Item 8.01 Other Events.
On November 19, 2021, the Company announced efficacy and safety data from its Phase 1b proof of concept study evaluating a single treatment of one of the Company’s lead product candidates, DMT410, to treat multiple aesthetic skin conditions.
The open-label, single-center study of 10 female patients receiving one treatment of DMT410, which consists of one topical application of Spongilla powder followed by one topical application of 64 units of OnabotulinumtoxinA (BOTOX®) to the upper face. Patients were observed at four weeks, eight weeks, 12 weeks, and 16 weeks to collect safety and efficacy data and track duration of effect.
The endpoints of the study included reduction in pore size, improvements in the Global Aesthetic Improvement scale, improvement in luminosity and brightness, reduction in sebum production, reduction in fine lines, and reduction of glabellar, forehead, and lateral canthal lines.
|
·
|
Global Aesthetic Improvement (GAI) - the physician measured an improvement in patient’s overall GAI at week 4 in 70% of patients, 80% of patients at week 8, and 60% of patients at week 12. GAI is measured on a 4-point scale, with at least a 1-point reduction being a 25% improvement. The mean improvement in GAI score from baseline was 0.8 at week 8.
|
|
|
|
|
·
|
Pore size - the physician observed an improvement in pore size in 50% of patients at week 4, 60% of patients at week 8, and 50% of patients at week 12. An improvement in pore size is measured on a 4-point scale, with at least a 1-point reduction being a 25% decrease in pore size. The mean improvement in pore size from baseline was about 0.7 at week 8.
|
|
|
|
|
·
|
Luminosity - the intensity of light area reflected on the skin, improved in 50% of patients at week 4, 90% of patients at week 8, and 90% of patients at week 12. The mean improvement of luminosity from baseline, on a scale of 0 to 10 points, peaked at 1.4 points of improvement at week 12.
|
|
|
|
|
·
|
Brightness - a measurement of the combined uniformity of skin coloring and texture, improved in 30% of patients at week 4, 60% of patients at week 8, and 60% of patients at week 12. The mean improvement of brightness from baseline, on a scale of 0 to 10 points, peaked at 0.7 points of improvement at week 12.
|
|
|
|
|
·
|
Upper facial lines - a measurement of the visible improvement of a patient’s forehead, lateral canthal, and glabellar lines did not show clinically meaningful improvement. This result is consistent with the knowledge that botulinum toxin is only approved for injections into the muscle to treat these endpoints.
|
In terms of safety and tolerability, DMT410 was generally safe and well tolerated with no adverse events reported, no withdrawals due to treatment-related adverse events, and no potential distant spread of toxin reported.
Forward- Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or the Company’s financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.