With a deterioration in capital markets, Antisense Therapeutics (ANP: $0.86) has adjusted its clinical program in Duchenne's Muscular Dystrophy with its lead drug candidate ATL1102. The company had previously intended to conduct a potentially pivotal Phase IIb/III study in 114 patients. That has now been changed to a Phase IIb program that will seek to enroll 45 subjects.
Last year Antisense raised $22.6 million at $0.24 per share in a placement ($20 million) and a rights issue ($2.6 million). The company was seeking to raise up to $16.8 million in the rights issue. However, with the shortfall, it has needed to adjust its clinical program.
Antisense will now conduct a Phase IIb program that is expected to start late this year or early next year. The benefit of reducing the trial size is that study results are expected to be received earlier. Recruitment is expected to be completed early Q3 next year with dosing lasting for six months. On this timeline results should be available in Q1 2024.
Previously the company had planned on a blinded, interim futility analysis by the Data Safety and Monitoring Board after the first 48 patients had been treated. However, this would not have provided efficacy data, just a recommendation on whether to continue the study. With the revised program efficacy data is expected in about 18 months.
The company will need to seek some additional capital towards the end of next year, around $5 million, to get to the data readout point.
The Phase IIb study will be conducted at 13 sites across Australia and Europe with the Royal Children's
Hospital (where an earlier study was completed) expected to participate. The same CRO, Paraxel, will
coordinate the trial. Site investigators have already been selected.
Treatment will involve a weekly subcutaneous injection of ATL1102 at doses of 25 mg or 50 mg. The Phase Ib study looked at 25 mg weekly injections, with positive improvements in muscle strength in the boys involved in the study. The company will use mobile nurses to administer the therapy at home to many of the patients in the study.
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Patients in the study will be incentivised by being offered six months of treatment with ATL1102 after their six-month study participation. Antisense CEO Mark Diamond said there is very high interest from clinicians in the study with patients in Europe already identified.
If the data from the study is compelling, Antisense may look at an accelerated approval pathway, with 12-month safety data on hand from the six-month extension phase of the program.
Antisense is capitalised at $63 million with $19 million in cash at the end of June.
Bioshares recommendation: Speculative Buy Class B
Correction to original article: Antisense Therapeutics expects recruitment into its Phase IIb trial to be completed in early Q3 2023 with topline results in Q1 2024.
