Alfasigma S.p.A., a global pharmaceutical company, has entered into a strategic agreement with Innovative Molecules GmbH, a clinical stage biotechnology firm, to advance a new treatment option for Herpes Simplex Virus encephalitis. As part of the collaboration, Alfasigma will make an equity investment in Innovative Molecules and has secured exclusive worldwide rights to the injectable formulation of adibelivir, previously known as IM 250. The therapy is being developed to address HSV encephalitis, an ultra rare and life threatening neurological condition.
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Adibelivir is a next generation helicase primase inhibitor with multiple formulations under development. The oral version of the drug is progressing toward Phase two clinical studies for the treatment of genital herpes. The parenteral formulation, which is intended solely for HSV encephalitis, has received clearance to begin Phase one clinical development, marking an important step toward addressing a disease with very limited treatment options.
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HSV encephalitis is one of the most severe viral infections of the central nervous system. It carries a high risk of death and often leaves survivors with lasting neurological damage. Current antiviral treatments have been in use for decades, yet patient outcomes have not improved significantly, leaving a major gap in care. Adibelivir is designed as a long acting helicase inhibitor and is being studied for its ability to provide better viral control and potentially improve survival as well as long term neurological outcomes. Although the condition affects a relatively small population, estimated at roughly one case per 250,000 to 500,000 people, its clinical impact is devastating, reinforcing the need for new therapeutic approaches.
Francesco Balestrieri, Chief Executive Officer of Alfasigma, stated that the partnership aligns with the company’s focus on rare and specialty diseases. He explained that Alfasigma aims to grow by developing meaningful innovations that address complex medical challenges, supported by its global capabilities and experience. He described adibelivir as the type of breakthrough innovation that fits the company’s mission to improve outcomes for patients with serious unmet needs.
Florian Vogel, Chief Executive Officer of Innovative Molecules, shared that the agreement represents a strong endorsement of the company’s scientific strategy for treating HSV infections. He noted that partnering with Alfasigma not only validates the clinical potential of adibelivir but also provides critical funding to accelerate development. Vogel added that the investment will help advance the oral formulation of adibelivir into Phase two studies for patients with genital herpes.
Under the terms of the agreement, Alfasigma will hold exclusive global rights to develop, manufacture, and commercialize the injectable form of adibelivir for HSV encephalitis. Innovative Molecules will retain full ownership of all other formulations, including the oral version. The financial structure of the deal includes potential payments totaling up to 125 million euros, consisting of upfront and milestone based payments linked to development progress, regulatory achievements, and commercial success.
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