The FDA issued the partial clinical hold order in response to the IND application Yumanity submitted in December last year. The company expects additional data on the directive within the next 30 days.
On Wednesday, Yumanity Therapeutics announced that it is temporarily holding its clinical trial for multidose testing of its proposed Parkinson’s disease drug YTX-7739 after the U.S. Food and Drug Administration told it to do so.
The FDA issued the partial clinical hold order in response to the Investigational New Drug (IND) application Yumanity submitted in December last year. The company expects additional data on the directive to be sent within the next 30 days.
YTX-7739 is its proprietary lead small molecule investigational treatment that works by penetrating the blood-brain barrier and inhibiting stearoyl-CoA desaturase (SCD). SCD appears to have a major role in mitigating neurotoxicity that eventually leads to the death of neurons, dysregulation of movements, and impaired cognition in person’s living with Parkinson’s disease.
In November last year, Yumanity posted positive results from its Phase IB clinical study on PD patients with mild-to-moderate diagnoses. In that trial, YTX-7739 was able to achieve its primary endpoints after 28 days of treatment and demonstrated only mild to moderate emergent adverse events and no serious adverse events. Its multiple dosing studies have so far been conducted in healthy volunteers for 14 days and 28 days, plus for 28 days in patients with Parkinson’s.
YTX-7739 is a potentially first-in-class drug with a disease-modifying mechanism of action. At present, there are no available treatments of this kind for Parkinson’s disease.
“Parkinson’s disease is a devastating neurodegenerative disease for which treatments address only temporary symptoms without any impact on the inevitable disease progression. To truly alter the course of the disease, we need new insights into the underlying cellular pathology and novel treatments that interfere with those processes,” commented Dr. Geert Jan Groeneveld, the chief scientific and medical officer at the Center for Human Drug Research in Leiden.
“The results of this trial are a very encouraging outcome and position YTX-7739 as potentially the first therapeutic candidate to test the lipidopathy hypothesis of synuclein,” added Dr. Groeneveld.
In reaction to the FDA’s latest hold order, Yumanity expressed confidence in its study and said it will work closely with the regulator to address all concerns adequately. In the meantime, the company said that it will continue with its planned trial for YTX-7739, which only covers a single dose.
Yumanity is also busy with the other programs in its pipeline, including potential treatments for multi-system atrophy, Lewy body dementia, Alzheimer’s disease and amyotrophic lateral sclerosis (ALS).
