The Antisense Therapeutics Limited (ASX: ANP) share price soared today without any news out of the company. It seems the market may have been a bit slow on the uptake and was responding to news released by the junior healthcare company earlier in the week. On Tuesday, Antisense released an announcement regarding a muscular dystrophy study.
The company provided an update on its meeting with the United States Food and Drug Administration (FDA) in relation to the inhibitor ATL1102. At close of trading today, the biotechnology company's shares were up 15.79% to 22 cents. This followed gains on Thursday's session as well.
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What's drove the Antisense share price higher?
The rise in Antisense shares followed the release earlier this week of the FDA's official minutes on the company's Type C guidance meeting.
According to the statement, the FDA has given the nod for Antisense to explore higher dosage limits of ATL1102 in future studies. This follows the recent data findings of Antisense's Phase II open-label study in Melbourne. A total of 9 Duchenne muscular dystrophy (DMD) patients received 25 milligrams of ATL1102 per week for 24 weeks.
Furthermore, Antisense said the FDA has accepted the company's proposed design of its Phase IIb/III study. The clinical trial will run for 52 weeks during which time participants will be assessed for muscle strength. The FDA also suggested Antisense submits a study protocol, outlining primary and secondary endpoints.
A 9-month monkey toxicology study will also be conducted into the effects of ATL1102. However, the FDA said once the animal study is at the report-writing stage, the Phase IIb/III human trial can begin.
Antisense is now consulting with US-based regulatory advisors regarding the next steps towards starting the Phase IIb/III human trial. In addition, the company is evaluating the cost and feasibility of the 9-month monkey study.
About Antisense and ATL1102
Founded in 2000, Antisense is focused on developing and commercialising antisense pharmaceuticals for patients suffering from rare diseases. Antisense is the non-coding DNA strand of a gene.
The company is developing ATL1102, an antisense inhibitor of the CD49d receptor, for DMD patients. Recently Antisense reported promising Phase II trial results, indicating a significantly reduced number of brain lesions in patients with relapsing-remitting multiple sclerosis.
DMD is a severe type of muscular dystrophy that primarily affects boys. According to Antisense, it occurs as a result of mutations in the dystrophin gene which cause a substantial reduction in, or absence of, the dystrophin protein.
Ongoing deterioration in muscle strength affects lower limbs, leading to impaired mobility, and can also affect upper limbs, leading to further loss of function and self-care ability.
Over the past 12 months, the Antisense share price has jumped by almost 230%. Antisense shares are also up by around 70% year to date.
