Novaliq GmbH | August 10, 2022
Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, announced the submission of a New Drug Application to the U.S. Food and Drug Administration seeking approval for CyclASol® a proposed novel treatment for the signs and symptoms of dry eye disease.
CyclASol® has demonstrated in two pivotal studies fast onset of therapeutic effect in the indication, clinical meaningful improvement of ocular surface damage, and excellent tolerability. Results from a 12-month long-term study confirmed that the effects are maintained, and even improved for most sign and symptom endpoints.
"This is the first submission of a novel product category of water-free topical drug therapies utilizing EyeSol® as a drug carrier. CyclASol® is a first-of-a-kind drug therapy and aims to expand treatment success for patients with dry eye disease and their eye care professionals. If approved by the FDA, CyclASol® addresses important unmet medical needs in DED through its ocular surface healing effect combined with high comfort of administration."
Christian Roesky, Ph.D., CEO, Novaliq
Dry eye is one of the most common ocular surface disorders, with approximately 18 million Americans diagnosed with DED.1,2 Inflammation and immunologic processes play a key role in the pathology of the disease.
A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact expected visual outcomes after these surgeries.3,4 The impact of the corneal surface damage secondary to DED on visual function is an underestimated aspect of the disease. Multiple guidelines recommend treatment of the corneal surface damage prior to ocular procedures. A high unmet need remains for better tolerated drugs with an early onset of therapeutic effect, which are compelling to be used and prescribed.5,6
"We are very proud to see another product rapidly moving to the market, which marks yet another important inflection point and milestone in Novaliq's growth trajectory", said Dr. Mathias Hothum, board member and managing director of dievini. "We are currently evaluating the commercialization strategies which includes talking to interested parties."
CyclASol® is a first-of-a-kind topical treatment of cyclosporine, a potent anti-inflammatory and selective immunomodulatory drug. Whilst not water-soluble, cyclosporine is soluble in the EyeSol® excipient perfluorobutylpentane allowing for its improved bioavailability and better efficacy on the target tissue. The product contains no oils, no surfactants and is preservative-free due to the novel carrier. This provides additional clinical benefits for patients, such as improved tolerability and decreased visual disturbances.
The NDA is supported by safety and efficacy results in over 1,000 patients with DED from a Phase 2 dose finding study, the Phase 2b/3 ESSENCE-1 study, the Phase 3 ESSENCE-2 study and its open label extension study.7,8
CyclASol® has demonstrated in two independent adequate and well-controlled, multicenter studies clinically meaningful and statistically significant improvements in the indication.
Effects on the ocular surface include a statistically significant reduction in total corneal fluorescein staining score favoring CyclASol® in both studies at Days 15 and 29. Up to 71.6% of patients responded within four weeks with a clinically meaningful improvement of ≥ 3 grades in total corneal staining. This proportion of responders was significantly higher compared to vehicle-treated patients in both studies. Responders showed also statistically significant improvements in a variety of symptoms compared to non-responders at day 29. The ASCRS guidelines recognize corneal staining as the single most important clinical sign of DED as it indicates the level of epithelial damage and visual impairment, and if left undertreated, DED can become chronic and more difficult to treat.3
Effect on tear production: In both studies, compared to vehicle at the end of treatment, there was a statistically significant (p<0.05) higher percentage of patients with increases of ≥ 10 mm from baseline in Schirmer's tear test score at Day 85 and Day 29, respectively, confirming a known effect of the active ingredient cyclosporine. Meeting this endpoint in two independent studies is clinically meaningful on its own and considered to demonstrate efficacy for the treatment of signs and symptoms of DED.
Head-to-head data versus Restasis™ from the phase 2 study suggest that CyclASol® has a stronger and faster therapeutic effect on the ocular surface.8
Maintenance of effect results from the long-term study CYS-005 confirmed that the effect of CyclASol® was maintained, and even improved for most endpoints, over the 52-week treatment period.
Safety and Tolerability: Tolerability of CyclASol® was shown by high drop comfort patient ratings in both studies. The most common adverse reaction observed was instillation site reactions, which was reported in 8.1% of patients in the pooled studies. These were in all but one case mild. The only other adverse reaction reported in > 2% of the patients was visual acuity reduced (2.7%).
Novaliq is a biopharmaceutical company focusing on the development and commercialization of first- and best-in-class ocular therapeutics based on EyeSol®, the worldwide first water-free technology.
EyeSol® is Novaliq's proprietary water-free technology using ultrapure semifluorinated alkanes (SFAs) that are physically, chemically, and physiologically inert with excellent biocompatibility and a very good safety profile. Novaliq offers an industry-leading portfolio addressing today's unmet medical needs of millions of patients with eye diseases.
Zivo | June 28, 2022
ZIVO Bioscience, Inc. is a U.S.-based R&D company dedicated to the study, development and commercialization of natural nutritional compounds and bioactive molecules derived from proprietary algal strains, announced joining the Russell Microcap® Index (^RUMIC) as a result of the Russell indexes annual reconstitution in 2022.
Russell Microcap® Index membership that remains in place for a course of 12 months, means automatic inclusion in the appropriate value style and growth indexes. Membership for FTSE Russell's Russell indices is generally determined by market-capitalization rankings and style characteristics.
A leader in global indices, FTSE Russell, offers cutting-edge analytics, benchmarking, and data solutions to investors all over the world. FTSE Russell creates thousands of indexes to measure and benchmark markets and asset classes for over 70 nations, covering 98 percent of the world's investable markets. It emphasizes on applying the strict industry norms in governance and index design and also embraces the IOSCO Principles.
We are pleased to be added to the Russell Microcap® Index this year. Our inclusion reflects continued interest in our stock along with long- and near-term growth expectations as we evolve and execute on our business strategy, I also look forward to expanding our stock’s exposure to a broader investor audience, including more institutional investors, as a result of ZIVO’s inclusion.”
John Payne, President and Chief Executive Officer of ZIVO Bioscience.
Russell indexes are increasingly used by institutional investors and investment managers for index funds for benchmarking active investment strategies. Approximately US$12 trillion in assets are benchmarked against Russell’s US indexes.
Phenomix Sciences | May 27, 2022
Phenomix Sciences (Phenomix), a precision biotechnology company bringing data intelligence to the treatment of obesity, announces today the launch of its biobanking registry and outcome study. The registry will study variability in obesity by looking at patients' DNA, metabolomics, hormones, patient behavior, assessments, and treatment outcomes. The data collected will supplement the 20 billion unique data points that make up the Phenomix Sciences Obesity Platform. Mayo Clinic is the first to enroll in the registry with its Rochester site set to contribute patient outcomes from 2,000 patients undergoing treatment for obesity to its biobank.
The biobanking registry is a critical milestone in Phenomix's mission to conquer obesity by creating unprecedented access to its clinical and molecular information throughout all stages and phenotypes of the disease. Outcomes data generated from the biobanks across the registry will supplement Phenomix's database of biological and clinical data matched to the four obesity phenotypes. Insights generated from the database are being used to develop more predictive tests to identify the right intervention for each patient with obesity. This will allow for a better understanding of variability in patient outcomes when undergoing obesity treatments. Despite the justifiable excitement about new weight management products such as semaglutide and tirzepatide, several clinical studies from Phenomix's founders indicate that patient response varies with underlying phenotype. Thus, for many patients, it will open the door to the most effective and appropriate intervention for their unique phenotype.
A growing body of evidence indicates that obesity is not a single disease with a single treatment type, but a constellation of diseases. Obesity's roots lie in individual DNA; however, evidence suggests there is a complicated web connecting obesity to age, race, and gender, education, and socioeconomic status. Understanding a person's obesity phenotype — the combination of genes with environmental and behavioral factors — can help pinpoint the cause of weight gain. Phenomix's phenotypes are based on research from its physician founders, Andres Acosta, MD, PhD and Michael Camilleri, MD of Mayo Clinic, that has demonstrated when patients have been phenotyped and prescribed the right medications, they can achieve up to 16 percent total body weight loss (TBWL).
In addition to creating the first biobanking registry of this type, this is the first large scale study to monitor phenotypes in patients with obesity being treated with a variety of treatments. The impact of this biobanking registry and the data it will yield has the potential to change the entire system's approach to obesity, from a treatment recommendation to the way payers determine coverage and how industry combines diagnostics testing with drug therapy.
This unique biobanking registry will provide critical and contemporary data on obesity outcomes, impacting every stakeholder in the episode of care, This registry is an important opportunity to make vast strides in how we understand the complexities of obesity treatment. All obesity programs should be seeking the opportunity to participate and contribute to this registry. The more data we have on the variables that contribute to an individual's obesity diagnosis, the more lives we can save by putting the best treatment plan forward. We believe the investment in the biobanking registry will better support obesity centers by providing concrete evidence and insight into how DNA and other factors need to be considered in treatment. Patients can benefit greatly from achieving the desired outcome the first time around, and payers avoid paying for trial-and-error approaches and can reduce overall co-morbid conditions for members."
Mark Bagnall, CEO of Phenomix Sciences.
About Phenomix Sciences
Phenomix Sciences is a biotechnology pioneer on a mission to conquer obesity globally through the science of phenotyping, the understanding of how genes combined with environmental and behavioral factors can inform obesity treatment plans. Mayo Clinic physicians, scientists, and researchers, Andres Acosta, MD, and Michael Camilleri, MD, founded the company under the belief that the key to understanding obesity is unprecedented access to its clinical and molecular information throughout all stages and phenotypes of the disease. Phenomix leverages data intelligence for yielding better accuracy in predicting individual patient response to specific weight loss interventions and reducing the variability in weight loss results for patients.