Acorda Therapeutics ($ACOR) moved a step closer to collecting the payoff from its $525 million acquisition of Civitas, maker of an inhaled levodopa, in the scramble to deliver an improved formulation of the standard Parkinson's med. The conventional oral formulation suffers from unpredictable absorption in the bloodstream and a wearing-off effect after about 5 years.
In a Phase IIb trial, Acorda's CVT-301 outperformed placebo in Parkinson's patients experiencing debilitating off episodes that restrict movement, the company announced at an international Parkinson's conference in San Diego, CA, pushing its stock up 3.5%. And the improvement was apparent 10 minutes after administration via inhaler and the candidate's effect lasts for at least an hour.
The trial subjects were given 35 mg of CVT-301 or inhaled placebo in weeks one and two, and 50 mg of either in weeks 3 and 4. The primary endpoint was the mean change from baseline in Unified Parkinson's Disease Rating Scale Part 3 score (10-60 minutes postdose) after 4 weeks of treatment. UPDRS III is an established scale for measuring motor impairment in Parkinson's patients.
There were no serious adverse events or incidences of dyskinesia (involuntary muscle movements) during on periods, another side effect of oral levodopa.
"Oral levodopa, or L-dopa, is the current gold standard of care for Parkinson's disease. However, as the disease progresses, the majority of people will experience off episodes, even while on L-dopa therapy," said Acorda Chief Medical Officer Dr. Enrique Carrazana in a statement. "Based on the successful results of this study, we have initiated a Phase III clinical and a long-term safety trial to further assess the potential of CVT-301 to reduce the duration of off episodes in people taking oral L-dopa. We believe that if successful, these results, together with the existing Phase IIb data, will enable Acorda to file a New Drug Application with the FDA."
Civitas nailed down a substantial $55 million venture round in August aimed at getting its lead program for Parkinson's through Phase III and onto the market.
New investors Adage Capital Management, OrbiMed Advisors, Partner Fund Management, Rock Springs Capital, and Sofinnova Ventures all stepped in, along with strategic investor Alkermes and a bevy of previous VC investors.
While the results of its latest trial are promising, Acorda is likely to face a plethora of competitors in the reformulated levodopa space.
The FDA has already approved AbbVie's ($ABBV) novel formulation of levodopa, Duopa, which is delivered straight into the patient's small intestine over 16 consecutive hours using an infusion pump and a procedurally placed tube.
Others in the race to market include Neuroderm's ($NDRM) wearable pumps for subcutaneous delivery, Intec Pharma's drug-delivering accordion pill, and Bioties' oral supplement to levodopa.
In addition, Cynapsus is developing a noninjectable version of second-line Parkinson's med apomorphine.
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