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US Biopharma to Launch Phase 3 Trial in Bacterial Vaginosis
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Daré Bioscience's study, its prospects and the indication's U.S. market opportunity are discussed in a ROTH Capital Partners report.

In a May 15 research note, ROTH Capital Partners analyst Yasmeen Rahimi reviewed why the outlook is positive for Daré Bioscience Inc.'s (DARE:NASDAQ) DARE-BV1, a treatment candidate for bacterial vaginosis.

Rahimi outlined the next steps for DARE-BV1.

This biopharmaceutical firm based in San Diego, Calif., intends to launch a pivotal Phase 3 trial of DARE-BV1 in July, aiming to highlight it as a firstline treatment option. Topline study data should be available by year-end 2020. Due to the fast track status of DARE-BV1, Daré only needs to complete one Phase 3 study before filing a new drug application for it with the U.S. Food and Drug Administration.

The study will involve 250 women with bacterial vaginosis who will be assessed at their day 21–30 visit. The endpoint is clinical cure rate, measured using Amsel criteria.

Subsequently, Daré intends to take 219 patients from the Phase 3 study who experienced a cure of their bacterial vaginosis, whether from DARE-BV1 or metronidazole, and evaluate them in an extension study. They will not get further treatment but will be assessed at both 30 and 60 days after enrollment in this add-on study for duration of treatment response and thus, potential recurrence.

Rahimi explained that Daré's existing data on DARE-BV1 "is setting up the Phase 3 study for success." Results from a prior proof of concept study showed that one administration of DARE-BV1 resulted in an 86% clinical cure rate (and 57% bacteriological, or Nugent, cure rate and 57% therapeutic cure rate) at the first post treatment follow-up on day 7–14. Further, 92% of the women with a clinical cure at that day 7–14 visit did not show a recurrence of vaginosis at their second visit on day 21–30.

Also, the cure rate from the placebo in previous studies was low, at 5–10%. This means that "there is an excellent chance that the proof of concept results can translate into a larger study, especially since the treatment cure rates would be compared to a low placebo rate, which would show a clear treatment benefit," noted Rahimi.

She indicated that Daré has the funding needed for this Phase 3 bacterial vaginosis program and for advancing other clinical assets. This is due to the recent purchase agreement the company signed, which can yield up to $15 million for the biopharma over three years. "This transaction grants Daré security and stability, especially during the uncertainty caused by the COVID-19 pandemic," Rahimi added.

Rahimi highlighted that bacterial vaginosis is an undervalued market opportunity in the U.S. and explained why. With bacterial vaginosis being highly prevalent and the most common cause of vaginitis in U.S. women, the market size in the United States is 21 million. Additionally, the recurrence rate is high, as high as 60–80%, within three to four months after the initial infection. As such, a great unmet need exists for a bacterial vaginosis treatment that prevents recurrence.

Finally, Rahimi purported that Daré's partnership with Health Decisions "can leverage the clinical research organization's (CRO's) expertise in women's health to accelerate clinical development and cut costs. The CRO has extensive expertise with women's health assets, especially those related to contraception and fertility. In contraception, for example, Health Decisions has executed 40-plus clinical studies. That company "is the perfect match for Daré and will be key for the clinical execution and advancement of assets in Daré's women's health pipeline," the analyst commented.

ROTH has a Buy rating and a $4 per share price target on Daré, the stock of which is now trading at about $1.05 per share.


1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
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Disclosures from ROTH Capital Partners, Daré Bioscience Inc., Company Note, May 15, 2020

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.

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.

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