OUR SCIENCE TELLS A STORY

PRODUCTS WITH THE POTENTIAL TO CREATE CHANGE

Our diverse and expanding therapeutic portfolio includes drug candidates in various stages of clinical development.

PRODUCT PIPELINE

Our current development portfolio contains 4 clinical candidates for which we own the worldwide rights.
Product
Clascoterone cream 1%

Androgen receptor inhibitor

Indication
Acne
Product
Clascoterone solution 7.5%

Androgen receptor inhibitor

Indication
Androgenetic alopecia
Product
CB-06-01

Antibiotic

Indication
Acne
Product
CB-06-02

Immune modulator

Indication
Genital warts

PRODUCTS IN DEVELOPMENT

  • Clascoterone cream 1%

    Clascoterone cream 1% for treatment of acne

    Treatment target

    Clascoterone cream 1% is under investigation as a first-in-class topical androgen receptor inhibitor for the treatment of acne.

    Science story

    Clascoterone is a novel small molecule androgen receptor inhibitor that when applied to the skin (topically) reaches the sebaceous glands.1 Clascoterone cream 1% has the potential to be the first topical anti-androgen without notable local or systemic side effects. Unlike oral anti-androgen therapies for acne, clascoterone may be used in both males and females.2 Clascoterone cream 1% has a novel mechanism of action, targeting androgen receptors at the site of application, inhibiting local dihydrotestosterone (DHT), a key driver of acne lesion development.1 Laboratory studies show that clascoterone inhibits lipid production from oil-producing cells (sebocytes) and also reduces proinflammatory cytokines, which are mediators that are influenced by androgens. As a result of decreased cytokine and lipid production, pathways that foster acne lesion development are disrupted by clascoterone.2

    Development stage

    FDA set PDUFA as August 27, 2020.

  • Clascoterone solution 7.5%

    CLASCOTERONE SOLUTION 7.5% FOR TREATMENT OF AGA

    Treatment target

    Clascoterone solution 7.5% is a novel AR inhibitor that targets androgen receptors in the scalp and is currently being studied for the treatment of androgenetic alopecia (AGA).

    Science story

    AGA is the most common cause of hair loss.3 AGA is driven by dihydrotestosterone (DHT). Androgens normally stimulate terminal hair production in many sites of the body, like the beard and the axillary regions, but exert an opposite effect to suppress hair growth on the genetically predisposed frontal and vertex scalp. Therefore, people with scalp hair follicles that are genetically sensitive to DHT experience progressive hair follicle miniaturization, or hair thinning, and shortening of the hair growth cycle, resulting in characteristic “male pattern baldness” or thinning hair in genetically predisposed females.
    Clascoterone solution 7.5% acts by inhibiting DHT’s binding with androgen receptors in scalp hair follicles and thus may interfere with DHT’s effect on scalp hair loss.4 Laboratory studies show that clascoterone solution 7.5% reduces production of inflammatory mediators involved with hair miniaturization.5

    Development stage

    A Phase II dose ranging study with clascoterone solution ended in early 2019. Clascoterone solution 7.5% was selected as the best candidate for a Phase III adult male AGA study set to begin in 2020. A Phase II study involving female AGA subjects is also scheduled to begin Q4 2019.

  • CB-06-01

    CB-06-01

    Treatment target

    CB-06-01 is a novel topical antibiotic currently under development and investigation for acne. It is a topical antibiotic that could provide another option against Cutibacterium acnes bacteria.

    Science story

    Many C acnes strains are resistant to commonly prescribed antibiotics for acne. There is a need for a novel antibiotic treatment to help patients who suffer from acne.

    Development stage

    CB-06-01 has successfully completed a POC study and is now in formulation optimization.

  • CB-06-02

    CB-06-02

    Treatment target

    CB-06-02, also referred to as AS 101, is a topical treatment for genital warts. It acts to support patients’ natural immune responses against human papillomavirus (HPV) and its warts.

    Science story

    Current topical treatments can be ineffective and frequent recurrence of genital warts can affect the sexual health of millions of patients.

    Development stage

    CB-06-02 has completed a Phase II proof-of-concept clinical trial.

References: 1. Mazzetti A, Moro L, Gerloni M, Cartwright M. Pharmacokinetic profile, safety, and tolerability of clascoterone (cortexolone 17-alpha propionate, CB-03-01) topical cream, 1% in subjects with acne vulgaris: An open-label phase 2a study. J Drugs Dermatol. 2019;18(6):563. 2. Rosette C, Agan FJ, Mazzetti A, Moro L, Gerloni M. Cortexolone 17α-propionate (clascoterone) is a novel androgen receptor antagonist that inhibits production of lipids and inflammatory cytokines from sebocytes in vitro. J Drugs Dermatol. 2019;18(5):412-418. 3. Qi J, Garza LA. An overview of alopecias. Cold Spring Harb Perspect Med. 2014;4(3):1. 4. Blume-Peytavi U, Mazzetti A, Moro L, Fragasso E, Cartwright M. A phase II, randomized, double-blind, vehicle controlled, dose escalating study evaluating clascoterone (cortexolone 17α-propionate, CB-03-01) topical 2.5%, 5.0%, 7.5% and vehicle bid & 7.5% qd in adult males with androgenetic alopecia. Poster presented at: 14th Annual Maui Derm; January 28-February 1, 2018; Kihei, HI. 5. Rosette C, Rosette N, Mazzetti A, Moro L, Gerloni M. Cortexolone 17α-propionate (clascoterone) is an androgen receptor antagonist in dermal papilla cells in vitro. J Drugs Dermatol. 2019;18(2):197-201.

LATEST NEWS

November 13, 2019
chevron right icon

Cassiopea Announces First Patient to be Enrolled in Phase II Trial for the Treatment of Androgenetic Alopecia in Females with Clascoterone Solution

November 8, 2019
chevron right icon

Cassiopea Announces FDA Acceptance of its New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years

August 20, 2019
chevron right icon

Cassiopea Announces FDA Submission of New Drug Application for Clascoterone Cream 1%, the First New Mechanism of Action for Acne in Nearly 40 Years

Breezula is under investigation in the United States for the treatment of androgenetic alopecia, and the safety and efficacy have not been established by the United States Food and Drug Administration (FDA). The proposed brand name for clascoterone solution 7.5% is not FDA-approved.

Winlevi is under investigation in the United States for the treatment of acne, and the safety and efficacy have not been established by the United States Food and Drug Administration (FDA). The proposed brand name for clascoterone cream 1% is not FDA-approved.