Medicus Pharma (NASDAQ:MDCX) CEO Dr. Raza Bokhari talked with Proactive about the company’s newly reported topline Phase 2 results for its microneedle array patch technology targeting basal cell carcinoma, a common form of non-melanoma skin cancer.
Bokhari explained that the study represents a proof-of-concept Phase 2 trial using the company’s patented microneedle arrays developed from research at Carnegie Mellon University and the University of Pittsburgh.
The technology is designed as a non-invasive treatment approach for skin cancers, aiming to provide an alternative to more traditional surgical interventions.
According to Bokhari, the topline findings were encouraging, particularly in the 200 microgram cohort, where the study demonstrated 73% clinical clearance and more than 40% histological clearance or complete response.
He described the data as “positive and decision grade,” meaning it is strong enough to inform both regulatory discussions and strategic business decisions.
Bokhari noted that the results support the company’s strategy of advancing therapies through Phase 2 proof-of-concept studies before partnering with larger pharmaceutical companies for late-stage development and commercialization.
He added that the dataset could accelerate ongoing partnering discussions and potentially lead to a monetizing event for the company.
The data will also support an end-of-Phase-2 meeting with the US Food and Drug Administration, where Medicus Pharma plans to discuss the design of a potential pivotal trial focusing on the 200 microgram patch and treatment timeline.
Proactive: Welcome back inside our Proactive newsroom. Joining me now is Dr. Raza Bokhari, CEO of Medicus Pharma. Dr. Bokhari, good to see you again. How are you?
Raza Bokhari: Thank you so much, for having me back on your program.
Exciting news after the company reported positive Phase 2 results. These are topline results from your Phase 2 study. Remind everyone about the study and what it was designed to do.
We are very excited to share the topline findings of our Phase 2 proof-of-concept study. The trial evaluates our uniquely designed, patent-protected microneedle arrays developed at Carnegie Mellon University and the University of Pittsburgh. Our focus is on bringing a novel non-invasive treatment to market for non-melanoma skin diseases, particularly basal cell carcinoma.
The findings demonstrate that the microneedle arrays work, especially in the 200 microgram cohort. In that group we observed 73% clinical clearance and more than 40% histological clearance, or complete response, which by any measure is positive and decision-grade data.
Can you talk about what you mean by “decision-grade” data?
Medicus Pharma’s strategy is to pursue select Phase 2 studies, achieve proof of concept, and then position those programs for partnerships with larger pharmaceutical companies that can handle late-stage development and commercialization.
This dataset is decision-grade because it gives us adequate data to accelerate ongoing partnering discussions. The data may be strong enough for a partner to take the baton from us, potentially leading to a monetizing event.
From a regulatory standpoint, the data also supports an already planned end-of-Phase-2 meeting with the FDA to finalize the design of a pivotal study.
There will also be more data coming out beyond these topline results?
Yes. The clinical study report will provide additional datasets, particularly around safety, which we believe is very strong. There will also be more detailed pathology findings about biological activity.
However, we do not believe those additional details will materially change the outcome presented in the topline results.
And the next key step is the meeting with the FDA?
The next logical step is twofold: preparing for the end-of-Phase-2 meeting with the FDA and advancing discussions with a strategic partner who could take the baton forward.
Quotes have been lightly edited for style and clarity