Botanix Pharmaceuticals tracks commercial dermatology path
Botanix Pharmaceuticals plans to lodge a new drug application for Sofpironium Bromide gel in the second half of 2022.
Botanix Pharmaceuticals (ASX: BOT) has provided the market with an update on its progress in transforming into a commercial-stage dermatology company following the acquisition of its latest asset, Sofpironium Bromide.
The dermatology company had been focused on developing synthetic cannabinoid treatments for skin diseases including rosacea and acne before it announced the acquisition earlier this month.
Sofpironium Bromide is a gel that aims to treat primary axillary hyperhidrosis, a medical condition that results in excessive underarm sweating.
In the deal struck with Nasdaq-listed Brickell Biotech Inc (NASDAQ: BBI), Botanix agreed to purchase all of the US pharmaceutical company’s interests in the drug for an upfront payment of US$3 million plus an additional US$2 million if a positive response is received from the US Food and Drug Administration (FDA) after a new drug application (NDA) filing.
The terms of the agreement will also see Botanix receives services from Brickell to assist in this NDA filing and approval of the asset.
FDA filing planned for later this year
Botanix considers Sofpironium Bromide to be a significant opportunity for the company, as a de-risked asset with positive phase 3 trial data and attractive acquisition terms, which also complements the company’s existing pipeline of dermatological treatments for indications including acne, rosacea and dermatitis.
In a presentation for Botanix’s investor roadshow this week, the company said the NDA approval filing is being planned for the second half of 2022.
Anticipating a rapid pathway to approval and revenue, the company has estimated FDA approval and commercial manufacturing for launch of the medication could occur around the second half of 2023.
Drug development timeline
Botanix also provided an update on other products in its drug development pipeline, noting a phase 1b/2 study of its drug BTX 1702 on rosacea and a canine study of BTX 1204A on canine atopic dermatitis are both nearing completion of patient recruitment.
Completion of the BTX 1702 rosacea study will inform the final design for a phase three BTX 1503 trial on moderate to severe acne.
In addition, a phase 2 antimicrobial study evaluating BTX 1801 is preparing to launch in the 2022 second quarter, targeting nasal decolonisation of Staph (a nasal bacterium) in patients undergoing haemodialysis to reduce the incidence of life-threatening blood stream infections.