A1M Pharma announces that the company has initiated a GLP toxicology study for the active substance in the candidate drug ROSGard™ within the set time frame. The results from this study will form the basis for the application to initiate clinical studies in the beginning of 2018. Simultaneously, the company’s first large scale batch under full GMP compliance is being produced, also within the previously communicated time frame.

A1M Pharma works intensively to complete the preclinical phase for the candidate drug ROSGard™ with the aim of initiating clinical studies in the beginning of 2018. There are mainly two parts remaining. First, a toxicology study in compliance with Good Laboratory Practice (GLP) must be completed. Secondly, the manufacturing of the candidate drug must be in compliance with the existing regulations for pharmaceutical manufacturing (GMP).

The company now announces that the GLP toxicology study has been initiated within the set time frame. The practical part of the study is expected to be completed as early as mid-July, followed by analysis and evaluation. As before, the company expects the study to be completed during the fourth quarter of 2017, with the final report expected in November.

“We are now in the last stage before taking ROSGard™ to clinical phase, and it is satisfying that we keep reaching our milestones within the set time frame. I am looking forward with confidence to see the end results from the ongoing GLP toxicology study”, says A1M Pharma’s Head of Development Eddie Thordarson.

The work with validating the company’s large-scale manufacturing process of the active substance in ROSGard™ is also progressing according to plan. A1M Pharma has now initiated the manufacturing of the first large scale GMP batch, which is expected to be completed during August. Based on the pilot batch, several production parameters have been optimized to improve purity and quality as well as increase the yield of the active substance from a batch.

CordenPharma, a contract development and manufacturing organization (CDMO) which offers a full range of services within manufacturing of active pharmaceutical substances and pharmaceutical products as well as packaging services, has been chosen as partner within Fill & Finish. CordenPharma has a network of GMP certified production facilities in Europe and the United States, and the first clinical GMP batch of ROSGard™ will be manufactured at CordenPharma Caponago in Italy during the fourth quarter of 2017.

A1M Pharma aims to initiate the company´s clinical program with a safety study in healthy volunteers in the beginning of 2018. The company is now evaluating potential partners within contract research (CRO companies) for the execution of the study, and a final choice of a CRO partner is expected within the next few months.

For more information, please contact
Tomas Eriksson, CEO
Telephone: +46 46-286 50 30
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

About A1M Pharma
Several preclinical studies indicate that A1M Pharma’s candidate drug, ROSGard™, based on the endogenous protein Alpha-1-Microglobulin, restores impairments to kidney function by repairing damaged tissue and protecting against oxidative stress. Kidney injury is a condition which often occurs in connection with preeclampsia and major surgery and which often limits the possibilities of using radiation therapies as a treatment for cancer. The company’s two indications are kidney protection in connection with Peptide Receptor Radionuclide Therapy (PRRT) – a targeted radiation therapy for cancer – with the aim of opening the possibility of increasing treatment levels and so fight metastatic cancer more effectively as well as treatment of preeclampsia. Every year, over 12 million people are affected by acute kidney injuries that can lead to permanent kidney damage. Preeclampsia affects around 10 million pregnant women worldwide and is responsible for 76,000 maternal and 500,000 infant deaths each year.
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