Valneva Reports Successful Outcome of Phase 2 Run-In for its Lyme Disease Vaccine Candidate

World News: . []

Valneva has previously reported initial booster data and final Phase 1 follow-up data for VLA15, confirming that the vaccine candidate has a favorable safety profile and was immunogenic in all doses and formulations tested. VLA15 elicited an excellent anamnestic response following a booster vaccination in a time window of 12 to 15 months after initial primary immunization.

As part of the VLA15-201 run-in Phase, 120 subjects received one of three alum adjuvanted dose levels of VLA15 (90µg, the high dose from Phase 1, 135µg or 180µg) or placebo. The DSMB has reviewed safety data from those subjects and has cleared the 135µg and 180µg dosage levels for further investigation in the main study phase.

Valneva has commenced preparations to initiate a further Phase 2 study (VLA15-202) to evaluate an alternative immunization schedule. The Company expects this study to commence in the third quarter of this year.

Preliminary Phase 2 results (primary endpoint) are anticipated – as previously announced – mid-2020.

VLA15-201 is the first of two planned, parallel Phase 2 studies. It is a randomized, observer-blind, placebo controlled trial conducted at trial sites in the US and Europe. In the run-in Phase, 120 subjects received one of three dosage levels of VLA15, or placebo. Following review of safety data by an independent Data Safety Monitoring Board, 450 subjects in the main study phase will receive one of two selected dose levels of VLA15 (180 subjects each), or placebo (90 subjects). VLA15 will be tested as alum adjuvanted formulation and will be administered intramuscularly in three injections, given one month apart at Days 1, 29 and 57. Subjects will be followed for one year, with the main immunogenicity readout one month after the third immunization on Day 85 (Primary Endpoint). The study is enrolling healthy adults 18 to 65 years of age. Study centers will be located in areas where Lyme disease is endemic; subjects with a cleared past infection with , the bacteria that cause Lyme disease, will also be enrolled.

This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing and completion of research, development and clinical trials for product candidates, the ability to manufacture, market, commercialize and achieve market acceptance for product candidates, the ability to protect intellectual property and operate the business without infringing on the intellectual property rights of others, estimates for future performance and estimates regarding anticipated operating losses, future revenues, capital requirements and needs for additional financing. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of their in the future. In some cases, you can identify forward-looking statements by words such as "could," "should," "may," "expects," "anticipates," "believes," "intends," "estimates," "aims," "targets," or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. Valneva is providing the information in these materials as of this press release, and disclaim any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

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Globe Newswire: 16:50 GMT Wednesday 12th June 2019

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