FDA Okays Study of OSM-0205 to Prevent Chemo-Induced Peripheral Neuropathy

• An investigational new drug (IND) application was filed with the FDA for OSM-0205 in August 2023.

• No FDA-approved treatment options currently exist for patients with chemotherapy-induced peripheral neuropathy (CIPN).

• A phase 1 study will soon evaluate OSM-0205 to determine its safety, tolerability, and pharmacokinetics in patients with CIPN.

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The FDA has advised that the first-in-human trial of OSM-0205 in healthy individuals with CIPN may proceed, according to Osmol Therapeutics.¹

“Preventing CIPN would address a major women’s health issue for which there are currently no FDA-approved disease modifying treatment options,” said Arthur DeCillis, MD, chief medical officer of Osmol Therapeutics, in a press release. “OSM-0205 is administered intravenously immediately prior to chemotherapy treatment and has the potential to protect neurons in patients by preventing the surge in intracellular calcium associated with CIPN.”

OSM-0205 is designed to prevent the off-target calcium surge, which is generated by taxanes as well as other chemotherapy treatments that are linked with peripheral nerve damage, via a novel mechanism. The product is based on the research of Barbara Ehrlich, MD, at Yale School of Medicine, which focuses on neuronal calcium sensor-1 (NCS1).

OSM-0205 is administered intravenously and given immediately before chemotherapy treatment. The product can potentially protect neurons in patients by preventing the surge in intracellular calcium. Therefore, OSM-020 may improve the quality-of-life of patients with CIPN, as well as optimizing chemotherapy.²

In preclinical studies conducted by Osmol Therapeutics, pre-treatment with OSM-0205 has been shown to prevent the pathologic damage caused by potential chemotherapy agents. OSM-0205 works by blocking the calcium surge and is able to prevent calpain activation. Then, it maintains NCS1 and other proteins and protects neuronal integrity.

Previously in August 2023, the FDA received an IND for the agent as there are currently no FDA-approved therapies for patients with CIPN. Now, OSM-0205 will be evaluated in a phase 1 study for healthy subjects with CIPN, as well as a phase 2 study in patients with breast cancer.¹

“This first-in-human phase 1 clinical trial in healthy subjects will determine the safety, tolerability, and pharmacokinetics of single ascending doses of OSM-0205 intravenous infusion to select a dose to evaluate in phase 2 clinical studies in breast cancer patients,” added DeCillis.¹

REFERENCES

1. FDA notifies Osmol Therapeutics that the first-in-human phase 1 clinical trial of OSM-0205 for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) may proceed. News release. Osmol Therapeutics. September 18, 2023. Accessed September 19, 2023. https://tinyurl.com/mr3tp4w2

2. Technology. Osmol Therapeutics. Accessed September 19, 2023. https://tinyurl.com/mr386y54