The ID Pipeline: FDA Activity From the Week of August 11, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of August 11, 2019.

Nabriva to Resubmit NDA for Fosfomycin for Injection for the Treatment of Complicated UTIs

On Friday, August 16, 2019, Nabriva Therapeutics announced plans to resubmit a New Drug Application (NDA) to the FDA for fosfomycin for injection (Contepo™) following the receipt of final Type A meeting minutes from the agency. The agent is for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis.

The company initially received a Complete Response Letter earlier this year from the FDA stating that Nabriva needed to address issues related to facility inspections and manufacturing deficiencies before the NDA would be approved.

“I am pleased that we had the opportunity to clarify the information needed to address the observations in the CRL. With the official minutes from the FDA in hand, we have identified a path forward for resubmission of the CONTEPO NDA in the near future. We look forward to the opportunity to bring this important treatment to patients as quickly as possible and providing clinicians an urgently needed early and appropriate therapeutic option to manage patients at risk of resistant infections with limited available treatment options for cUTIs,” Ted Schroeder, CEO of Nabriva Therapeutics, said in a press release.

The full press release is available here.

Update on CytoDyn's HIV Dose Escalating Monotherapy Trial With Leronlimab

On Wednesday, August 14, 2019, CytoDyn Inc. provided an update on its HIV dose escalating monotherapy trial with leronlimab (PRO 140).

According to the company, participants received dosages of 350 mg, 525 mg, or 700 mg of leronlimab once a week (229, 201, and 134 patients, respectively), and approximately 150 exhibited sustained viral suppression at 1 year of monotherapy. According to the update, the rate of viral load suppression post-10 weeks of monotherapy was 68%, 94%, and 85% with 350 mg, 525 mg, and 700 mg, respectively. The failure criteria post-10 weeks was three increasing viral loads over 50 cp/mL or one viral load over 1000 cp/mL.

"These results position us well for our upcoming face-to-face meeting with the FDA regarding our pivotal monotherapy trial protocol,” CytoDyn President and CEO Nader Pourhassan, PhD, said in a press release. "Even more impressive is the long-term durability of the antiviral response in some patients in our other trials, with 6 patients reaching 3 years successfully on monotherapy and another 4 patients nearing the 5-year mark for suppressed viral load...Recent data suggests that the receptor occupancy test being fine-tuned by Dr. Bruce Patterson may effectively identify potential responders to monotherapy at the time of screening, thereby potentially raising the success rate in the monotherapy program."

The full press release is available here.

Enrollment Complete for Novan Inc's Phase 3 Molluscum Contagiosum Trials

On Tuesday, August 13, 2019, Novan, Inc. announced it has completed enrollment in the B-SIMPLE phase 3 pivotal trials for SB206 for the treatment of molluscum contagiosum.

Approximately 680 patients who have between 3 and 70 molluscum lesions at baseline have been enrolled in the trials, which will assess the efficacy of the 12% once-daily SB206 gel. Phase 2 trials demonstrated a clear treatment effect on the complete clearance of molluscum lesions at Week 12.

“The pace by we which we fully enrolled these pivotal studies demonstrates the underlying demand and unmet medical need that exists for molluscum patients and their caregivers,” Elizabeth Messersmith, PhD, senior vice president and chief development officer, said in a press release. “The Novan team, along with the investigators and program coordinators, have done an exceptional job in achieving this important milestone. We look forward to sharing the top line results at the appropriate time.”

The full press release is available here.

FDA Grants QIDP Designation to Daré Bioscience for Bacterial Vaginosis Treatment

On Monday, August 12, 2019, the FDA granted Qualified Infectious Disease Product (QIDP) designation to Daré Bioscience Inc. for DARE-BV1, a novel thermosetting hydrogel containing clindamycin phosphate 2% for the treatment of bacterial vaginosis (BV) in women.

“Receiving QIDP designation for DARE-BV1 for the treatment of BV is validation that BV is a serious infection for which current treatment options are inadequate. Our novel thermosetting hydrogel technology delivering clindamycin has the potential to become a powerful new treatment option for health care providers struggling to adequately address and resolve this persistent vaginal infection,” Sabrina Martucci Johnson, president and CEO of Daré Bioscience, said in a press release. “With clinical cure rates of currently approved products in the range of 37-68% and prevalence of BV in the U.S. estimated to be over 21 million among women ages 14—49, there is significant need for a more effective treatment. We believe the unique thermosetting hydrogel formulation characteristics of DARE-BV1 may result in better antibiotic delivery to the vaginal infection, which can lead to better clinical outcomes.”

The full press release is available here.