Island Pharmaceuticals (ILA: $0.195) announced that its anti-Dengue drug candidate, ISLA-101, had met its Phase 2a primary endpoint of reduction in blood virus levels. Its Safety Review Committee (SRC) had found ISLA-101 administration to be safe, achieved appropriate blood concentrations of drug and virus, and should proceed to Phase 2b.
Dubbed "PROTECT", the Phase 2 trial is a challenge study, infecting healthy individuals with an attenuated (weakened) virus. This Phase 2a randomised four volunteers 3:1 (dosed: placebo), and dosed subjects prophylactically (before infection).
The company remains blinded and will not have access to full data until the Phase 2b readout next April. The Phase 2b will randomise subjects 8:2 and treat the volunteers therapeutically (post-infection). If the trial is successful, Island intends to meet with the FDA to review procedures for a potential Phase 3 study. CEO Dr. David Foster indicated that the company was willing to take ISLA-101 to market alone but will consider all options and opportunities.
Island Pharmaceuticals is looking to acquire repurposed drugs to suit underserved diseases. Ideally, these candidates would have passed Phase 1, have open Investigational New Drug (IND) applications, come with non-dilutive financing, and/or have Priority Review Voucher (PRV) eligibility. ISLA-101 is one such example, but Island also bought an option to purchase a very similar broad-spectrum antiviral, Galidesivir, which is currently undergoing due diligence.
ISLA-101 has been tested in 45 human studies for many indications, and in many animal models. The company acquired the asset from Monash University, which found that it exhibited "phenomenal biochemistry" in preclinical studies. Simultaneously, a Harvard research group published nearly identical results, substantially de-risking the small molecule.
Island has close ties to the US Department of Defence. The US Army provided an attenuated Dengue virus for PROTECT, as well as granting Island data from prior studies. The Phase 2a results occurred faster than expected, due to efficiencies with data collection and review by the Safety Review Committee.
Galidesivir's owner, BioCryst, had also received US$44 million from medical countermeasure departments NIAID and BARDA, to develop Galidesivir against Yellow Fever.
Island Pharmaceuticals raised an oversubscribed A$3.5 million in October, which will fund all activities – including a Galidesivir acquisition and due diligence – until well past the PROTECT April readout. Island Pharmaceuticals is capitalised at $30 million.
Bioshares recommendation: Speculative Hold Class B
Disclaimer:
Information contained in this newsletter is not a complete analysis of every material fact respecting any company, industry or security. The opinions and estimates herein expressed represent the current judgement of the publisher and are subject to change. Blake Industry and Market Analysis Pty Ltd (BIMA) and any of their associates, officers or staff may have interests in securities referred to herein (Corporations Law s.849). Details contained herein have been prepared for general circulation and do not have regard to any person’s or company’s investment objectives, financial situation and particular needs. Accordingly, no recipients should rely on any recommendation (whether express or implied) contained in this document without consulting their investment adviser (Corporations Law s.851). The persons involved in or responsible for the preparation and publication of this report believe the information herein is accurate but no warranty of accuracy is given and persons seeking to rely on information provided herein should make their own independent enquiries. Details contained herein have been issued on the basis they are only for the particular person or company to whom they have been provided by Blake Industry and Market Analysis Pty Ltd. The Directors and/or associates declare interests in the following ASX Healthcare and Biotechnology sector securities: Analyst MP: 1AD, ACR, AVR, CGS, CUV, CYC, DXB, IMM, LBT, MX1, OPT, NEU, PAB, PXS,RNO,SOM. These interests can change at any time and are not additional recommendations. Holdings in stocks valued at less than $100 are not disclosed.
