TICKERS: ZYNE

Good Epilepsy Data from Zynerba Pharmaceuticals Would Set Stage for Pivotal Trials

Source:

Maxim Group noted that data from Zynerba's Phase 2 proof of concept trial will be released in the third quarter; positive data would set the stage for Phase 3 trials.

Zynerba Pharmaceuticals Inc. (ZYNE:NASDAQ) expects to release data in the third quarter from its Phase 2 STAR (Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy) trial for ZYN002 in adult refractory focal seizures. In the trial, according to Maxim's March 28 report, the patients "have been randomized to receive 195mg, 390mg, or placebo. The primary end point is median percentage change in seizure frequency over the 12-week treatment period."

"Of 110 patients who have completed the STAR 1 study, 106 patients have enrolled into STAR 2, an open label long-term safety and tolerability study of ZYN002 for up to 52 weeks. After completion of Phase II, the company expects to meet with the FDA to initiate Phase III in the U.S. in 1H18." Maxim stated.

If the STAR 1 results are favorable, Maxim states that it "could count as one of two pivotal trials necessary for approval. . .for focal seizure only, FDA's recent guideline allows for the use of results from the two pivotal trials for children four years and up, requiring only PK and drug interaction study; meaning, a monotherapy trial is not necessary for an indication in children four years and up."

Maxim sees Zynerba as a "tangential play on GW Pharma, with a differentiated mode of delivery (transdermal vs. oral) of the same CBD (cannabidiol). ZYN002 has a better safety and bioavailability profile, and is a synthetic (vs. plant based), which means higher margins and better quality control. Zynerba is also targeting a much larger indication in Epilepsy vs. orphan drug indications for GW Pharma."

Maxim has a 12-month target price on Zynerba of $32. The shares are now trading around $22.

Want to read more Life Sciences Report articles like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see recent articles and interviews with industry analysts and commentators, visit our Streetwise Interviews page.

Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. She owns, or members of her immediate household or family own, shares of the following companies mentioned in this article: None. She is, or members of her immediate household or family are, paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are sponsors of Streetwise Reports: None. Streetwise Reports does not accept stock in exchange for its services. Click here for important disclosures about sponsor fees. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article, until one week after the publication of the interview or article.




Get Our Streetwise Reports Newsletter Free

A valid email address is required to subscribe