Antisense paves way for IND for MS drug
Antisense Therapeutics (ASX:ANP) has received a positive response from the US FDA regarding its intention to conduct phase IIb trials of drug candidate ATL1102 in multiple sclerosis (MS).
The company filed a notice that it plans to initiate longer-term human trials as part of an Investigational New Drug application with the US FDA.
The agency has provided Antisense with supportive guidance in the form of a pre-IND assessment of the company’s development strategy for the drug.
Antisense CEO Mark Diamond said the FDA’s response is “an important step in moving ATL1102 forward into late-stage clinical development [and therefore capitalising] on the substantial development and investment made to date on this key project asset”.
He said Antisense is on the search for a pharmaceutical partner to help drive ATL1102’s further development.
Last month, Antisense launched an up to $2.5 million capital raising to help fund the FDA interactions regarding the upcoming trial, as well as partnership efforts for another candidate - ATL1103 - in growth disorder acromegaly.
The company also recently revealed that the phase IIa trial of ATL1102 met its primary end point of a statistically significant reduction in the cumulative number of new active brain lesions in patients taking ATL1102 compared to a placebo.
Antisense Therapeutics (ASX:ANP) shares were trading unchanged at $0.105 as of around 2 pm on Tuesday.
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