The ID Pipeline: FDA Activity From the Week of July 7, 2019


Here is a look at infectious disease-related US Food and Drug Administration news from the week of July 7, 2019.

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of July 7, 2019.

FDA Clears HOOKIPA Pharma's IND Application for HB-201 Clinical Trial to Treat HPV-Positive Cancers

On Thursday, July 11, 2019, HOOKIPA Pharma Inc. announced that the FDA cleared its Investigational New Drug Application for a phase 1/2 clinical trial of HB-201, a TheraT®-based immunotherapy for the treatment of human papillomavirus (HPV)-positive cancers.

The targeted start date for the phase 1/2 trial is the second half of 2019 with preliminary safety and efficacy data expected in late 2020 or early 2021.

"With the FDA’s clearance of our IND application we have achieved an important milestone advancing HB-201 into clinical development," Joern Aldag, HOOKIPA’s Chief Executive Officer, said. "We aim to prove that our technology platform can effectively super-charge the natural defense mechanisms in humans and deliver prevention or cure for the benefit of seriously ill patients.”

Read the full press release here.

Novan's B-SIMPLE Phase 3 Pivotal Trial Program Exceeds 50 Percent of Expected Patient Enrollment

On Thursday, July 11, 2019, Novan, Inc. announced it had exceeded 50 percent of expected patient enrollment in its phase 3 pivotal trials to evaluate topical nitric oxide product candidate SB206 for the treatment of molluscum contagiosum.

The B-SIMPLE phase 3 program comprises 2 multi-center, double-blind, randomized, vehicle-controlled studies, B-SIMPLE1 and B-SIMPLE2, to analyze the safety and efficacy of SB206 as a once-daily treatment option.

“Molluscum is a highly contagious skin disease with a clear and identifiable unmet medical need,” commented Elizabeth Messersmith, PhD, senior vice president and chief development officer of Novan. “We are pleased with the pace of enrollment and continue to work with our sites in order to help ensure the absolute highest quality in execution and operational discipline around all aspects of the trials and their progression.”

Read the full press release here.

Department of Defense Contract Awarded to SIGA Technologies to Develop Expanded Indication for Smallpox Treatment

On Monday, July 8, 2019, SIGA Technologies, Inc. announced it had received a multi-year contract from the US Department of Defense to work towards a potential label-expansion to use TPOXX® (tecovirimat) as post-exposure prophylaxis (PEP) of smallpox.

With an initial award of $12.4 million and a total contract value of up to $19.5 million, the deal will support manufacturing material for clinical trials, initial preparation for a human clinical safety study, and assembling regulatory filings that SIGA has designed with input from the FDA to evaluate the use of TPOXX for PEP.

“During our FDA Advisory Committee meeting in May 2018, several committee members emphasized the importance of evaluating the potential use of TPOXX not only to treat smallpox symptomatic infection, but also to treat patients with known smallpox exposure who have not yet developed symptoms,” said Phil Gomez, CEO of SIGA Technologies. “An expansion of the TPOXX label to include its use for PEP would provide greater flexibility to deliver TPOXX to those who might benefit from treatment during a potential outbreak. We have successfully collaborated with a number of U.S. government agencies in the development and approval of TPOXX for the treatment of smallpox, and are pleased to be working with DoD on these important studies.”

Read the full press release here.

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