The Antisense Therapeutics Limited (ASX: ANP) share price is surging today after the company released a positive report regarding Phase II trials for one of its drugs with the United States Food and Drug Administration (FDA).
The Antisense share price is up 7.5% at the time of writing, trading at 21.5 cents per share.
Antisense is an Australian publicly listed biotechnology company and drug manufacturer, developing and commercialising antisense pharmaceuticals for large unmet markets in rare diseases.
Its products are in-licensed from a US-listed company, Ionis Pharmaceuticals, an established leader in antisense drug development.
In medical parlance, antisense refers to drugs that inhibit the RNA strand of human DNA, preventing human genes from undertaking the purpose that they are genetically programmed to perform.
This is a particularly effective way of combatting serious genetic disorders, and in Antisense Therapeutics’ case, it’s currently tackling muscular dystrophy.
Antisense’s FDA update
Today, Antisense advised that its guidance meeting with the FDA was held to discuss the further development of the company’s trial drug, called ATL1102, in preventing Duchenne muscular dystrophy (DMD), in the US.
Antisense expects to provide further details about the meeting to its investors, after it receives the official minutes of the meeting from the FDA in late May 2021.
Antisense said the meeting was constructive and provided clarification on a path towards initiating a Phase IIb/III study in the US. Non-clinical requirements for trialling its drug is to be “further reviewed and agreed with the FDA to assess if and how they may impact on the timing of clinical study initiation”.
The feedback will be reviewed by Antisense’s internal team and incorporated into its global clinical development and commercialisation plans.
What management said
Antisense Therapeutics CEO Mark Diamond said Antisense was already acting on the meeting.
Based on the guidance meeting with the FDA, together with prior feedback from EMA and world-leading DMD experts, we are reassured that the data from our Phase II study is encouraging and that it is reasonable and appropriate to advance the program towards potentially pivotal clinical studies.
It is our goal to bring this medication to as many DMD patients worldwide as possible.
Antisense share price snapshot
The Antisense share price has been rising across the board, up 65% so far in 2021 and 347% higher over the past 12 months.