Medicus Pharma (NASDAQ:MDCX) CEO Raza Bokhari talked with Proactive about the FDA's clearance to begin a Phase 2b dose optimization study for Teverelix, the company’s next-generation GnRH antagonist targeting advanced prostate cancer.
Proactive: All right. Welcome back inside our Proactive newsroom. And joining me now is Dr Raza Bokhari. He is the CEO of Medicus Pharma. Dr Bokhari, good to see you again. How are you?
Raza Bokhari: Thank you for having me back on your program.
Yes. Excited to have you here, especially because you've got significant news out that you've now been cleared to launch a Phase 2b study for Teverelix. So let's talk about Teverelix first. You're looking at this potentially for prostate cancer.
That is correct. As we have shared with your audience, we have entered 2026 with multiple Phase 2 catalysts. This is one of the most exciting news items for us, where the FDA has given us a study may proceed notice, allowing us to commence a dose optimization study for Teverelix.
Our asset comes to us following the acquisition of Antev. This dose optimization study sets the stage for us to subsequently begin a pivotal study for patients with advanced prostate cancer and high cardiovascular risk profiles.
Tell me about Teverelix and what it is designed to do.
Teverelix is a next-generation GnRH antagonist. It is an androgen deprivation therapy administered as an injectable that suppresses the LH and FSH hormones, resulting in testosterone suppression, which is very important to prevent progression of advanced prostate cancer.
In patients with advanced prostate cancer—approximately 300,000 to 500,000 in the United States living on androgen deprivation therapy—the most common cause of death is not prostate cancer, but cardiovascular comorbidity. Teverelix®, as an antagonist rather than an agonist, has an opportunity to achieve a label indication if we can demonstrate that it is also cardioprotective. We hope this could become a first-in-class indication.
You're looking to enroll about 40 men for approximately 22 weeks. Is this something you want to get started on right away?
We are aligning our CMC and manufacturing. We have retained IQVIA as our CRO. This dose optimization study is designed to ensure we can maintain castration levels beyond day 42, which was demonstrated in the previous Phase 2a study.
This Phase 2b study extends evaluation to day 155, positioning us to return to the FDA to finalize a pivotal study. Our focus as a company is on completing Phase 2 studies and positioning the asset for partnership and monetization.
Besides the Skinject opportunity, which is ready for monetization pending data readout, we believe Teverelix could become a partnership candidate around this time next year.
Quotes have been lightly edited for style and clarity