ThykamineTM is an active lead drug candidate with excellent safety and efficacy profiles confirmed in several pre-clinical and cinical studies targeting inflammation.
In Phase 2a, the Corporation conducted a clinical trial: a 2-week, exploratory randomized, double-blind, parallel-group, dose-ranging, placebo-controlled safety, tolerability, biomarker and efficacy clinical study of ThykamineTM rectal enema in patients with active mild-to-moderate distal ulcerative colitis.
The primary objective of the study was met. Administration of 250 mg, 500 mg and 1000 mg doses of ThykamineTM rectal enema once daily was safe and well tolerated in subjects with active mild-to-moderate distal ulcerative colitis. There was a statistically significant (p<0.05) reduction in the mean change from baseline in the rectal bleeding sub-score of the modified Mayo score, a cardinal symptom/sign of ulcerative colitis, for the ThykamineTM – 250 mg dose compared to placebo at Endpoint/Day 14.
Among the biomarkers, there was a statistically significant reductions in the fecal lactoferrin (FL) levels, a biomarker with high specificity and sensitivity to detect intestinal inflammation, in serum Transforming Growth Factor-beta (TGF-b) and serum M-30 apoptosome.
The objective evidence of activity as per the biomarkers’ reductions and the clinical assessment’s results of the clinical study together have demonstrated the biological activity of Thykamine™ rectal enema in patients with active mild-to-moderate distal ulcerative colitis within a very short treatment duration.
Indications currently being pursued with ThykamineTM
Atopic Dermatitis (Eczema) is a chronic, relapsing inflammatory skin disease characterized by itchy skin lesions and rashes. Although this condition affects people of all ages, it is most common among infants and children. In general, the prevalence of atopic dermatitis is increasing worldwide and is higher in developed nations than in other parts of the world.
Prevalence: Atopic Dermatitis affects 15 to 30% of children and 2 to 10% of adults worldwide. It is associated with co-occuring disorders such as asthma, rhinitis, food allergies and bacterial infections. Quality of Life of the patient and family can be impaired. It is estimated that Atopic Dermatitis affects 9 to 30 percent of people in United States.
Development Stage: Devonian has initiated a Phase 2 clinical study in Q2-2017 which should be completed in Q2‑2018. This will be a double-blind, placebo-controlled study of topical ThykamineTM in patients with mild-to-moderate atopic dermatitis.
Ulcerative colitis (UC) is a chronic relapsing form of inflammatory bowel disease that causes inflammation and ulcers in the colon. Symptoms can range from mild to severe with disease onset usually occurring in young adults. Intermittent rectal bleeding, crampy abdominal pain and diarrhea often are symptoms of ulcerative colitis. Its course is unpredictable but with a strong likelihood of life-long disease. It can be debilitating and sometimes can lead to life-threatening complications.
Prevalence: The disease is more common in northern regions of the world. Approximately 238 of 100,000 adults are affected by ulcerative colitis. It is estimated that up to 2 million people are affected in United States.
Development Stage: Devonian has plans for a larger Phase 2b clinical trial and of longer treatment duration: a 12‑week, randomized, double‑blind, parallel-group, dose-ranging, placebo-controlled efficacy, safety and tolerability study of ThykamineTM rectal enema to treat patients with active mild-to-moderate distal ulcerative colitis. Devonian intends to request a meeting with the FDA by the end of 2017. The meeting will allow Devonian to submit to the FDA the results of the in vitro and in vivo pharmacology studies, the safety pharmacology and toxicology studies, and the results of the Phase 1 and 2a clinical studies along with the clinical trial protocol of the planned Phase 2b study. Management believes that the safety and efficacy profile of ThykamineTM demonstrated in all the former studies should provide justification for the FDA to allow Devonian to proceed with the Phase 2b clinical trial without any safety issues.
Cosmeceuticals have become the fastest-growing segment of the cosmetics and personal care industry.
There are three different categories of skin care products:
– “pharma-quality” dermatologist/physician formula brands;
– prestige products; and
– mass-market products.
A trend is that the cosmeceutical products with the best potential will be those that are backed by science.
All of Devonian’s skin-care products are developed by the same approach as its pharmaceutical products, with strong safety and efficacy data, which positions these products as science-based.
The first derma-cosmeceutical products that Devonian has developed are women’s anti-aging product line consisting of day, night, and eye creams. R-Spinasome™, Devonian’s proprietary natural active ingredient is included is these market-ready, patent-pending, products.
Devonian intends to market it under PurGenesis™ brand or as a private label with marketing partners.
For more information on Derma-cosmeceutical products, please click here