A1M Pharma has conducted trials which show that ROSgard™ provides increased kidney protection in connection with radiation therapy of neuroendocrine cancerous tumours (PRRT). For that reason, we are proceeding with the clinical development of ROSgard in a selected group of patients who are receiving PRRT. It is our assessment that the conditions exist for rapid clinical results.

Having first achieved clinical Proof of Concept for ROSgard, it will be possible to support the development of other indications, in particular impaired kidney function as a result of pre-eclampsia – which has been our main aim from the beginning. It is also our assessment that clinical Proof of Concept will facilitate the process of attracting potential partners.

From drug candidate to finished product
Clinical trials are scheduled to begin in early 2018. There will first be a safety study in healthy volunteers. This study will be followed by safety and efficacy studies involving patients receiving PRRT. An adaptive design will be used, i.e. the study may be adapted depending on the resulting safety and efficacy data.

A1M Pharma has decided to follow the new strategy in order to get ROSgard to market more quickly and to increase the value of the intellectual property rights.

Timetable for development of the drug candidate ROSgard

Timetable

Joint preclinical development

In Q4 2017, the world's first large-scale batch of the active substance in the drug candidate ROSgard™ was manufactured, in accordance with current GMP regulations. During this quarter, registration-based GLP toxicity studies were also completed with positive results.

Kidney protection in connection with radiation therapy
A1M Pharma has signed an agreement with the Swedish contract research organization Clinical Trials Consultants (CTC) about a collaboration for conducting the company’s upcoming phase I/II studies. 31 January 2018, the company submitted an application to the Swedish Medical Products Agency (Läkemedelsverket) to conduct a clinical phase I study in healthy volunteers with the candidate drug ROSgard™. The Swedish Medical Product Agency’s policy is to notify their decision within 60 days when they have received and started processing an application to conduct a clinical study.

Pre-eclampsia
Planning prior to the clinical phase, including discussions with regulatory authorities, is being coordinated with the clinical trials within kidney protection in connection with radiation therapy. In the best case scenario, a Phase II trial can be implemented based on data from these trials. Development of a diagnostic solution for individual adaptation (companion diagnostics) is scheduled with a view to out-licensing the diagnostic method together with the treatment method.

Other activities
Evaluation of additional potential indications is continuing. Two fields where the company’s A1M-based substances have shown good early preclinical results are cardiovascular diseases (hardening of the arteries) and eye diseases.
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