In an exclusive interview with The Fly, Altamira Therapeutics (CYTO) CEO Thomas Meyer talked about the company, its new RNA focus, ongoing clinical trials, pandemic-related impacts on the company and much more.
COVAMID CLINICAL INVESTIGATION: Altamira Therapeutics is dedicated to developing therapeutics that address important unmet medical needs. The company is currently active in RNA therapeutics, allergy and viral infections, and inner ear disorders.
Last week, Altamira Therapeutics announced that it had completed the pre-specified blinded interim sample size analysis in the COVAMID trial to evaluate its Bentrio nasal spray in patients with acute COVID-19. The company has resumed enrollment to increase the size of the study population from the current 136 to a total of 160 subjects. "It shouldn't take long to enroll patients," with "topline data moving to Q4," Meyer explained to The Fly.
The interim analysis showed that the actual standard deviation of the primary efficacy outcome measure was somewhat higher than what had initially been assumed for the statistical powering of the study. COVAMID is a randomized, placebo controlled clinical trial to evaluate the safety, tolerability, and efficacy of Bentrio. The primary efficacy endpoint will be the mean cycle threshold improvement in the customary RT-PCR test for COVID-19, i.e. the reduction of the SARS-CoV-2 load based on upper or middle throat swab samples. In the COVAMID trial, patients are randomized at a 2:1:1 ratio to receive for 10 days either Bentrio, a placebo, or no treatment, followed by a 10-day observation phase. COVAMID is being conducted in Bulgaria and North Macedonia.
OLIGOPHORE, SEMAPHORE TECHNOLOGY: Altamira believes RNA-based therapies are currently one of the most promising fields in medical research. However, effective and robust nucleic acid delivery remains the key rate-limiting step for unlocking the full potential of RNA therapeutics. The company OligoPhore/SemaPhore technology is a highly versatile platform that allows for effective and safe delivery of nucleic acids into cells, notably into non-liver tissues, using systemic or local administration. "When we came across this technology last year it sounded almost too good to be true," the executive said.
"What’s important here is we can deliver RNA to other tissues other than the liver. Typically, there’s technology that’s pretty good, works very well taking RNA to the liver. If you have a target, a disease inside the liver or where it plays a roll then fantastic. But if you want to target something else, for example pancreatic cancer or lung cancer, then you don’t want to see your RNA go to the liver. You want to see it go to that cancer and deliver RNA there. This is what we can achieve with this technology. Once inside the cell, we have a very significant release of RNA. Existing technology is only releasing 1% or 2% of RNA inside the cell. Here we have complete or almost complete release. This is a big differentiator," Meyer added.
LEGACY PROGRAMS: The company is also developing betahistine for intranasal treatment of vertigo under project code AM-125 and currently in Phase 2 of clinical development; Keyzilen, or AM-101, for the treatment of acute inner ear tinnitus; and Sonsuvi, or AM-111, for the treatment of acute inner ear hearing loss, with these last two programs in Phase 3 of clinical development and designated for partnering to move to the next studies.
"Our company wants to focus going forward on RNA because we see here a clear strong potential. Our existent programs – the legacy programs – have been very exciting but we found that it was difficult to attract interest and attention of investors. This is ear diseases that while very common problems, not a focus to Wall Street. The plan is to either divest or spinoff the legacy assets. Among these assets, I would like to highlight AM-125 which is a nasal spray for the treatment of vertigo. We have recently announced positive topline data from a Phase 2 trial," the executive explained to The Fly.
COVID-RELATED IMPACT: Discussing COVID-related impacts with The Fly, Altamira’s CEO noted that the "vertigo trial got delayed on several occasions because we treat patients after elective neurosurgeries and many hospitals didn't perform them due to COVID. Now I think things have normalized."
"With COVAMID, the opposite has been the case. We're trying to find the right wave of COVID when you can actually conduct a trial. This has been a bit of a challenge because we've tried several times but when we were ready to start, the number of cases had come down and we couldn’t conduct the trial as planned," the executive added.
RNA FOCUSED COMPANY: As the company prepares to divest or spinoff its legacy assets, Altamira's CEO acknowledged that "for investors right now it can appear a bit challenging in that we have so many different assets. We have this process of repositioning that we initiated last year with the announced divestiture or spinoff of the legacy business. I think we've been executing in on the things we planned to do. We're on track and we've had a lot of positive news flow. We still believe the plan makes sense and see a lot of potential in RNA. It’s going to be an exciting second half of this year."
"Meet the Company" is The Fly's recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.