News and Announcements
Antisense Therapeutics ATL1102 for MS Phase IIB IND Submitted to FDA for Approval
- Published June 26, 2017 12:00AM UTC
- Publisher Wholesale Investor
- Categories Company Updates
Antisense Therapeutics (ANP) has advised that the ATL1102 for Multiple Sclerosis (MS) Phase IIb IND application has been submitted to the US Food and Drug Administration (FDA) for its review.
KEY TAKEAWAYS:
- The Company’s IND application is for a Phase IIb trial in 195 R-MS patients.
- ANP is seeking to secure non-dilutive funding for the conduct of the Phase IIb trial from a US Federal Agency. IND clearance is required for receipt of such grant funding.
The ATL1102 Phase IIb IND application was composed of over 24,000 pages of ATL1102 information and data that required specific formatting and critical review by the Company’s US Regulatory Agents to ensure compliance with the FDA requirements for electronic IND submission.
Mark Diamond, CEO of Antisense Therapeutics said; “We are pleased to have reached this significant milestone in the development of ATL1102 for MS and look forward to the prospect of positive outcomes following the FDA’s review”.
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