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  • Island Pharmaceuticals (ILA) executes a one-off proposal with Sofgen for the manufacture of ISLA-101 for the upcoming Phase 2a PEACH clinical trial in dengue infected subjects
  • The new proposal contains a schedule that has ISLA-101 clinical material being manufactured in mid-August, a six-week delay from most recent estimates
  • The company was looking for alternative manufacturers after its prior manufacturer was unable to provide certainty required to plan effectively
  • The new timeline has been consolidated and the company expects the investigational new drug (IND) application to be filed in October with the trial commencing in November
  • Shares in Island Pharmaceuticals are down 18.8 per cent, trading at 13 cents as of 12:01 pm AEST

Antiviral drug development company Island Pharmaceuticals (ILA) has executed a one-off proposal with Sofgen for the manufacture of ISLA-101 for the upcoming Phase 2a PEACH clinical trial in dengue infected subjects.

The new proposal contains a schedule that has ISLA-101 clinical material being manufactured in mid-August, a six-week delay from most recent estimates.

The cost of the Sofgen proposal is US$134,000 (A$193,928), which is roughly in line with the prior manufacturing proposal of US$169,000.

Once manufactured, the material must undergo 30-day stability studies and release testing after which the investigational new drug (IND) application can be finalised and filed.

The company said that this step is crucial as it is required before the PEACH clinical trial can commence.

Commenting on the partnership, Island Pharmaceuticals CEO Dr David Foster said the Sofgen is a leader in its industry and has proven to be entrepreneurial and responsive as evidenced by their rapid response times.

“Moreover, we are excited by their presence in Latin America — given the prevalence of dengue fever in the region, which is anticipated to be a significant market for ISLA-101,” Dr Foster said.

“We take our manufacturing partners very seriously and would not have changed unless there was good reason to do so.

“We feel we’ve now got the right solution for our strong focus on moving ahead to enable the commencement of our clinical study.”

Island was looking for alternative manufacturers after its prior manufacturer was unable to provide certainty required to plan effectively and has since suggested additional delays.

The new timeline has been consolidated and the company expects the IND application to be filed in October with the trial commencing in November.

Shares in Island Pharmaceuticals were down 18.8 per cent, trading at 13 cents as of 12:01 pm AEST.

ILA by the numbers
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