Rockwell Medical Technologies Inc. saw its stock lose about a quarter of its value in early trading Friday, after the company announced its iron deficiency anemia drug failed to meet its efficacy goal in a clinical trial.
A Phase 2b study of the drug, Soluble Ferric Pyrophosphate, showed that it didn’t meet its endpoint of adequately reducing hemoglobin levels in chronic hemodialysis patients, according to a statement from the Michigan biotech firm.
The trial wasn’t all bad news for Rockwell, however, as the drug successfully met its safety endpoint. Further, it accomplished its objective of determining proper dosing for upcoming trials. Despite the failure, Rockwell plans to begin a Phase 3 trial in the third quarter.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
“The study was successful in providing safety and efficacy data for the determination of dosing and optimal Phase 3 study design, giving us a clear pathway for initiating Phase 3 trials in the second half of 2010,” said Dr. Richard Yocum, Rockwell’s vice president of drug development.
But it was the efficacy failure that caught investors’ attention, sending Rockwell’s share price tumbling as low as $5.83 Friday, down from its $8.14 close the prior day. The share price had rebounded somewhat to $6.25 in late morning trading.
SFP, the company’s lead investigational drug, aims to deliver iron directly to the bloodstream then transfer its iron load at the cellular level. Rockwell is working to develop drugs that would treat end-stage renal disease, chronic kidney disease and iron deficiency anemia. It also plans to use its SFP technology to develop drugs in the areas of women’s health, oncology and parenteral nutrition.
In October, the company raised $22 million via a direct offering of its shares. The company has not yet reported its full-year 2009 financial information. Through the first three quarters of last year, it lost $5 million on revenue of $40 million.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Rockwell was founded in 1995 and went public on the Nasdaq stock exchange three years later.
