Motif Bio announced that the FDA has accepted for filing the New Drug Application for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections. This means that the FDA has determined that the application is sufficiently complete to perform a substantive review. The NDA has been granted Priority Review, and the FDA has set a target decision date under the Prescription Drug User Fee Act of February 13, 2019.
Motif Bio announced that the company has received a Notice of Allowance from the United States Patent and Trademark Office for United States Patent Application Nos. 15/586,021 and 15/586,815. The claims relate to the use of iclaprim to treat patients with bacterial infections, including but not limited to acute bacterial skin and skin structure infections, hospital-acquired bacterial pneumonia and Staphylococcus aureus lung infections in patients with cystic fibrosis. The two method of use patents will expire in November 2037.
Motif Bio initiated with an Outperform at Northland. Northland initiated Motif Bio with an Outperform and $25 price target given high expectations that Iclaprim will receive FDA approval for ABSSI, which should serve as a catalyst for shares.
Motif Bio announced the initiation of a rolling submission of a New Drug Application, or NDA, to the FDA for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure infections, or ABSSSI,. The NDA submission is expected to be completed during the second quarter of 2018. The company has also received correspondence from the FDA that a small business waiver has been granted for the NDA application fee which is due upon submission of an NDA under the Prescription Drug User Fee Act, or PDUFA. As a result, Motif did not have to pay the $2.4M application fee for this NDA submission.
Motif Bio provided an update on the status and timeline for submission of its New Drug Application, or NDA, to the FDA, for its targeted, Gram-positive investigational antibiotic, iclaprim, for the treatment of acute bacterial skin and skin structure infections, or ABSSSI. In consultation with its advisers, the company has decided that in order to ensure a complete and high quality submission, it would be prudent to take additional time and consequently, the company now expects that the NDA will be submitted to the FDA during Q2.
Motif Bio announced that Robert Dickey IV has informed the company of his intention to resign from his role as CFO. A search process for a new CFO has commenced and Jonathan Gold, currently a Non-executive Director of the company, has agreed to serve as interim CFO. Dickey IV will continue to serve in an advisory capacity to ensure a smooth transition.
Motif Bio announced that the results from REVIVE-1, a global Phase 3 clinical trial evaluating the investigational drug candidate iclaprim in patients with acute bacterial skin and skin structure infections, have been published in the peer-reviewed journal, Clinical Infectious Diseases. The positive topline results from this study were announced in April. In the intent-to-treat patient population, 80.9% of patients treated with iclaprim and 81% of patients treated with vancomycin achieved the primary endpoint of early clinical response, defined as a greater than or equal to 20% reduction in lesion size compared with baseline, at the early time point, 48 to 72 hours after the start of administration of the study drug. Non-inferiority thus was confirmed for iclaprim compared to vancomycin. 80% of diabetic patients in the iclaprim group and 74% of diabetic patients treated with vancomycin achieved ECR at ETP. 83% of iclaprim-treated patients with moderate/severe renal impairment and 75% of vancomycin-treated patients with moderate/severe renal impairment achieved ECR at ETP. Iclaprim was well tolerated in the study. Iclaprim has been designated as a Qualified Infectious Disease Product by the FDA. This designation includes Priority Review upon acceptance of a New Drug Application, and, if approved, it is anticipated that iclaprim will be eligible to receive 10 years of market exclusivity in the U.S. from the date of approval. The FDA has also granted Fast Track designation for iclaprim. Motif Bio plans to submit an NDA by the end of 1Q18.