Knopp Neurosciences Inc. licensed Dexpramipexole (Dex) to Biogen Idec in 2010 after the compound (formerly known as KNS-760704) showed promising Phase II clinical results in people with ALS. In 2011, Biogen and Knopp began enrolling ALS patients in the Phase III Dex trial, which was intended to evaluate the safety, efficacy, and pharmacokinetics of Dex. This past January, Biogen Idec announced that their Phase III clinical trial of Dex in over 900 people with ALS failed to meet its primary and secondary endpoints for function and survival, and Biogen decided to discontinue the development of the drug.
However, Knopp isn’t ready to shelve Dex. Knopp cofounder Tom Petzinger said “We want the opportunity to continue developing this drug for ALS.” In order to effectively move forward with developing Dex, Knopp wants the blood samples from the patients that took part in the trial as well as the regulatory data that was generated from the trial. Although Biogen argues that they “don’t have an obligation under the licensing deal to transfer that data,” Knopp is leaving this decision up to the US District Court in Boston. Stay tuned to the ALS e-Newsletter to find out what the courts decide.
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