A1M Pharma to prioritize the indication acute kidney injuries in further development of ROSgard™ on the basis of positive preclinical dataA1M Pharma is today announcing the company's decision to prioritize the indication acute kidney injuries in conjunction with heart surgery in the long-term clinical development plan for the drug candidate ROSgard™. This decision is based on the recently communicated positive results from preclinical studies in relevant research models. After completion of a Phase I trial in healthy subjects, the results of which are expected in the first half of 2019, a Phase Ib trial is planned in this patient group to study safety and evaluate the pharmacodynamic efficacy. Work to prepare for clinical development in the indications preeclampsia and PRRT (kidney protection in connection with radiation therapy) will continue, but will be a lower priority than in the past. The development of a new treatment for preeclampsia remains one of the company's long-term objectives.
"As previously communicated, A1M Pharma has evaluated additional potential indications where ROSgard's tissue-protective effects can fulfil their full potential. Having noted the clear and positive results from two mutually independent preclinical trials in the field of acute kidney injuries, it was an easy decision for the Board to reprioritize the company's long-term clinical development program," says A1M Pharma's CEO Tomas Eriksson.
"There are currently no specific drug treatments for acute kidney injuries, an indication with exceptionally good prospects to swiftly document clinical efficacy. The commercial potential is also significant and the regulatory development path is well-defined," comments A1M Pharma's incoming CMO Tobias Larsson Agervald.
The design, costs and timeline for the already planned Phase I trial will in no way be affected by this reprioritization. August 15, 2018 For additional information, please contact:
Tomas Eriksson, CEO
Telephone: +46 46 286 50 30
E-mail: [email protected]
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A1M Pharma Pressrelease 2018-08-15 English.pdf 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 tissues and protecting against oxidative stress. A1M Pharma is listed on Nasdaq First North Stockholm. A1M Pharma's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8 463 80 00.
This information is of the type that A1M Pharma (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. This information was provided to the media, through the agency of the contact person set out above, for publication on August 15, 2018 at 11:45 a.m. CEST.
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