The double-blind, randomised, placebo-controlled trial will assess the safety, efficacy, and tolerability of buntanetap in PD patients.
Nearly 450 subjects with early PD will be enrolled in the trial to receive either 10mg or 20mg buntanetap, or a placebo, along with the standard of care for six months.
The trial’s primary endpoints will be Movement Disorder Society-Sponsored Revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part II and III.
The secondary endpoints will include total MDS-UPDRS and Participant Global Impression of Change.
Plasma biomarkers, the Wechsler Adult Intelligence Scale, and Mini-Mental State Examination will also be analysed as the trial’s exploratory endpoints.
An oral translational neurotoxic aggregating proteins (TINAPs) inhibitor, buntanetap (ANVS401 or Posiphen) is said to reduce neurotoxic protein levels. This approach will subsequently offer reduced toxicity in the brain.
Annovis Bio founder, president, and CEO Maria Maccecchini said: “Buntanetap has shown promising preliminary safety data in all clinical work to date.
“Just as encouraging is the significant improvement in speed of movement, motor function, and cognitive function observed in early to moderate PD patients treated with buntanetap in the Phase IIa trial.”
According to the findings from a Phase IIa trial in PD patients, a 5mg, 10mg, 20mg, 40mg, or 80mg daily dose of buntanetap was not linked to any clinically relevant adverse events.
Buntanetap also offered a statistically significant improvement in motor function.
It was found to be safe and well-tolerated in the trial, with pharmacokinetics consistent with those seen priorly in humans.
In July this year, the company obtained notice from the US Food and Drug Administration to proceed with the Phase III trial of buntanetap for early PD.