In a recent podcast, Promedior CEO Jason Lettmann was interviewed about PRM-151, his company’s experimental drug treatment for IPF and other scarring diseases.
SOUNDCLOUD- GLOBAL GENES
In an August 1, 2019 podcast by Global Genes, a non-profit corporation advocating for rare diseases globally, host Daniel Levine interviewed Promedior CEO Jason Lettmann about PRM-151, his firm’s experimental IPF treatment.* The Lexington, MA-based Promedior believes its novel drug therapy may not only stop the lung disease but reverse it.
The first 14 minutes of the 20-minute podcast were devoted to PRM-151 for IPF, with the remaining time centered on treatment of other scarring diseases like myelofibrosis (scar formation in bone marrow).
While the only two currently approved drugs (Esbriet®/pirfenidone and OFEV®/nintedanib) can help slow rate of decline in forced vital capacity/FVC (the maximum amount of air able to be exhaled after the deepest breath), they cannot stop the disease from progressing “or really improve any objective measures.” They also can have serious side effects that can affect medication adherence.
Promedior’s answer to this unmet need, PRM-151, is an engineered form of plasma-derived pentraxin 2 protein (PTX2). The naturally occurring human protein acts as a kind of antibody that prevents scar formation while clearing existing scarring and damaged tissue. Research shows reduced levels of PTX2 in people with scarring diseases like PF, with a strong link to such diseases.
PTX2, explains Lettmann, binds to damaged tissue and to white blood cells (monocytes, for example) to help activate these cells against scarring.
A single dose of PRM-151 has a long-lasting effect (weeks after ingestion), since it promotes healing at the site of tissue injury/scarring.
Compared to currently approved drugs, PRM-151 has shown a favorable safety profile with no dose-limiting toxicity on 250 patients thus far (some beyond five years). This was seen in a recent open-label extension study in The Lancet Respiratory Medicine.
In Phase 2 research published in JAMA, the test drug resulted in significantly less decline of FVC and six-minute walk test (6MWT) distance versus placebo (standard of care). Lettmann noted that significant change in the 6MWT was “a tough endpoint to hit.”
The company has been working with the US Food and Drug Administration on design of Phase 3 study for registration and has been given “a clear path forward,” hoping to initiate this phase in early 2020.
In March of 2019, the company received “Breakthrough Designation” from the FDA—only the third IPF drug since pirfenidone and nintedanib to receive this label.
The podcast can be heard at:
*Global Genes. (2019, August 1). Seeking to Halt and Reverse Fibrotic Diseases. SoundCloud.