Olorofim is in a Phase IIb study that focuses on rare and resistant life-threatening invasive fungal infections, such as invasive aspergillosis (including azole-resistant strains), scedosporiosis, lomentosporiosis, fusariosis, scopulariopsosis and coccidioidomycosis.
Olorofim development getting millions in support.
F2G Ltd, a biotech company based in England, secured $60.8 million in a new financing round that will be used to support the company’s late-stage clinical programs for their novel antifungal agent Olorofim as well as organizational scale-up in preparation for potential commercialization.
Olorofim, the company’s lead candidate, is in a Phase IIb study that focuses on rare and resistant life-threatening invasive fungal infections, such as invasive aspergillosis (including azole-resistant strains), scedosporiosis, lomentosporiosis, fusariosis, scopulariopsosis and coccidioidomycosis, also known as Valley Fever. Last year, Olorofim was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration as a potential treatment of invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis. F2G said olorofim is the only antifungal agent to be awarded this designation. Earlier this year, Olorofim received Orphan Drug designation from the FDA. Olorofim has the potential to be the first truly novel mechanism antifungal therapy for nearly 20 years and represents a very significant market opportunity in an area of high unmet clinical need, the company said. Some estimates place the market for this at about $6 billion.
F2G Chief Executive Officer Ian Nicholson touted the financing as the latest in a string of positive events for the company.
“Following a successful year during which F2G has received FDA Breakthrough Therapy designation for Olorofim, as well as FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever), and QIDP designation in multiple fungal infections, today’s announcement is a significant milestone,” Nicholson said in a statement.
The financing round was led by Cowen Healthcare Investments and includes strong participation from existing investors Novo Holdings, Morningside Ventures, Brace Pharma Capital and Advent Life Sciences.
“I would like to thank our new and existing investors for their continued support. This financing marks the continued commitment of our shareholders and paves the way for the advanced development and potential approval of the first new antifungal treatment in 20 years, offering hope for patients with very limited treatment options and a high medical need,” Nicholson added.
As part of the financing arrangement, Naveed Siddiqi Partner at Novo Ventures, joins the F2G Board, replacing Martin Edwards who is retiring. Also joining the board are Tim Anderson, Managing Director at Cowen Healthcare Investments and Will West, Investment Advisor at Morningside Ventures.
“We are very encouraged by Olorofim’s emerging profile as a novel first in class anti-fungal agent to address these unmet medical needs. As the largest shareholder in the company since 2018, we are pleased to support F2G’s management team as they strive to bring this important new treatment rapidly to patients,” Novo Ventures Siddiqi said in a statement.
