A1M Pharma finalizes drug candidate for treating pre-eclampsia and files for substance patent

A1M Pharma has developed a new drug candidate for treating pre-eclampsia based on a modified version of the natural protein alpha-1-microglobulin (A1M). Applications for substance patents have been filed in major geographical markets, significantly strengthening A1M Pharma’s intellectual property portfolio.

A1M Pharma is developing a treatment and diagnostics for pre-eclampsia as well as a therapy for acute kidney injury based on the endogenous protein alpha-1-microglobulin (A1M). A1M occurs naturally in the body, and is an important component of the protective mechanism against the harmful effects of oxidative stress.

Previously, A1M Pharma had produced a recombinant version of A1M with the positive characteristics of the natural protein, although it had not been possible to patent the compound. Now, however, after an intensive research program, the company has succeeded in producing the new drug candidate, RMC-035. This new candidate, a modified version of A1M, has demonstrated equal efficacy to the natural compound in the company’s tests, as well as more stability in use, and is easier to manufacture on a large scale. These modifications compared to the natural A1M protein have enabled A1M Pharma to file for a substance patent.

Commenting, Eddie Thordarson, A1M Pharma’s Director of Medical Affairs said: “The completion of our new drug candidate RMC-035 for treating pre-eclampsia is a milestone in A1M Pharma’s development, when we really take the leap from being a research enterprise to a pharmaceutical company undertaking clinical trials. We can now continue our work on a very promising drug candidate, which in addition to having A1M’s unique qualities, is very well suited for medical usage and large-scale manufacture.”

The completion of the new drug candidate, with the potential of being granted a substance patent, and the company's demonstrated ability to modify A1M's characteristics, is also expected to trigger greater interest in A1M Pharma with potential collaborative partners and other sector players. This applies to current projects and the company’s future potential in other indications.

“Generally, drug candidates with the potential to secure substance patents are valued far more highly than natural compounds, while simultaneously, a natural origin is promising because it indicates high likelihood that the product will be tolerated by the body,” added Martin Austin, A1M Pharma’s Business Development Director. “Our new drug candidate demonstrates that A1M Pharma can combine the best of both worlds, and make us an even more attractive collaborative partner than before.”

In the near term, the company plans to present an updated schedule of forthcoming milestones on its project on the treatment of pre-eclampsia, including GMP upscaling of pharmaceutical production. Adopting to the new drug candidate is expected to cause no delays, and to increase the reliability of forthcoming planning.

For more information, please contact:
Tomas Eriksson, CEO of A1M Pharma AB
Tel: +46 (0)46 286 50 30
Email: te@a1m.se

About A1M Pharma

A1M Pharma develops a diagnostic method and treatment for pre-eclampsia, a condition that affects around 10 million pregnant women worldwide each year. This disorder is responsible for 76,000 maternal and 500,000 infant deaths each year and it is the cause of 15 % of all premature births. Currently, there is no effective diagnostic method or curative treatment for impaired kidney function associated with pre-eclampsia. The only option is therefore to terminate pregnancy by inducing delivery which leads to premature infants and substantial health care costs. Several studies indicate that A1M Pharma’s candidate drug, the protein A1M (alpha-1-microglobulin), restores the impaired kidney function by repairing damaged tissue and protect against oxidative stress. New findings indicate that the cells within the heart are protected in a similar way. Apart from the connection with pre-eclampsia, kidney injury is a condition often accompanying major surgery and transplantation and the company is therefore also developing a treatment for the closely related indication acute kidney injury. Acute kidney injury that can lead to permanent kidney damage affects 12 million people every year.

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