Sol-Gel Announces Positive Top-Line Results from Epsolay® Phase 3 Program in Papulopustular Rosacea

  • All primary and secondary endpoints achieved in both Phase 3 clinical trials
  • Rapid efficacy demonstrated, with statistical significance reached as early as Week 2 compared with vehicle
  • Favorable safety and tolerability profile, similar to vehicle
  • Conference call and webcast today at 8:30 AM ET

NESS ZIONA, Israel, July 08, 2019 (GLOBE NEWSWIRE) — Sol–Gel Technologies, Ltd. (NASDAQ: SLGL) ("Sol–Gel" or the "Company"), today announced positive results from its Phase 3 program evaluating Epsolay microencapsulated benzoyl peroxide cream, 5%, made with the Company's proprietary microencapsulation technology, for the treatment of papulopustular rosacea. In two 12–week clinical studies, SGT 54–01 and SGT 54–02, Epsolay demonstrated statistically significant improvement in both co–primary endpoints of (1) the number of patients achieving "clear" or "almost clear" in the Investigator Global Assessment (IGA) and (2) absolute mean reduction from baseline in inflammatory lesion count. In an additional analysis, Epsolay demonstrated rapid efficacy achieving statistically significant improvements on both co–primary endpoints compared with vehicle as early as Week 2. Epsolay demonstrated a favorable safety and tolerability profile similar to vehicle.

James J. Leyden, M.D., dermatologist and Emeritus Professor CE of Dermatology at the University of Pennsylvania commented on the results, "It's exciting that Epsolay delivered outstanding and rapid efficacy with a microencapsulated benzoyl peroxide without irritating the sensitive skin of rosacea patients. These findings are extremely positive and, if Epsolay is approved, it has the potential to represent a significant advance in the treatment of papulopustular rosacea."

Epsolay is the first in a pipeline of dermatologic product candidates in development using Sol–Gel's proprietary microencapsulation technology. This platform was designed to enable drug substances to be entrapped in porous silica microcapsules in order to address the limitations of topical drug delivery by stabilizing active drug ingredients, extending drug delivery time and reducing potential irritation caused by direct application to the skin. In the fourth quarter of 2019, top–line Phase 3 results are expected for TWIN, the Company's investigational fixed–dose combination of microencapsulated benzoyl peroxide and microencapsulated tretinoin being studied for acne vulgaris.

"While we expected to see strong efficacy and tolerability with Epsolay, the rapid efficacy was a standout in our Phase 3 studies," said Dr. Alon Seri–Levy, Chief Executive Officer of Sol–Gel. "It's very difficult for patients of any dermatological disease, let alone rosacea, to wait months for a positive clinical result. That a quarter of Epsolay patients in both trials reached their treatment goals within a month, when the efficacy of existing topical products can be quite slow, is clinically meaningful and illustrates a clear unmet need within a rapidly growing marketplace."

SGT 54–01 and SGT 54–02 Trial Design

To assess the efficacy and safety of Epsolay in moderate–to–severe papulopustular rosacea, 733 patients aged 18 and older were enrolled in two identical, double–blind, vehicle–controlled Phase 3 clinical trials at 54 sites across the U.S. Patients were randomized at a 2:1 ratio to be treated once–daily with either Epsolay (n=493) or vehicle cream (n=240) for 12 weeks. After the initiation of treatment, clinical and safety evaluations were performed at Weeks 2, 4, 6, 8 and 12. The primary efficacy endpoints for both trials were success in IGA score at Week 12, defined as "clear" (0) or almost clear" (1) on a scale of 0 to 4, and a reduction in absolute mean inflammatory lesion count at week 12.

Baseline Papulopustular Rosacea Severity

In study SGT 54–01, patients in the Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 25.7 and 26.3, respectively. The proportion of patients with "moderate" (3) or "severe" (4) IGA in the Epsolay treatment group was 86.4% and 13.6%, respectively, and 88.1% and 11.9%, respectively, in the vehicle treatment group.

In study SGT 54–02, patients in Epsolay and vehicle treatment groups had a baseline mean inflammatory lesion count of 29.8 and 27.5, respectively. The proportion of patients with "moderate" (3) or "severe" (4) IGA in the Epsolay treatment group was 90.8% and 9.2%, respectively, and 91.8% and 8.2%, respectively, in the vehicle treatment group.

Primary Endpoint Results (intention–to–treat population)

SGT 54–01 SGT 54–02
Epsolay
N=243
Vehicle
N=118
p–value Epsolay
N=250
Vehicle
N=122
p–value
Proportion of patients achieving "clear" or "almost clear" at Week 12 43.5 % 16.1 % <0.001 50.1 % 25.9 <0.001
Absolute mean change in inflammatory lesion count from baseline at week 12 –17.4 –9.5 <0.001 –20.3 –13.3 <0.001

Secondary Endpoint Results (intention–to–treat population)

SGT 54–01 SGT 54–02
Epsolay Vehicle p–value Epsolay Vehicle p–value
Proportion of patients achieving "clear" or "almost clear" at Week 4 25.4 % 6.5 % <0.001 26.1 % 14.1 % 0.009
Absolute mean change in inflammatory lesion count from baseline at Week 4 –14.6 –8.7 <0.001 –16.7 –10.5 <0.001
Proportion of patients achieving "clear" or "almost clear" at Week 8 39.6 % 15.8 % <0.001 44.0 % 26.0 % 0.006
Absolute mean change in inflammatory lesion count from baseline at Week 8 –16.8 –10.6 <0.001 –20.0 –12.4 <0.001

Exploratory Endpoint Results (intention–to–treat population)

SGT 54–01 SGT 54–02
Epsolay Vehicle p–value Epsolay Vehicle p–value
Proportion of patients achieving "clear" or "almost clear" at Week 2 9.5 % 3.1 % 0.009 13.2 % 5.5 % 0.017
Absolute mean change in inflammatory lesion count from baseline at Week 2 –10.5 –5.5 <0.001 –13.0 –8.0 <0.001

Safety and Tolerability

Epsolay appeared to be generally safe and well–tolerated with a low rate of cutaneous side effects (e.g., dryness, scaling, itching and burning/stinging) comparable to vehicle. Adverse events were primarily mild to moderate in severity with the most frequently reported adverse events across both studies being application site erythema and application site pain reported by less than 3.4% of subjects. There was no treatment–related serious adverse events, with a combined total of 2 unrelated serious adverse events (1 Epsolay, 1 vehicle) reported across both trials. A combined total of 11 subjects (9 Epsolay, 2 vehicle) discontinued treatment due to an adverse event across both trials.

Preliminary Financial Results for the Second Quarter Ended June 30, 2019

The Company estimates its revenue for the second quarter of 2019 attributable to sales of its partnered generic product, acyclovir cream, 5%, with Perrigo to be approximately $7.0 million. To date, this is the only generic acyclovir cream available on the U.S. market. As of June 30, 2019, the Company's cash, cash equivalents, deposits and marketable securities is expected to be approximately $49.8 million, excluding the approximate $7.0 million in revenue from acyclovir cream, 5%, in the second quarter of 2019. Based on current assumptions, the Company expects its existing cash resources will enable funding of operational and capital expenditure requirements through the third quarter of 2020.

The estimates above represent the most current information available to the Company's management and do not present all necessary information for an understanding of the Company's financial condition as of and the results of operations for the quarter ended June 30, 2019. The Company is currently preparing its financial results for the three months ended June 30, 2019. The Company's actual results may differ materially from these estimates. The company plans to release final second quarter financial results on August 8, 2019.

Conference Call and Live Webcast (with slides) @ 8:30 AM Eastern Time
U.S. toll free: 877–282–0504
International: 270–215–9895
Passcode: 2570059
Webcast: https://edge.media–server.com/mmc/p/3ukswwiw

The webcast can be accessed live on the Events & Presentations section of the Company's website at http://ir.sol–gel.com. It will be archived for 30 days following the call.

About Epsolay

Benzoyl peroxide has not been approved by the FDA for the treatment of rosacea and may cause significant skin irritation in rosacea patients. Epsolay is an innovative topical cream containing microencapsulated benzoyl peroxide, 5%, in development for the treatment of papulopustular rosacea. Epsolay utilizes a patented technology process to encapsulate benzoyl peroxide within silica microcapsules to create a barrier between the medication and the skin. The slow migration of medication from the microcapsules delivers treatment doses onto the skin, while the barrier reduces the ability of benzoyl peroxide to induce the strong oxidation process that can result in significant skin irritation, such as erythema, burning and stinging. Silica is chemically inert, photochemically and physically stable, and is safely used in topical products. If approved, Epsolay has the potential to be the first FDA–approved single–active benzoyl peroxide prescription drug product.

About Papulopustular Rosacea

Papulopustular rosacea is a chronic and recurrent inflammatory skin disorder that affects nearly 5 million Americans.1 The condition is common, especially in fair–skinned people of Celtic and northern European heritage. Onset is usually after age 30 and typically begins as flushing and subtle redness on the cheeks, nose, chin or forehead. If left untreated, rosacea can slowly worsen over time. As the condition progresses the redness becomes more persistent, blood vessels become visible and pimples often appear. Other symptoms may include burning, stinging, dry skin, plaques and skin thickening.

About Sol–Gel Technologies

Sol–Gel is a clinical–stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol–Gel's current product candidate pipeline consists of late–stage branded product candidates that leverage our proprietary, silica–based microencapsulation technology platform, and several generic product candidates across multiple indications.

Forward–Looking Statements

This press release contains "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward–looking statements. These forward–looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward–looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. Forward–looking statements are based on information we have when those statements are made or our management's current expectation, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward–looking statements. Important factors that could cause such differences include, but are not limited to: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co–development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third–party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20–F filed with the Securities and Exchange Commission ("SEC") on March 21, 2019 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward–looking statements made in this press release. Any such forward–looking statements represent management's estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward–looking statements after the date of this press release to conform these statements to changes in our expectations.

For further information:
Sol–Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972–8–9313433

U.S. Investor Contact:
Chiara Russo
Solebury Trout
+1–617–221–9197
crusso@soleburytrout.com
Media Contact:
Stephanie Bukantz
Chamberlain Healthcare PR
+973–477–1814
Stephanie.bukantz@syneoshealth.com

Source: Sol–Gel Technologies Ltd.


1 Data on file, Sol–Gel

Solar Collectors and Solidarity Change Lives in Argentina

Volunteers install a solar water heater, made from recycled materials, with a 90-litre tank on the roof of a modest home in the Argentine municipality of Pilar, 50 km north of Buenos Aires. This unique thermal generation system was designed by Brazilian engineer José Alano, who did not patent it in order to facilitate its free use. Credit: Daniel Gutman/IPS

Volunteers install a solar water heater, made from recycled materials, with a 90-litre tank on the roof of a modest home in the Argentine municipality of Pilar, 50 km north of Buenos Aires. This unique thermal generation system was designed by Brazilian engineer José Alano, who did not patent it in order to facilitate its free use. Credit: Daniel Gutman/IPS

By Daniel Gutman
PILAR, Argentina, Jul 8 2019 – “This is the best thing ever invented for the poor,” says Emanuel del Monte, pointing to a tank covered in black tarps protruding from the roof of his house. It forms part of a system built mostly from waste materials, which heats water through solar energy and is improving lives in Argentina.

Thanks to him, hundreds of families in three poor neighbourhoods on the outskirts of the Argentine capital now have hot water for bathing. They used to heat water in pots but had abandoned the practice in recent years because of the high costs of cooking gas.

Del Monte, 32, his wife and five children live in an unpainted cinder-block house with a half-built brick perimeter wall in the neighborhood of Pinazo, Pilar municipality, about 50 km north of Buenos Aires.”When they first tell you about it, you don’t understand what they’re talking about. Then you realize it’s an opportunity you can’t miss out on because it changes your life.” – Verónica González

Pinazo is a community of about 5,000 people that reflects the social deterioration in the 24 municipalities surrounding Buenos Aires, which together with the capital account for more than 13 million of the country’s 44 million inhabitants.

Neighbourhoods on the outskirts of the capital are home to 130,000 of the 200,000 people who lost their jobs in 2018 in this South American country, where the economy is in a deep crisis and poverty has climbed to 36 percent of the population, according to official figures.

The paved streets of Pinazo are lined with houses with roof tiles and gardens, run-down but clearly middle-class.

But if you turn down the dirt side streets, many of the homes are shacks made of boards, corrugated metal and even pieces of tarp, between empty dirt lots where cats, dogs and chickens wander about.

On some Saturdays, however, things get busy on several of the empty lots: dozens of volunteers, mostly young people, work for hours building solar heaters, together with many local residents.

The volunteers gather early on one side of the freeway from Buenos Aires and come to the neighbourhood together, in cars and trucks loaded with huge bags full of plastic bottles, cans, cardboard boxes, old mattresses and tarps.

Mariana Alio and her husband, Emanuel del Monte, stand in front of their house in Pinazo, a poor neighbourhood in the municipality of Pilar, in Greater Buenos Aires. On the roof they have a solar water heater, covered with mattresses and tarps that keep it warm, which provides them with hot water for bathing – a luxury their family had to do without because of the high cost of the cooking gas they used to heat water in pots. Credit: Daniel Gutman/IPS

Mariana Alio and her husband, Emanuel del Monte, stand in front of their house in Pinazo, a poor neighbourhood in the municipality of Pilar, in Greater Buenos Aires. On the roof they have a solar water heater, covered with mattresses and tarps that keep it warm, which provides them with hot water for bathing – a luxury their family had to do without because of the high cost of the cooking gas they used to heat water in pots. Credit: Daniel Gutman/IPS

In addition, local residents at the site gather useful waste products, which they used to burn or throw into the polluted stream that gives its name to the neighborhood, since there is no garbage collection system.

Convened by the non-governmental organisation Sumando Energías, the volunteers say their goodbyes just before sunset, after building and installing on the roofs of up to four houses solar energy collectors and 90-litre thermal tanks, which keep the water warm because they are covered with mattresses and tarps.

“Each collector is made with 264 plastic bottles, 180 cans and 110 cardboard boxes. Most of the materials we use are reused,” Pablo Castaño, 32, who founded Sumando Energías in 2014, tells IPS as he walks around, supervising the work of the volunteers.

“I am convinced that sustainability is the only way to improve things for the poor. Social and economic solutions go hand in hand with environmental solutions,” says Castaño.

The head of Sumando Energías says he came into contact with the conditions in low-income areas while volunteering for another NGO, Techo (Roofs), dedicated to providing decent housing in slums, and became interested in renewable energy while studying to become an industrial engineer.

Castaño was born and raised in the southern province of Río Negro, near Vaca Muerta, the giant unconventional oil and gas field that the government is counting on to give a boost to Argentina’s declining economy. But he argues that “it is not the burning of fossil fuels that is going to save us.”

The solar collectors consist of 12 parallel two-metre-long PVC tubes covered with cans that absorb heat from the sun and heat the water inside the pipe. They are then wrapped in plastic bottles and cardboard.

Young volunteers from Sumando Energías build solar collectors in the Pinazo neighborhood. The NGO trains them in the development of clean energies that provide social, environmental and economic solutions in poor neighbourhoods in Argentina. Credit: Daniel Gutman/IPS

Young volunteers from Sumando Energías build solar collectors in the Pinazo neighborhood. The NGO trains them in the development of clean energies that provide social, environmental and economic solutions in poor neighbourhoods in Argentina. Credit: Daniel Gutman/IPS

“That’s how we generate the greenhouse effect that keeps the temperature up. The next step is to set up a closed circuit between the pipes and the tank, which is placed on top, as hot water becomes dense and tends to rise. After about 60 round-trip cycles, the water is hot, between 40 and 65 degrees (Celsius),” says Lucía López Alonso, one of the volunteers.

“What is generated is not electricity, but solar thermal energy,” she tells IPS.

Emanuel del Monte’s wife, Mariana Alio, who works at a greengrocer’s, says their family used to heat up water in pots using cooking gas, for bathing, but economic difficulties forced them to only use gas for cooking.

“Some people in the neighbourhood still think I’m crazy when I tell them that I now have hot water from a system built using waste products,” says Del Monte, who recently lost his job as a maintenance worker in Escobar, a municipality near Pilar, and today does odd jobs, mowing lawns or as a handyman.

In both Pilar and Escobar, slums exist side by side with summer homes and gated communities – some of them wealthy and all of them surrounded by walls and fences and protected by private security guards – where slum-dwellers can find casual work.

“(José) Alano didn’t patent it in order for his design to be used freely. We also follow his philosophy and uploaded the solar collector manual to our Facebook page, so anyone can access it,” Castaño explains.

In four years, Sumando Energías has built and installed 174 solar collectors in neighbourhoods on the outskirts of Buenos Aires.

In the poor neighbourhood of Pinazo, on the outskirts of the Argentine capital, young volunteers cover a 90-litre thermal tank with a layer of foam recycled from old mattresses, which helps keep water heated by a solar collector - also made with old plastic bottles and cans - warm. Credit: Daniel Gutman/IPS

In the poor neighbourhood of Pinazo, on the outskirts of the Argentine capital, young volunteers cover a 90-litre thermal tank with a layer of foam recycled from old mattresses, which helps keep water heated by a solar collector – also made with old plastic bottles and cans – warm. Credit: Daniel Gutman/IPS

Castaño explains that the system for making solar collectors with reused materials was designed in 2002 in Brazil by retired mechanic José Alano, who promoted it in the south of his country.

The activist says the units have a useful life of 10 years or more, but points out that they last longer because they do not have mechanical parts. In addition, the plastic bottles can be easily replaced when they eventually darken and no longer perform their function of maintaining heat.

The aim of the initiative is not only to provide a solution for poor families but also to pass on know-how about renewable energy to the volunteers, who donate 1,500 pesos (about 33 dollars), which are used to cover the cost of the materials.

“We also receive some donations from companies, but we don’t accept any from companies linked to the fossil fuel business,” says Castaño.

Sumando Energías is now working on prototypes of solar cookers that will allow families like those living in the Pinazo neighbourhood, most of whom depend on the informal labour market, to cut their dependence on cooking gas cylinders, which cost 10 dollars to refill.

“Many of us here have had 25-litre electric water heaters, but they tend to burn out because the electric power source is unreliable,” says Verónica González, a 34-year-old local resident who lives with her mother, three daughters and a niece, as she cuts plastic bottles alongside the volunteers.

Her family is among the latest to benefit from the solar heaters designed by Alano. “When they first tell you about it, you don’t understand what they’re talking about. Then you realize it’s an opportunity you can’t miss out on because it changes your life,” she tells IPS.