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Island Pharmaceuticals Raises $9m to Fund Clinical Development as FDA Approves Galidesivir Pathway

Antiviral drug development company Island Pharmaceuticals (ASX: ILA) has received guidance from the US Food and Drug Administration (FDA) confirming the validity of its proposed animal model and outlining the final steps needed to progress lead candidate galidesivir toward approval under the specialised Animal Rule pathway.

The FDA provided clear regulatory alignment on the use of the Angola strain of Marburg, the cynomolgus macaque model and the viral challenge dose—all core elements that underpin Animal Rule development.

Island said the three elements are traditionally the hardest for companies to secure and the confirmation represents a major de-risking milestone for the drug’s development.

The FDA has defined a two-stage clinical development pathway for galidesivir, enabling Island to move into short-term dose optimisation and pharmacokinetic studies followed by a time-to-dose study to determine the optimal treatment window post-infection of high-priority viral threats such as including Ebola, Marburg, MERS, Zika, and Yellow fever.

Medical Counter-Measures

Island will conduct the studies on a limited number of non-human primates utilising its first manufactured batch of galidesivir.

The resulting data will be submitted to the FDA to support approval under the Animal Rule.

The achievement would provide a defined regulatory pathway for medical counter-measures targeting high-consequence viral threats and may also unlock eligibility for US government procurement, including potential inclusion in the strategic national stockpile.

Approval would also entitle Island to a priority review voucher, considered to be a highly-valuable regulatory incentive which highlights the commercial potential associated with the program.

Cornerstoned Capital Raising

Island has announced a $9 million private placement to fund the two-stage clinical development pathway for galidesivir and a subsequent new drug application with the FDA.

The new funding has been cornerstoned by a US-based family office, with additional commitments from a select group of local and international investors.

Island will issue 25.7 million new ordinary shares priced at $0.35 each, representing a 10% discount to the last traded price and a 17.94% discount to the 15-day volume weighted average price of $0.4265.

“Following the FDA’s confirmation of the Animal Rule development pathway, we now have a clearly-defined and executable route to approval and this funding ensures we are fully resourced to move forward without delay,” managing director Dr David Foster said.

“The placement provides financial strength to complete our two-stage development program and manufacture additional supplies of galidesivir to meet clinical development and commercial readiness objectives.”

​​​​​​​Source: SmallCaps