Rebounding from a disappointing IPO, Israel's NeuroDerm ($NDRM) watched its shares more than double on promising results from a small study of its Parkinson's disease treatments.
NeuroDerm's two products are drug-device combos designed to subcutaneously mete out high and low doses of the Parkinson's treatments levodopa and carbidopa. In a 16-patient trial, the company's candidates were safe and well-tolerated, charting a consistent dose-dependent effect on levodopa levels, NeuroDerm said.
Oral formulations of levodopa and carbidopa have particularly short half-lives, the company said, requiring patients to take multiple pills per day and often leading to unpleasant fluctuations in plasma levels. In the Phase IIa study, NeuroDerm's treatments led to "markedly" more consistent levodopa levels than quick-release tablets, according to the company. And the high-dose version spurred levodopa concentrations to date only reached through invasive procedures, NeuroDerm said, suggesting it could replace the surgically inserted pumps prescribed for the most severe Parkinson's patients.
"These results add to the growing body of clinical data confirming our thesis that continuous, subcutaneous delivery of LD/CD leads to more consistent therapy, which we expect to have a dramatic effect on patient outcomes and quality of life, replacing in most cases the need for surgical intervention," CEO Oded Lieberman said in a statement.
The plan now is to roll both products, ND0612L and ND0612H, into Phase III studies next year, and NeuroDerm has said it expects to win U.S. and European approvals by 2018.
The news sent NeuroDerm's shares up more than 100% on Tuesday, rocketing the biotech's stock price to around $18 and, for the first time, above its $10 IPO value. The company went public in November after taking a deep discount from its expected range of $13 to $16 a share, and its share value only floundered from there, hitting a $6 nadir earlier this month.
Beyond its two lead candidates, NeuroDerm's pipeline includes ND0680, a Phase I technology that delivers even higher doses of levodopa and carbidopa for severe Parkinson's patients, and the preclinical ND0701, which administers apomorphine for patients unable to handle the two-drug combination. The company is also working on ND0801, a Phase II treatment that combines nicotine and opipramol to treat cognitive disorders.
- read the statement