Science Translational Medicine Publication: Innovative

– IM-250 reduces viral load, virus shedding and the rate of recurrence

– Potential treatment for persistent, neurotrophic herpes simplex

Munich, Germany, June 16, 2021 – Innovative Molecules GmbH, a drug development company focused on developing next generation treatments for herpes simplex-induced diseases, today announced preclinical data demonstrating that the company’s drug candidate IM-250 carries both acute and chronic infections the neural herpes simplex virus (HSV) in mice and guinea pigs. IM-250 is a proprietary, novel helicase primase inhibitor. The study, entitled “A Helicase-Primase Drug Candidate With Adequate Target Tissue Exposure Affects Latent Herpes Simplex Neural Virus Infections,” was conducted by a team of researchers from the United States and Germany and published today in Science Translational Medicine.

In various animal models of HSV, IM-250 demonstrated potent anti-herpes activity, a novel mechanism of action, a low incidence of HSV resistance, and a favorable pharmacokinetic and safety profile. IM-250 has no off-target activity seen with other anti-HSV drugs and has no potential metabolites of previous drug candidates that target helicase-primase. It results in improved exposure of the target tissue, especially in neurons, and shows superior effectiveness in the prevention and treatment of HSV infections and diseases in animal models compared to standard treatment. Notably, the compound not only reduces the duration of symptoms and the time to recovery, but also reduces the incidence of relapses and virus shedding.

“IM-250 has clear advantages over standard therapies and is a promising therapeutic agent for chronic HSV infections, including nucleoside-resistant herpes simplex,” said Prof. Dr. Gerald Kleymann, CEO and founder of Innovative Molecules, and senior author of the degree. “The most prominent observation is its ability to mitigate recurring infections, and based on our preliminary results, it is hoped that it will make neurotrophic herpes simplex virus infections treatable – even if they have lifelong latency after a primary infection. To the best of our knowledge, this has not yet been observed with any anti-HSV agent. “

In the study, intermittent monotherapy with IM-250 or combination therapy with IM-250 and valaciclovir (VAVC) as standard therapy resulted in a statistically significant reduction in both the cumulative relapse score compared to placebo and in HSV-2 excretion outside of the Treatment period. The decrease in the frequency of virus shedding was associated with a decrease in the cumulative mean viral load. Overall, the study observed a statistically significant increase in disease-free animals compared to placebo, both during and outside of therapy, from the first treatment cycle.

“IM-250 has the potential to overcome significant limitations in current HSV therapies for resistance, recurrent viral shedding and disease, and severe CNS or disseminated disease,” said David I. Bernstein, infectious disease specialist at Cincinnati Children’s Hospital Medical Center OH) and co-author of the study. “Our results also challenge the traditional belief that herpes simplex disease is not effectively treatable. Although we do not yet understand how the drug affects latency or reactivation after stopping treatment, we believe that using the drug during infection may decrease or inactivate latent DNA in neurons, or decrease the number of latently infected ones Cells leads neurons. “


About herpes simplex infection and disease
Herpes simplex disease is a contagious, lifelong infection with high incidence and prevalence data, a quiet pandemic with an enormous health burden, and a risk factor for contracting HIV, HPV and Alzheimer’s disease. At least 50% of the population are infected with the herpes simplex virus type 1 (HSV-1), mostly herpes labialis, while approx. 25% of the population are infected with the herpes simplex virus type 2 (HSV-2), mostly genital herpes, a sexually transmitted infection / disease. Lifelong latency is established by the deposition of HSV episomal DNA in sensory neurons. In response to various stimuli, HSV reactivates from the latent reservoir, causing recurrent herpes disease. Up to 30% of patients suffer from frequent relapses, which in immunocompromised patients can be painful, socially isolating and even life-threatening. There is currently no treatment that is capable of reducing or eradicating the virus reservoir as such.

About innovative molecules
Innovative Molecules GmbH is a drug development company with the aim of setting a new standard of treatment for herpes simplex-induced diseases. The company is focused on the development of IM-250, a potent helicase-primase inhibitor of the second generation of HSV-1 and HSV-2. Because of its potency, excellent neural tissue exposure, and long half-life, IM-250 has the potential to change the way herpes simplex-induced diseases are treated. Preclinical data suggest that IM-250 not only blocks active virus replication, but may also reduce or even wipe out the viral reservoir, ultimately leading to fewer relapses or even a cure for this latent, lifelong infection.
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