Monopar Therapeutics Stock Jumps 4X, Inks Licensing Pact With AstraZeneca For Once Terminated Phase 3 Candidate For Rare Genetic Disorder

Monopar Therapeutics Inc. MNPR stock is skyrocketing on Thursday.

The company agreed with AstraZeneca Plc’s AZN Alexion for an exclusive worldwide license to ALXN-1840 (bis-choline tetrathiomolybdate) for Wilson’s disease.

Monopar will be responsible for all future global development and commercialization activities.

Also Read: Why Monopar Therapeutics (MNPR) Stock Is Skyrocketing Today

Under the terms of the license agreement, Monopar will pay Alexion an upfront cash payment and equity in Monopar. Future payments are based on tiered royalties on net sales and pre-determined regulatory and sales milestones.

Wilson disease is a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised. It affects one in 30,000 live births in the U.S.

Over time, the condition results in the build-up of toxic copper levels in the liver, brain, and other organs.

In April 2023, AstraZeneca decided to terminate its ALXN1840 program as additional studies done to confirm the ALXN1840 mechanism of action did not achieve their endpoints, and they do not see a path forward to achieve approval from the FDA or European Medicines Agency.

The company’s decision was based on feedback from regulators on the review of data from the Wilson Disease program, including the Phase 3 FoCus and two Phase 2 mechanistic trials.

In June 2022, the company shared detailed results from the FoCus Phase 3 trial of ALXN1840.

The study met its primary endpoint, demonstrating three times greater copper mobilization from tissues compared to the standard of care (SoC) arm, including in patients treated previously for an average of 10 years. Topline data was shared in August 2021.

In the trial, people taking ALXN1840 experienced rapid copper mobilization, with a response at four weeks and sustained through 48 weeks.

In patients who were symptomatic at baseline, neurological scores improved more for those treated with ALXN1840 than for those treated with SoC. However, no significant differences between treatment groups were observed at 48 weeks.

The company added that most patients in the trial had low symptom scores at baseline, so there was minimal room for total score improvement.

Price Action: MNPR stock is up 410.6% at $23.64 at last check Thursday.

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