Biopharma's Positive FDA Meeting Outlines Path Forward for Trial

The Life Sciences Report |

Source: Streetwise Reports   09/11/2018

In a Sept. 6 research report, analyst Yasmeen Rahimi with ROTH Capital Partners relayed that Daré Bioscience Inc. (DARE:NASDAQ) "secured a win" during its recent Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the biopharmaceutical company's upcoming Phase 2b trial evaluating topical sildenafil as a treatment for female sexual arousal disorder (FSAD).

As Daré had hoped, the FDA approved its use, as two primary efficacy endpoints in its study, of patient-reported outcome measurements that differ from those the agency recommended in its 2016 Draft Guidance from 2016, which were heightened sexual satisfaction and arousal.

The endpoints the company will now use are improvement in personal distress and genital sensation of arousal.

This change matters to Daré, Rahimi noted, because the FDA-recommended patient outcomes pertain to hypoactive sexual desire disorder, or a lack of sexual desire, whereas the new endpoints are better suited for patients with FSAD, as they are unable to reach or maintain sexual arousal. "In our view, co-primary endpoints for improvements in arousal and distress align more closely with FSAD and the intended biological mechanism of sildenafil," he added.

Also during the meeting, Daré and the FDA agreed upon a design for the Phase 2b study of topical sildenafil in FSAD. It will consist of two components. The first will be a "content validity study," in which patients will not receive the drug. Rather, their "comprehension of patient-reported arousal and distress measurements will be tested to isolate assessments most important and relevant" to them. This part is already underway.

Following completion of part one, Daré will meet again with the FDA to review and ensure the patient-reported outcomes will still work in the study's next phase. The meeting is likely to occur in 2019.

For that second study part, which is to take place at home and last 12 weeks, 450 patients will be enrolled and divided evenly between three cohorts: those getting dose A, those getting dose B and those getting a placebo. The objective of the study is to show efficacy in pre and postmenopausal women. "It will also incorporate inclusion/exclusion criteria that fit the FSAD diagnosis definition," Rahimi wrote.

ROTH has a Buy rating and a $6 per share 12-month target price on Daré, whose stock is currently trading at around $1.00 per share.

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Disclosures from ROTH Capital Partners, Daré Bioscience Inc., Flash Note, Sept. 6, 2018

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Daré Bioscience, Inc.

ROTH makes a market in shares of Daré Bioscience, Inc. and as such, buys and sells from customers on a principal basis.

Shares of Daré Bioscience, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.

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Within the last twelve months, ROTH has managed or co-managed a public offering for Daré Bioscience, Inc.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: DARE:NASDAQ, )

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