It looks like Ampio Pharmaceuticals’ last shot at getting a therapy to market won’t even make it into the clinic. Animal studies have shown that the Colorado biotech’s OA-201 program was unable to reduce pain caused by osteoarthritis.
The small molecule formulation had shown promise in smaller preclinical studies when its ability to reduce pain and preserve knee cartilage was compared to saline. However, that same benefit has not been reproduced in a recent set of larger preclinical animal studies, the biotech admitted in a post-market release yesterday.
"We believe we need to demonstrate a statistically significant improvement in both pain reduction and cartilage protection to support the IND and justify the capital necessary to complete the planned phase 1/2 trial,” Michael Martino said in the release.
“The data from the larger nonclinical pain reduction trial simply do not support the same pain reduction benefit as was demonstrated in the earlier, smaller, proof-of-concept trials," the CEO added.
That means the company’s plans to file for an investigational new drug application next year are out the window, and with it Ampio’s last ditch effort to develop a product.
The biotech has seen its clinical options reduced in recent years, starting in 2018 when the FDA ruled that a trial for the company’s osteoarthritis drug Ampion fell short of standards. Ampio moved to run another phase 3 study, which was later ravaged by the COVID-19 pandemic, resulting in missing data that the FDA also nixed. The company’s attempts to develop the drug to address COVID-19 also failed, leading Ampio to lay off all but five employees by early 2023.
What would become known as OA-201 is a formulation of three of the ingredients found in Ampion, although Martino has stressed to shareholders that it is a different drug.
With the pipeline now completely empty of both Ampion and OA-201, Ampio's management and board are “currently assessing both internal and external options.”
“The company will be taking immediate actions to preserve its cash in order to be able to adequately fund any option identified by the board,” it added.