A1M Pharma's candidate drug ROSgard™ shows protective effect against acute kidney injury in American preclinical study

A1M Pharma announces that the company's candidate drug ROSgard™ shows a strong protective effect against acute kidney injury (AKI) in a preclinical study conducted in the USA in collaboration with Indiana University. The positive results correlate well with recently reported results from a similar study conducted in Europe. The company has thus created an increasingly solid basis for the continued development of ROSgard™ in the field of acute kidney injuries. A phase I study is scheduled to start later in 2018, with the primary aim of evaluating the candidate drug's safety profile.

The preclinical AKI study in the USA was conducted with another animal species and with a partially different method compared to the study in Europe. The results show that the placebo group displayed a substantial increase of AKI biomarkers while the groups that were administered with ROSgard™ displayed a significant reduction in all biomarkers.

"With these preclinical results we are now well positioned to study different pathophysiological conditions that are known to lead to AKI together with world leading companies based in the USA as well as Europe, each specialized in their unique subclinical field of AKI. The follow-up studies that we are now planning in Europe and the USA will provide a valuable basis for the design of future clinical studies with ROSgard™ within AKI," says A1M Pharma's Head of Development Eddie Thordarson.

"The clear and positive results from the AKI studies in the USA and Europe provide further evidence that ROSgard™ has the potential to help patients at risk of developing kidney injuries. The fact that the results are based on two different models in which both animal species and approach differ is a sign of strength. Today, there are no specific therapies to treat AKI and the interest in new treatments is immense, both from healthcare professionals and global pharmaceutical companies," says A1M Pharma's CEO Tomas Eriksson.

The American AKI study was led by professor Bruce Molitoris, a past President of American Society of Nephrology.

A1M Pharma's preclinical program in acute kidney injury is independent of the company's application to the Swedish Medical Products Agency regarding the conduct of a clinical phase I study and does not impact the schedule for clinical trials with ROSgard.

About acute kidney injuries The kidneys are not only the body's treatment plant, they are also the control centre for the vital function of blood pressure regulation and thus the balance of salt and water in the body. This means that by and large, impaired kidney function affects all bodily functions. Acute kidney injury can occur in the event of incidents such as poisoning and infections, and in connection with severe bleeding, oxygen deprivation or certain types of cancer treatments and importantly in the context of major cardiac surgery. Kidney injuries can also be caused by diabetes, high blood pressure and glomerulonephritis, which is an inflammatory condition in which the kidney's filtration units (called 'glomeruli') are damaged. In all these cases, oxidative stress is an important contributing factor to the injuries. If the injuries are extensive, chronic kidney failure can result, which requires dialysis or a kidney transplant.

2018-08-10

For more information, please contact
Tomas Eriksson, CEO
Telephone: +46 46-286 50 30
Email: te@a1m.se

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 tissue and protecting against oxidative stress. Kidney injury is a condition which often occurs in connection with preeclampsia and which often limits the possibilities of using radiation therapies as a treatment for cancer. The company's two indications are kidney protection in connection with Peptide Receptor Radionuclide Therapy (PRRT) - a targeted radiation therapy for cancer - with the aim of opening the possibility of increasing treatment levels and so fight metastatic cancer more effectively as well as treatment of preeclampsia. Every year, over 12 million people are affected by acute kidney injuries that can lead to permanent kidney damage. Preeclampsia affects around 10 million pregnant women worldwide and is responsible for 76,000 maternal and 500,000 infant deaths each year. A1M Pharma is listed on Nasdaq First North Stockholm since 20 June 2017. A1M Pharma's Certified Adviser at Nasdaq First North is Erik Penser Bank AB, +46 8-463 80 00.

This information is information that A1M Pharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was provided, through the above contact, for publication on the 10 August 2018 at 15.00.

Styrelseförändring i A1M Pharma

A1M Pharma meddelar idag att Helena Brounéus beslutat sig för att lämna sitt uppdrag som styrelseledamot.


A1M Pharma lämnar in förnyad ansökan till Läkemedelsverket om klinisk prövning med ROSgard™

A1M Pharma meddelar idag att bolaget har lämnat in en förnyad ansökan till Läkemedelsverket om genomförande av en fas I-studie med ROSgard™ - en läkemedelskandidat som i flera prekliniska studier visat sig ha en skyddande effekt mot njurskador i samband med oxidativ stress. Givet godkännande är fas I-studien planerad att inledas under det fjärde kvartalet 2018.


A1M Pharma re-submits application to the Swedish Medical Products Agency to conduct clinical trial with ROSgard™

A1M Pharma announces that the company has re-submitted the application to the Swedish Medical Products Agency (Läkemedelsverket) to conduct a clinical phase I study with ROSgard™ - a candidate drug that has shown a protective effect against kidney injuries in connection with oxidative stress in several preclinical studies. Upon approval, the phase I study is scheduled to start in Q4 2018.


Delårsrapport 2018-01-01 till 2018-06-30

Sammanfattning av delårsrapport

Första halvåret (2018-01-01 - 2018-06-30)

  • Intäkterna uppgick till 0 SEK (0).
  • Resultatet efter finansiella poster uppgick till -29 890 SEK (-34 294).
  • Resultatet per aktie uppgick till -1,44 SEK (-4,25).
  • Soliditeten uppgick per den 30 juni 2018 till 84 % (90). 

Andra kvartalet (2018-04-01 - 2018-06-30)

  • Intäkterna uppgick till 0 SEK (0).
  • Resultatet efter finansiella poster uppgick till -14 784 SEK (-18 603).
  • Resultatet per aktie uppgick till -0,71 SEK (-2,31).

Belopp inom parentes: Jämförande period föregående år.
* Resultat per aktie: Periodens resultat dividerat med 20 746 840 utestående aktier per den 30 juni 2018 (8 064 105).

** Soliditet: Eget kapital dividerat med totalt kapital.


A1M Pharma prioriterar indikationen akut njurskada i den fortsatta utvecklingen av ROSgard™ baserat på positiva prekliniska data

A1M Pharma meddelar idag att bolaget beslutat prioritera indikationen akut njurskada i samband med hjärtkirurgi i den långsiktiga kliniska utvecklingsplanen för läkemedelskandidaten ROSgard™. Detta baserat på nyligen kommunicerade positiva resultat från prekliniska studier i relevanta försöksmodeller. Efter genomförandet av en fas I-studie i friska frivilliga, från vilken resultat förväntas under första halvåret 2019, planeras en fas Ib-studie i denna patientgrupp för att studera säkerhet och utvärdera farmakodynamiska effekter.


A1M Pharma to prioritize the indication acute kidney injuries in further development of ROSgard™ on the basis of positive preclinical data

A1M 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.


A1M Pharma rekryterar Chief Medical Officer

A1M Pharma meddelar att bolaget har rekryterat Tobias Larsson Agervald som bolagets nye Chief Medical Officer (CMO). Tobias Larsson Agervald är docent och specialistläkare inom invärtesmedicin och njurmedicinska sjukdomar och har omfattande erfarenhet inom global forskning och läkemedelsutveckling i både tidig och sen fas. Han tillträder tjänsten som CMO den 1 december 2018.


A1M Pharma appoints Chief Medical Officer

A1M Pharma announces that the company has appointed Tobias Larsson Agervald as its new Chief Medical Officer (CMO). Tobias Larsson Agervald is an associated professor and specialist in internal medicine and nephrology with extensive experience in global research and development of pharmaceuticals in both early and later clinical stages. He will assume the position on December 1, 2018.


A1M Pharmas läkemedelskandidat ROSgard™ skyddar mot akut njurskada i amerikansk preklinisk studie

A1M Pharma meddelar att bolagets läkemedelskandidat ROSgard™ visar stark skyddseffekt mot akut njurskada (AKI) i en preklinisk studie som genomförts i USA tillsammans med Indiana University. De positiva resultaten sammanfaller väl med de som nyligen rapporterades från en liknande studie vilken genomförts i Europa. Under den senaste tiden har bolaget således skapat ett alltmer solitt underlag för fortsatt utveckling av ROSgard™ inom området akuta njurskador. En fas 1-studie är planerad att inledas senare under 2018 med det primära syftet att utvärdera läkemedelskandidatens säkerhetsprofil.


A1M Pharma's candidate drug ROSgard™ shows protective effect against acute kidney injury in American preclinical study

A1M Pharma announces that the company's candidate drug ROSgard™ shows a strong protective effect against acute kidney injury (AKI) in a preclinical study conducted in the USA in collaboration with Indiana University. The positive results correlate well with recently reported results from a similar study conducted in Europe. The company has thus created an increasingly solid basis for the continued development of ROSgard™ in the field of acute kidney injuries. A phase I study is scheduled to start later in 2018, with the primary aim of evaluating the candidate drug's safety profile.


A1M Pharma rapporterar positiva resultat från preklinisk studie inom akuta njurskador

A1M Pharma rapporterar idag positiva resultat från en preklinisk studie inom området akuta njurskador (AKI). De primära effektmåtten visar att den aktiva substansen i bolagets läkemedelskandidat ROSgard™ signifikant reducerar de skadliga effekterna på njurarna när dessa utsätts för kraftig oxidativ stress.


A1M Pharma reports positive results from preclinical study in acute kidney injuries

A1M Pharma today reports positive results from a preclinical study in the field of acute kidney injury (AKI). The primary endpoints show that the active substance in the company's candidate drug, ROSgard™, significantly reduces the damaging effects on kidneys following exposure to severe oxidative stress.


A1M Pharma byter tillverkningspartner av läkemedelskandidaten ROSgard™

A1M Pharma meddelar idag att bolaget har bytt tillverkningspartner för läkemedelskandidaten ROSgard™ till den kliniska fas I-studien. Bytet av tillverkningspartner förväntas inte påverka tidsplanen för fas I-studien som är planerad att inledas under fjärde kvartalet 2018. Bolaget avvaktar med inlämnandet av den förnyade ansökan till Läkemedelsverket till dess att data från den nya produktionen av läkemedelskandidaten finns att tillgå.


Förnyad ansökan till Läkemedelsverket under juli - klinisk prövning med ROSgard™ förskjuts ett kvartal

A1M Pharma meddelar idag att kompletterande data i bolagets ansökan som tidigare begärts av Läkemedelsverket har genererats och att bolaget räknar med att lämna in en förnyad ansökan till Läkemedelsverket under juli 2018. Sammantaget beräknas tidsplanen för klinisk prövning med ROSgard™ förskjutas drygt tre månader.


Kommuniké från årsstämma i A1M Pharma

Idag, den 31 maj 2018, hölls årsstämma i A1M Pharma AB (publ). Nedan följer en sammanfattning av de beslut som fattades. Samtliga beslut på årsstämman var eniga.


Följ oss

Om beQuoted

beQuoted publicerar nyheter, analyser och pressmeddelanden för investerare och journalister. Viktiga företagshändelser bevakas av vår egen nyhetsredaktion och vidaredistribueras i ledande finansiella medier.

Vi uppdaterar även nyhetsrum, Investor Relations och IR-webbplatser för företag som vill utveckla sina relationer med finansmarknaden.

Kontakta oss

beQuoted AB
Sturegatan 32
114 36 Stockholm

08-692 21 90
Kontaktformulär

Kontakta oss

Vill du veta mer om beQuoted och våra tjänster så fyll i nedanstånde uppgifter och tryck skicka.

En av våra rådgivare kontaktar dig inom kort.

Namn: Telefon: E-postadress: Meddelande: