Product Pipeline

Product Pipeline

Product Pipeline

Therapeutics for Serious Skin Diseases

We are developing next generation therapeutics to treat serious skin diseases.

Our product pipeline currently includes 4 programs focused on the treatment of serious acne, plaque psoriasis and atopic dermatitis.

Three of Botanix product candidates utilize a synthetic form of a chemical also found in natural extracts known as 2-[(1R,6R)-6-isopropenyl-3-methylcyclohex-2-en-1-yl]-5-pentylbenzene-1,3-diol. Unapproved natural extract forms of this molecule (known as cannabidiol) have been proposed as treatments for a range of diseases and Cannabidiol has been successfully studied in numerous late stage clinical trials to treat epilepsy, pain and arthritis (amongst other indications). No well-controlled human clinical studies have ever been conducted with Cannabidiol to treat skin disease, despite significant scientific support for the drug’s mechanism of action in a range of serious skin diseases.

Click on a program to view details.

BTX1503 - Moderate to Severe Acne

BTX1503 is a transdermal gel formulation for the treatment of serious acne in adults and teenagers.

Acne is a skin condition that manifests in pimples, lumps and cysts and is the leading cause of visits to dermatologists and is a leading cause of psychological difficulties in adolescents. It is the most common skin disorder in the US affecting 40-50 million Americans and in 2013 was reported to cost more than $2.3 Billion in prescriptions.

Acne has multiple pathogenetic pathways including sebum overproduction, unwanted sebocyte proliferation, inflammation and bacterial infection. The active being studied by Botanix has been shown in scientific studies to:

  • normalize excessive lipid synthesis of human sebocytes
  • suppress cell proliferation
  • provide an anti inflammatory effect
  • potentially reduce bacterial infection

Potential benefits of BTX1503:

  • BTX1503 could reduce the occurrence or severity of serious acne
  • BTX1503 could be a significant alternative to some existing therapies (such as isotretenoin) that are associated with serious side effects, including suicide

BTX1308 - Plaque Psoriasis

BTX1308 is a transdermal gel formulation for the treatment of plaque psoriasis.

Psoriasis is a serious medical condition affecting the autoimmune system with about 80% of patients having plaque psoriasis, characterized by raised reddish skin covered with white scales. About 7.5 million Americans have psoriasis and a significant proportion of severe patients cannot be treated with the current standard of care, which is high doses of steroids or monoclonal antibodies.

Psoriasis is an inflammatory disease characterised in part, by epidermal keratinocyte hyper-proliferation. The active being studied by Botanix has been shown to inhibit keratinoctye proliferation in a concentration dependent manner and has anti-inflammatory and anti-bacterial properties

Potential Benefits of BTX1308:

  • BTX1308 could reduce the occurrence and severity of psoriasis lesions
  • BTX1308 could reduce keratinocyte proliferation, inflammation which along with its anti-bacterial properties may have a synergistic total effect on the disease

BTX1204 - Atopic Dermatitis

BTX1204 is a transdermal gel formation for the treatment of atopic dermititis.

Atopic dermatitis (or severe eczema) is a common inflammatory skin disease most commonly seen in children. An estimated 31.6 million people in the United States have symptoms of eczema or eczematous conditions and at least 17.8 million people have symptoms of atopic dermatitis, considered a more severe form of eczema. Atopic dermatitis is characterized by a loss of barrier function, which is the impermeable outer layer of the skin, and skin inflammation.

The endocannabioid system of the skin has a crucial role skin derived sensory phenomena such as pain and itch. The active being studied by Botanix can exert potent analgesic effects by activation of CB1 and/or CB2 receptors in the skin and possibly other receptors at sensory nerve terminals and/or inflammatory cells

Potential Benefit of BTX 1308:

  • PBX 1308 could have a role reducing skin inflammation and improving skin tone

BTX 1701 - Mild Acne
BTX 1701 is a novel product for mild acne based on the Company’s Permetrex™ skin delivery technology.

The facial cleanser market is a US$1.5 billion annual market, dominated by well-known brands including Cetaphil®, Biore® and Johnson & Johnson’s Clean and Clear®. Many of these cleanser products however, contain significant amounts of alcohol, which can dry out the skin, as well as preservatives that can cause allergic reactions for some users.

The BTX 1701 formulation avoids these challenges and aims to provide superior cleansing effect, by utilizing the Permetrex™ skin delivery technology in conjunction with a novel oil clearing agent.

BTX 1701 has been studied in a small clinical study and preliminary results show that BTX 1701 applied daily reduces oil levels on the skin and removes P. acnes, the bacteria responsible for the development of acne, from the surface of the skin more effectively than a leading facial cleanser product.

BTX 1701 presents a significant opportunity to complement the Company’s lead acne product, by providing a product solution for patients with earlier stage oily skin and mild acne.

How Cannabidiol Works
Botanix is focused on modulating the body’s ‘endocannabinoid system’ of receptors which regulates skin function, growth and renewal.  While the skin acts as a physical and chemical barrier to constant environmental challenges, its layers contain active organs, neuronal networks and systems that keep the skin in balance or ‘homeostasis’.

Only in the last two decades, has a natural cannabinoid receptor system been discovered in the human body. Identification of the main cannabinoid receptors (CB1 and CB2 ), their endogenous lipid ligands (endocannabinoids), biosynthetic pathways and metabolizing enzymes (collectively termed the endocannabinoid system), coupled with the discovery and/or rational design of numerous ligands for CB receptors, has triggered an exponential growth in studies exploring the continuously growing regulatory functions of this newly discovered physiological system both in health and disease.

Recent scientific research by Botanix and others has confirmed that cannabidiol plays a significant role in normalizing unwanted skin growth, reducing excessive production of oils and reducing inflammation and infection.

The endocannabinoid system has been implicated in the regulation of skin cell proliferation, survival and differentiation, the delicate balance of which is a key determinant of proper skin balance or homeostasis.