockholm's main list (STO: PLED) since 31 October 2019. For more information, see www.pledpharma.se .

About PledOx and the POLAR program

PledOx is a 'first in class' drug candidate developed to prevent nerve damage that can occur in connection with chemotherapy for patients with colorectal cancer ( CRC) who receive adjuvant treatment after surgery or treatment for metastatic CRC.

The Phase III program for PledOx consists of two double-blind randomized placebo-controlled studies, POLAR M and POLAR A. The POLAR A and POLAR M studies were initiated at the end of 2018. POLAR A was fully recruited in December 2019 and randomized 301 patients undergoing adjuvant chemotherapy for CRC with either 5 ?mol / kg PledOx or placebo in Europe and Asia. The POLAR M study aimed to randomize 420 patients undergoing chemotherapy for metastatic CRC with 2 ?mol / kg PledOx, 5 ?mol / kg PledOx or placebo. In April 2020, PledPharma and Solasia phased out the POLAR Phase III program prematurely following a recommendation from the Drug Safety Monitoring Board. The decision followed the clinical holdissued by the US Food and Drug Administration (FDA) and the French regulator, ANSM, earlier this year. Therefore, POLAR M was not completely recruited, but only a total of 291 patients were randomized. Patients enrolled in the POLAR program continued with their scheduled study procedures, while not receiving the study drug, until the data interruption during the third quarter of 2020 when all patients eligible for at least 6 cycles of active treatment had completed primary efficacy nine (9) months after initiation. of chemotherapy. Due to the less than planned number of randomized patients in the POLAR M study and the reduced dose of patients in both studies, the efficacy analysis for the POLAR program to be performed in the two studies was defined.

(C) 2020 Electronic News Publishing, source ENP Newswire