Medicus Pharma (NASDAQ:MDCX) earlier this week provided an update on its redesigned clinical study for Teverelix, reporting that the revised protocol had received Institutional Review Board approval and had been accepted by the US Food and Drug Administration subject to operational observations.
CEO Raza Bokhari told Proactive that the company had acquired the Teverelix development programme through its purchase of UK-based Antev. He described Teverelix® as a next-generation hormone antagonist being developed for two men’s health indications.
Proactive: We have spoken in the past about Teverelix and your discussions with the FDA and the Institutional Review Board about how to move the program forward. You have now received written responses from both, and the news appears to be very positive. Are you on the right track?
Bokhari: We very much are. We have had a good day at Medicus Pharma (NASDAQ:MDCX).
For the benefit of your viewers, towards the end of last summer, we added a second asset to our portfolio through the acquisition of a UK-based company called Antev. Through that acquisition, we took over the clinical development programme for Teverelix, a next-generation hormone antagonist.
We are pursuing two indications in men’s health: one involving patients with advanced prostate cancer and a high cardiovascular risk profile, and another involving a novel study designed to prevent the relapse of acute urinary retention, primarily due to an enlarged prostate.
The second study inherited from Antev was designed to include 390 patients across multiple centres in Europe and the United States. It carried an estimated cost of more than $30 million.
Our research and development team reviewed the study and believed there was room to redesign and optimize the protocol while reducing the burden on patients. The redesigned protocol reduced the patient requirement from 390 to 126, representing a reduction of approximately 68%, while preserving scientific rigour.
The FDA agreed with us. The study has therefore become more cost-efficient while remaining a decision-grade study. We believe it could now cost less than $10 million.
The revised design also allows us to conduct an interim analysis to assess whether we are moving in the right direction. In novel studies, it is important to have inflection points that allow us to evaluate progress. This is a very positive outcome for us.
Proactive: We should confirm that the feedback from the FDA and the Institutional Review Board focused more on certain operational elements of the study rather than the core study design. It included matters such as demographic data and ensuring the correct documentation was in place. Is that accurate?
That is correct. The Institutional Review Board has approved the protocol. It has signed off on the protocol amendments, the optimized design and the changes we have made.
The FDA has provided observations that are operational in nature. There can always be concerns when a proof-of-concept study has already been reviewed by the FDA and a company returns to redesign it before patient recruitment begins, as that can potentially lead to a negative response.
We have been very fortunate that the FDA accepted the revised design while providing observations that are operational in nature. We will incorporate the additional points advised by the FDA.
We are now on track, and the company will provide an update when patient recruitment begins. We still have work to complete relating to chemistry, manufacturing and controls so that the product is available, as well as work to activate the clinical sites.
There is still a lot of work ahead of us, but it is becoming more efficient and streamlined. We are very excited that we are making good progress.
Quotes have been lightly edited for style and clarity