Yumanity: Partial Clinical Hold by FDA on Multidose Trials

 Yumanity Therapeutics (Nasdaq: YMTX), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative, disease-modifying therapies for neurodegenerative disease, today announced that, in response to its IND application submitted in December 2021, it was notified via email by the U.S. Food and Drug Administration (FDA) that the FDA has placed a partial clinical hold on multidose clinical trials of YTX-7739, currently being developed for the treatment of Parkinson’s disease. The FDA has not halted all clinical programming and is permitting the Company’s planned single dose clinical trial to proceed. The partial clinical hold suspends initiation of multiple dose clinical trials in the U.S. until the FDA’s questions have been addressed.

The Company expects to receive additional detail from the FDA within the next 30 days. Yumanity anticipates working closely with the FDA to adequately address their concerns.

About YTX-7739
The Company is assessing the potential utility of YTX-7739 as a disease modifying therapy for Parkinson’s disease and has previously reported results from 14 day and 28 day multiple dosing studies in healthy volunteers and a 28 day multiple dose clinical study in patients with Parkinson’s disease.

YTX-7739 is Yumanity Therapeutics’ proprietary lead small molecule investigational therapy designed to penetrate the blood-brain barrier and inhibit the activity of a novel target, stearoyl-CoA desaturase (SCD). SCD appears to play an important and previously unrecognized role in mitigating neurotoxicity arising from the effects of pathogenic alpha-synuclein protein aggregation and accumulation, which ultimately results in the death of neurons and the subsequent dysregulation of movement and cognition that afflicts patients living with these diseases. Through inhibition of SCD, YTX-7739 modulates an upstream process in the alpha-synuclein pathological cascade and has been shown to rescue or prevent toxicity in preclinical cellular and animal models.

https://finance.yahoo.com/news/yumanity-reports-partial-clinical-hold-123000297.html