A1M timetable

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
Phase I/II 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

A small number of process parameters are currently being adjusted within the large-scale manufacture of the active substance in the drug candidate ROSgard. During the second quarter of 2017 manufacture of the substance will commence in accordance with applicable rules and regulations for pharmaceutical manufacture (GMP). During Q2, registrational GLP toxicity studies are also set to begin.

Kidney protection in connection with radiation therapy
Trials in mice taking place during the first and second quarters of 2017 involve tumour treatment and follow-up of renal function for up to six months after the treatment session. The clinical Phase I/II trials are being planned in parallel, and a CRO partner is expected to be chosen during the third quarter of 2017. Clinical trials (safety study in healthy volunteers followed by an adaptive Phase I/II trial) are scheduled to begin during the first quarter of 2018.

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. Assuming approval is granted, a change of listing to Nasdaq First North Stockholm will be implemented during the first half of 2017.
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