Trimesta (estriol oral) / Theriva Bio - LARVOL DELTA

A combination trial of estriol plus glatiramer acetate in relapsing-remitting multiple sclerosis: Effect on disabilities (ACTRIMS-ECTRIMS 2014) - Presentation time: 12.09.2014, 08:15-09:15; Abstract #FC3.3; P2, N=158; NCT00451204; "After 24 months of treatment, test scores remained high in the estriol plus glatiramer acetate group, while scores in the placebo plus glatiramer acetate group also improved....Trends for improvement in the Expanded Disability Status Scale (EDSS) were seen at 24 months in the estriol plus glatiramer acetate group, but not in the placebo plus glatiramer acetate group."

P2 data • Multiple Sclerosis

Synthetic Biologics announces issuance of U.S. patent covering combination of Estriol and Copaxone for multiple sclerosis (Synthetic Biologics Press Release) - "Synthetic Biologics...announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,372,826 entitled, Estriol Therapy for Multiple Sclerosis and Other Autoimmune Diseases, to the Regents of the University of California which includes claims to the use of the Company's drug candidate, Trimesta™ (oral estriol), in combination with glatiramer acetate injection (Copaxone®)...the clinical results of this combination therapy after the relapsing-remitting multiple sclerosis patients complete their two years of dosing and monitoring scheduled for January 2014."

Anticipated P2 data • Patent • Multiple Sclerosis

Synthetic Biologics announces issuance of U.S. patent adding another layer of protection for the use of oral estriol candidate, Trimesta, for multiple sclerosis (PRNewswire) - "Synthetic Biologics...announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,658,627 entitled, Pregnancy Hormone Combination for Treatment of Autoimmune Diseases, to the Regents of the University of California (UCLA). The patent includes claims to the use of the Company's drug candidate, Trimesta...for the treatment of multiple sclerosis (MS) and other autoimmune diseases."

Patent • Multiple Sclerosis

Synthetic Biologics reports third quarter 2013 financial results and operational update (PRNewswire) - P2, N=64; NCT01466114; "The trial is progressing on schedule, with the last patient visit expected in January 2014, and study results expected during the first half of 2014."

Anticipated P2 data • Anticipated trial completion date • Multiple Sclerosis

Synthetic Biologics reports second quarter 2012 financial results (PRNewswire) - P2, N=164; Enrollment completed for RRMS trial; P2, N=64; Patient enrollment initiated for the study evaluating treatment of cognitive dysfunction in MS; Anticipated sales of $5B annually by 2017

Anticipated sales • Enrollment status • Multiple Sclerosis

Synthetic Biologics reports second quarter 2013 financial results and operational update (PRNewswire) - P2, N=164; NCT00451204; Anticipated data Q1 2014; Anticipated trial completion Jan 2014.

Anticipated P2 data • Anticipated trial completion date • Multiple Sclerosis

The MSDF drug-development pipeline (Multiple Sclerosis Discovery Forum) - "...Synthetic Biologics ended its involvement in the development of estriol as an MS therapy after review of phase 2 trial results"

Discontinued • Multiple Sclerosis

Synthetic Biologics reports results of independent third party evaluations of Trimesta data from investigator-sponsored phase 2 clinical trial for relapsing-remitting multiple sclerosis (PRNewswire) - "Synthetic Biologics...today reported independent third party analysis of...Phase 2 clinical trial that evaluated Trimesta as a treatment for relapsing-remitting multiple sclerosis...Both the clinical and...(MRI) results from the independent analyses did not demonstrate statistically significant differences between the Trimesta plus Copaxone treatment group compared to the Copaxone plus placebo group at either 12 or 24 months...Company has decided to terminate its license and clinical trial agreements relating to Trimesta with the Regents of the University of California."

P2 data • Multiple Sclerosis

A combination trial of estriol plus glatimer acetate in relapsing-remitting multiple sclerosis (AAN 2014) - Presentation time: Wednesday, April 30, 2014 5:35 PM; Abstract #I7-2.002; P2, N=164; NCT00451204; "99.4% had at least one relapse in the preceding 24 months, with 29.4% having at least one enhancing lesion on a single screening MRI. The mean EDSS score was 2.2. The database will be locked and unblinded analyses will be done by the time of presentation. Results from primary and other outcomes will be shown as well as serum estriol levels and safety data."

P2 data • Multiple Sclerosis

Synthetic Biologics: Q2 FY 2014 Results (Synthetic Biologics Press Release) - Anticipated presentation of additional data from P2 trial for MS at ACTRIMS-ECTRIMS (Sep 10-13, 2014)

Anticipated P2 data • Multiple Sclerosis

Synthetic Biologics: ROTH Conference (Synthetic Biologics Press Release) - Anticipated top-line data from P2 trial in RRMS at American Academy of Neurology annual meeting (Apr 29 -  Apr 30, 2014); Anticipated detailed data from P2 trial in RRMS in H2 2014

Anticipated P2 data • Multiple Sclerosis

Synthetic Biologics: Annual ROTH Conference (Synthetic Biologics Press Release) - “Phase 2 relapsing-remitting MS clinical data”; “Data supports potential treatment for cognitive dysfunction: Patients in the Trimesta arm with Paced Auditory Serial Addition Test (PASAT) scores lower than 55 before treatment experienced an 12%, or 6% point, improvement in cognitive scores within 12 months (p<0.05)”; “Improvement from baseline was sustained throughout 24 month study”; “Evidence of improvement of physical disabilities: Expanded Disability Status Scale (EDSS) scores in Trimesta arm significantly improved during 24 month follow-up by at least 0.5 point (p=0.03) compared to the active control arm which experienced no change in EDSS scores: The difference between the two groups showed a positive trend (p=0.25); “The 25 foot walk test showed a significant difference, while the patients in the Trimesta arm were stable during the study, those in active control arm did worse: The difference between the two groups (p=0.02)"

P2 data • Multiple Sclerosis

Synthetic Biologics: Biotech Showcase (Synthetic Biologics Press Release) - Anticipated initiation of pivotal P3 trial in multiple sclerosis in 2016

Anticipated new P3 trial • Multiple Sclerosis

Synthetic Biologics: Marcum LLP MicroCap Conference (Synthetic Biologics Press Release) - "MS: Relapsing-Remitting MS"; "Phase II Results of Trimesta (oral estradiol)"; "Topline results presented at 2014 AAN by Dr. Voskuhl demonstrated: Statistically significant 47% decrease in annualized MS relapse rate at 12 months with Trimesta+Copaxone (p=0.03 / powered for significance level 0.05), 32% decrease in annualized relapse rate at 24 months with Trimesta+Copaxone compared to placebo+Copaxone (p=0.15 / powered for significance level 0.10): Per study protocol, investigators anticipated a 29% decrease in relapse rate at both 12 and 24 months, Clinically significant near-normalization of cognitive scores at 12 months of therapy with Trimesta+Copaxone: Unique neuroprotective effect of oral estriol highly significant to MS community"; "Trimesta+Copaxone was generally well tolerated" 

P2 data • Multiple Sclerosis