A1M Pharma To Raise SEK 213 Million For Phase I/II ROSGard PPRT Kidney Damage Trials

A1M Pharma has announced it intends to raise SEK 123 Million through a share issue to fund Phase I/II trials of its lead candidate drug ROSGard™. The decision comes following promising preclinical animal data showing a protective effect of ROSgard on the kidneys in conjunction with Peptide Receptor Radionuclide Therapy, PRRT, a type of molecular targeted therapy used to treat tumours, commonly malignant tumours with the generic term neuroendocrine tumours or NETs. The kidneys need to be protected since they are key to ridding the body of the administered radiation.

One of the preclinical studies showed that radiation damage occurring within 8 days of PRRT treatment was largely eliminated in the group receiving the active substance in ROSGard (RMC-035) in connection with the radiation therapy session. In the second study, which focussed on long-term kidney injuries by monitoring for 6 months after radiation therapy, the results indicated that RMC-036 has a strong protective effect against renal damage (all analyses not yet completed).

“Whilst we will continue development work on our original ROSGard™ indication for pre-eclampsia, we have been encouraged by recent preclinical results to move our main focus towards the much larger patient population affected by kidney damage during cancer therapy,” says A1M Pharma CEO Tomas Eriksson. “To fund this development we have decided upon the new share issue, in conjunction with a move to Nasdaq First North Stockholm. “We envision patient enrolment at the beginning of 2018.”

The company aims to accelerate clinical development by adopting an adaptive study design including modifying dosage dependent on patient response. The intention is to apply for orphan drug indication and fast-track approval. The safety data in phase I will also be used for the clinical file for the indication pre-eclampsia.

Time lines are to initiate the clinical studies starting with safety studies in healthy volunteers in the beginning of 2018 and presentation of initial data Q3-Q4, 2018.

Eriksson also confirmed the company’s continuing strategy of seeking an out licensing partner at the end of Phase II trials.

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