A Decade of Passion for Resistance-Breaking Anti-Infectives
When AiCuris was founded 10 years ago in Wuppertal, as a spin-out from Bayer Pharma, anti-infectives and the problem of increasing bacterial and viral resistance to common treatments were not top of the pharmaceutical industry’s agenda. Today, however, heads of state and government talk of a resistance crisis. In the hope that it will soon see its first product on the market and with an exciting development pipeline, AiCuris established itself as “powerhouse for anti-infectives” among the sector’s major players. (Autor: Robert Steininger)
The Company has been making a name for itself in the sector at least since 2012, when AiCuris granted Merck & Co. rights to its human cytomegalusvirus (HCMV) portfolio for a record upfront payment of €110 million with milestone payments of up to €332.5 million and additional royalties on potential future product revenues. Great expectations are now being placed on the HCMV frontrunner Letermovir, which is currently in clinical Phase 3 trials with Merck to prevent CMV infection in stem cell transplant patients. With positive trial results, Letermovir could receive approval as early as next year and would be AiCuris’s first product to enter the market.
After the pipeline development was funded for more than 10 years primarily from the Strüngmann brothers (former owners of Hexal) as majority shareholders, the approval of Letermovir should mark a sustainable positive turning point for the Company’s earnings situation based on milestone and future royalty payments. And this is good, since AiCuris has new targets to explore, new modes of action to discover and new drugs to develop.
A second exciting project in development is the herpes simplex virus (HSV) inhibitor Pritelivir, which is in clinical Phase 2 trials. Pritelivir has a new mode of action that distinguishes it from other current antiviral treatments for HSV infections and which should allow the compound to retain activity against viruses which have become resistant to marketed drugs. For two indications in parallel Pritelivir is being tested in patients to investigate its advantages over currently marketed herpes drugs. The first indication is the oral treatment of seriously ill patients suffering from genital herpes who do not respond to established herpes drugs, and the second – in an entirely different area – the treatment of labial herpes using a cream. After a successful clinical Phase 2 study and further analysis of clinical and preclinical results, Dr. Holger Zimmermann, CEO of AiCuris, is certain that Pritelivir can demonstrate its advantages in both labial and genital indications. “With the progress being made it is now time to talk to potential partners about the further development of this promising drug. The way forward is clear,” he explains.
The Company has also developed innovations in bacteriology. AIC499, for example, is a new, resistance-breaking and widely applicable, Gram-negative antibiotic that is due to enter clinical development later this year. The profile of AIC499, development of which is also being supported by the EU as part of a European Innovative Medicines Initiative (IMI) project, perfectly fits today’s medical needs. Zimmermann is convinced that he has a new contender with huge potential in the pipeline, and he wishes to pursue development with the IMI partners as soon as possible.
Another hot topic in today’s anti-invectives market is the development of a cure for hepatitis B (HBV) infections. Also here AiCuris is very active and has an innovative project already in clinical Phase 1. To further fill its pipeline, the Company is continuously supplementing its portfolio with early-stage projects in virology and bacteriology with a focus on HBV and adenovirus and Gram-negative bacteria respectively.
CEO Holger Zimmermann confidently commented on the Company’s future: “When hardly anyone has thought of resistance and anti-infectives, AiCuris has further focused its research intensely on this area. And we have already repeatedly demonstrated the efficacy of our products in patients.” Dr. Zimmermann is not surprised, then, that the topic has come to the public’s attention again. “The pharmaceutical sector has neglected this area for a long time and therewith “overslept” the problem – but these resistant pathogens, they never rest.”