A Tony Coles Parkinson's biotech, Yumanity, continues its backslide as lead program earns a partial hold
A Tony Coles biotech looking to develop new drugs for Parkinson’s disease and other neurological conditions ran into trouble Wednesday as the FDA slapped its lead program with a partial clinical hold.
Yumanity will need to pause studies evaluating multi-dose administration of the drug, dubbed YTX-7739, in Parkinson’s, the biotech said. Though Yumanity did not elaborate on what exactly regulators took issue with, the FDA is allowing a planned study of a single dose to go ahead.
More details will be shared with Yumanity in the next 30 days, but until then the multi-dose study cannot begin enrolling patients. Shares of Yumanity $YMTX fell about 25% after Wednesday’s opening bell.
YTX-7739 is Yumanity’s only candidate to reach human studies since the company’s founding in 2014, and it’s also being studied in glioblastoma and other diseases. Parkinson’s is the lead indication, however, and the biotech has banked on a potential success here as a proof-of-concept for the whole platform.
Wednesday’s news comes about two months after Yumanity revealed some of the first data looking at whether the program could modify Parkinson’s disease progression. In a Phase Ib study, YTX-7739 failed to show any significant difference from placebo in most clinical measurements and exploratory biomarkers after 28 days, which the biotech said was expected.
The biotech also highlighted a smaller subset of patients on whom Yumanity conducted a quantitative electroencephalogram to measure brain activity, which the biotech said was statistically significant and might suggest possible effects on synaptic function. Yumanity further said the compound effectively inhibited its target, stearoyl-CoA desaturase, something the biotech has described as a potentially novel way to treat Parkinson’s and other diseases.
Investors, though, didn’t take that particularly well, shunning the stock and sending it down about 33% and toward penny stock territory at the time. Shares have only continued to spiral in the months since and Wednesday’s hold put Yumanity below the $2 mark for the first time.
The Phase Ib study in question only looked at a 20 mg single dose, and Yumanity previously said it expects to start a Phase II trial sometime this year.
The FDA hold marks an even deeper contrast between Yumanity and one of Coles’ other neurology biotechs in Cerevel Therapeutics, taking the remnants of Pfizer’s old neuroscience unit. Whereas investors have continued to show their disappointment in Yumanity, Cerevel has been on a sharp rise since a data reveal last June showed its schizophrenia program significantly lowered symptom severity compared to placebo.