Capricor's DMD clinical trial meets primary endpoints; Delaware court rules against Takeda in Lupron feud
Beverly Hills, CA-based biotech Capricor Therapeutics revealed today final data from its clinical trial evaluating stem cell therapy CAP-1002 for patients in advanced stages of Duchenne muscular dystrophy.
Duchenne is a rare muscle-wasting disease caused by the absence of dystrophin, a protein that helps keep muscle cells intact. It disproportionately affects boys — and as of last year, affects roughly 6,000 in the United States.
According to a Capricor statement, the HOPE-2 clinical trial met its primary efficacy endpoint of upper limb performance, as well as various skeletal and cardiac endpoints suggesting slowing of disease progression.
The randomized, double-blinded, placebo-controlled Phase II clinical trial of CAP-1002 was conducted at nine locations across the US with no serious safety signals identified, with the exception of two hypersensitivity reactions early on.
“Now that we have clarity from the FDA and based on the strength of this data set, we are poised to embark on the HOPE-3 pivotal trial once we have secured an appropriate partner that can help drive CAP-1002 forward towards commercialization,” said Capricor CEO Linda Marbán in a statement.
Equity court rules Takeda breached contract with AbbVie on prostate cancer drug
A Delaware judge has issued a separate ruling in favor of AbbVie in the pharma giant’s spat with Takeda, two weeks after siding with its Lupron partner.
In the latest ruling, the judge found Takeda guilty of breach of contract for failing to supply AbbVie with the prostate cancer drug under their prior deal. Two weeks ago, the judge ruled that the Delaware Court of Chancery, where the case was heard, didn’t have the jurisdiction to order Takeda to live up to its supply agreement.
AbbVie had claimed that Takeda is responsible for supply chain problems that have led to worldwide shortages of Lupron, a hormone drug that has been used to treat prostate cancer. While AbbVie both developed the medicine and distributes it in the US and Canada, Takeda is the drug’s only manufacturer, supplying it from its Hikari, Japan plant.
Lupron has been in short supply worldwide since the company and the FDA discovered “significant violations” at the plant in November 2019. The judge told the companies that another trial is needed to determine the extent of the damages caused by Takeda.