Novella Clinical has snagged its first high-profile partnership since being bought by CRO giant Quintiles ($Q), teaming up with biotech Scioderm to manage a mid-stage trial of the company's rare skin disease treatment.
|Scioderm CEO Robert Ryan|
Scioderm--a member of FierceBiotech's 2013 Fierce 15--is developing SD-101 to treat epidermolysis bullosa, which leaves children with extremely fragile skin that easily tears and blisters, beginning at birth and often ending in an early death. In April, the FDA granted its much-coveted "breakthrough" designation to Scioderm's topical treatment, and now the biotech has Novella's expertise on board to manage a Phase IIb trial.
The partners expect to kick off enrollment in January, planning to study SD-101's safety and efficacy in 36 patients across the U.S., looking at a primary endpoint of target lesion closure at one month of treatment. Scioderm employs just 6 people, meaning it must be absolutely sure before picking a clinical partner, and company CEO Robert Ryan said Novella and its experience with small drug developers made it an ideal choice.
"Novella Clinical was a natural fit for this trial due to its therapeutic experience within dermatology and wound care, in addition to the company's commitment to emerging biotechs," Ryan said in a statement. "Novella offers the flexibility and transparency critical to Scioderm at this point in our development."
When Quintiles announced its deal for Novella back in August, the world's largest CRO said it wanted to keep the company's identity as an ally for small to mid-size biotechs intact, and Novella's latest partnership seems to fall right in line with that goal.
- read the announcement
Special Report: FierceBiotech's 2013 Fierce 15 - Scioderm