The ID Pipeline: FDA Activity From the Week of June 2, 2019

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of June 2, 2019.

CytoDyn Inc. to Meet with FDA to Discuss Pivotal Monotherapy Trial for Leronlimab

On Friday, June 7, 2019, CytoDyn Inc. announced it will meet with the FDA to finalize the protocol for a pivotal monotherapy trial for leronlimab (PRO 140), an investigational humanized IgG4 mAb that blocks CCR5.

To date, leronlimab has successfully completed 9 clinical trials in more than 700 people, and demonstrated the ability to significantly reduce or control HIV viral loads in humans.

“We believe there are over 130,000 individuals using a currently approved drug for the prevention of HIV. The side effects and long-term morbidities are well known, which include, among others, kidney and liver complications, bone density issues, headaches, abdominal pain, and weight loss. Based upon leronlimab’s mechanism of action, our collaborating partners are very excited to initiate a prevention study, and we share their enthusiasm about the possibilities,” Nader Pourhassan, PhD, CytoDyn president and CEO, said in a statement. “There is only 1 self-injectable humanized monoclonal antibody, leronlimab, which is near approval that targets CCR5. Leronlimab is one dose-a-week, sub-cutaneous injection that has all the characteristics of potentially becoming a major therapeutic contributor to the field of HIV and perhaps in cancer and auto-immune diseases. The support of our shareholders has enabled our Company to advance leronlimab towards an anticipated FDA approval, in addition to exploring many opportunities in various cancer indications, any of which could offer significant benefits and rewards for patients throughout the world and for all of our stakeholders.”

The full press release is available here.

Iclaprim's Path Forward: Motif Bio Makes Announcement Following Receipt of FDA Minutes

On Thursday, June 6, 2019, Motif Bio announced its next steps for iclaprim after the FDA issued a Complete Response Letter to the company in February over concerns about liver toxicity.

Motif Bio said it had received the minutes from a May 3, 2019, Type A meeting with the FDA, which indicated the need for an additional clinical trial ahead of marketing approval for iclaprim for the treatment of acute bacterial skin and skin structure infections.

“We now have confirmation of what will be required for a path forward for iclaprim," Dr. Graham Lumsden, CEO of Motif Bio, said in a statement. "We intend to meet with the Agency to agree on the specific requirements of the trial, which will enable us to estimate its size and scope and, therefore, the costs and funding requirements. In parallel, we expect to continue our discussions with potential commercial partners and will determine the best options for funding the trial once we have clarity from the FDA.”

The full press release is available here.

FDA Issues Approval to Emergent BioSolutions for Change in Storage Conditions, Transfer of Manufacturing for Cholera Vaccine

On Tuesday, June 4, 2019, Emergent BioSolutions Inc. received FDA approval of the Prior Approval Supplement (PAS) that was submitted for its oral cholera vaccine, Vaxchora.

The PAS allows for a change in storage conditions of Vaxchora from frozen to refrigerated at 2-8°C. It also allows for the transfer of bulk drug substance manufacturing from the company's product development facility in San Diego to its facility in Berlin, Switzerland.

“Emergent is pleased with this FDA approval that enables a more robust supply chain process for our oral cholera vaccine and maximizes capacity utilization of our manufacturing facilities,” Sean Kirk, executive vice president, manufacturing and technical operations at Emergent BioSolutions, said in a statement. “This development positions the company to expand into new markets as we prepare for European launch in 2020.”

The full press release is available here.

FDA Advisory Panel Recommends Approval of TB Alliance Tuberculosis Treatment

On Tuesday, June 4, 2019, an FDA advisory panel voted 14-4 to recommend approval of a tuberculosis treatment in development by TB Alliance.

The treatment for drug-resistant tuberculosis, pretomanid, would be part of a 3-drug combination regimen, along with Johnson & Johnson's bedaquiline and linezolid. The FDA is not bound to follow the advice of its independent advisory panels, but usually does so, according to Reuters.

"The FDA granted priority review for pretomanid and the marketing application is based on interim data from the first 45 patients in an ongoing study with a total of 109 participants," the news outlet reported.

The full article is available here.

Novan, Inc. Announces First Patient Dosed in Phase 3 Molluscum Program

On Tuesday, June 4, 2019, Novan, Inc. announced that the first patient in its B-SIMPLE (Berdazimer Sodium In Molluscum Patients with Lesions) phase 3 program for molluscum contagiosum had been dosed.

There are currently no FDA approved therapies for molluscum, a highly contagious viral infection of the skin that is common in children. The B-SIMPLE program features 2 multi-center, randomized, double-blind, vehicle-controlled studies, B-SIMPLE1 and B-SIMPLE2, each of which will enroll approximately 340 patients in order to evaluate the efficacy and safety of SB206 12% once daily compared with placebo.

“Molluscum contagiosum is a terribly frustrating condition for affected children and their parents. Despite the self-limited nature of the skin infection, spontaneous resolution can take quite a while. Fears regarding potential viral transmission to others, secondary infection of lesions and scarring can create a sense of treatment urgency,” Robert A. Clifford, MD, FAAP, managing partner of Coastal Pediatric Associates and an investigator on the program, said in a statement. "Because of this, I am delighted to be participating in the B-SIMPLE program and am eager to offer this study to patients seeking a potential solution for their molluscum lesions.”

The full press release is available here.