FDA grants fast track status to oral therapy for hard-to-treat myeloma
Opna's OPN-6602 designed for patients already given at least 4 treatments
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The U.S. Food and Drug Administration (FDA) has granted fast track status to Opna Bio‘s OPN-6602 as a potential treatment for people with multiple myeloma that has come back or failed to respond following at least four prior lines of therapy.
The new designation was announced by the drug’s developer, which noted in a company press release that “despite therapeutic advances, most [myeloma] patients ultimately relapse or become refractory [resistant] to available therapies, highlighting an unmet need for novel treatment options.”
The FDA awards fast track status to experimental treatments that have the potential to address unmet needs in the care of serious conditions, with the goal of speeding up the development of important new medicines. With this designation, Opna Bio will have access to perks such as more frequent feedback from the FDA during the drug development process.
Myeloma is a type of blood cancer in which plasma cells, a type of immune cell, grow out of control in the bone marrow. These cancerous cells usually are found in more than one marrow, hence the term multiple myeloma. OPN-6602 is an oral therapy designed to inhibit two proteins, EP300 and CBP, both of which are thought to play a role in the abnormal growth of myeloma cells.
“Opna Bio has been a pioneer in the EP300/CBP inhibitor space and OPN-6602 was selected for its potency, selectivity, and optimized pharmacokinetic properties,” said Reinaldo Diaz, Opna’s CEO. Pharmacokinetics refers to how a drug moves into, through, and out of the body.
OPN-6602 now being tested in US clinical trial
Opna is sponsoring a Phase 1 clinical trial (NCT06433947) that’s testing OPN-6602 in people with myeloma who have failed to adequately respond to at least three previous lines of therapy, including an immunomodulator, a proteasome inhibitor, and a CD38 inhibitor.
The study’s main goal is to evaluate the safety of OPN-6602. The trial is now enrolling adults at several sites in the U.S.
Participants in the trial are treated with OPN-6602 at various doses; some will receive the experimental therapy only, while others will get OPN-6602 in combination with dexamethasone, a steroid medication commonly used as part of myeloma treatment.
“We are encouraged by the progress of the study to date and look forward to reporting emerging clinical data at an upcoming scientific congress,” Diaz said.
This new FDA designation comes barely a year after the agency granted OPN-6602 orphan drug status. That designation, given to experimental therapies aimed at treating rare diseases, offers developers additional incentives to invest in treatments for conditions affecting fewer than 200,000 people nationwide. Among its perks are seven years market exclusivity should the drug ultimately be approved.
