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Effectiveness of VBP15, a dissociative steroidal analogue, on inflammation in a mouse model of arthritis

Award Number: R41AR068816
ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2015
PERIOD OF PERFORMANCE END DATE: 08/31/2017

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Effectiveness of VBP15, a dissociative steroidal analogue, on inflammation in a mouse model of arthritis - ¿ DESCRIPTION (provided by applicant): Glucocorticoids (GC's), such as prednisolone, are used frequently to induce remission and treat rheumatoid arthritis (RA). Despite effectiveness, many GC-mediated detrimental side effects including osteoporosis and muscle atrophy limit long-term chronic treatment of RA patients. In addition, juvenile arthritis patients suffer from th side effect of significant stunting of linear growth. These side effects are believed to be mediated by well-described glucocorticoid response element (GRE)-mediated transcriptional properties (transactivation), whereas efficacy is mediated by transrepression of NFkB pro-inflammatory pathways. ReveraGen BioPharma has identified a lead compound, VBP15, that is a novel dissociative steroid designed to maintain the anti- inflammatory efficacy of traditional steroids through NFkB inhibition and GR translocation, yet has lost GRE- mediated transcriptional activities leading to much less side effects typically associated with traditional glucocorticoid drugs (no osteopenia, growth stunting, or steroid myopathy). Importantly, VBP15 has been shown to reduce inflammatory activity in vivo across multiple murine models of disease. Furthermore, we have demonstrated in a pilot study that VBP15 significantly reduces the severity of disease in the collagen antibody- induced mouse model of arthritis (preliminary data). Thus, VBP15 may represent a safer and more effective alternative to traditional glucocorticoids in the treatment of RA, where treatment of elderly RA patients may show efficacy with loss of osteopenia and steroid-myopathy side effects, and loss of growth stunting side effects important in juvenile RA. The goal of this STTR research is to extend preclinical evaluation of VBP15 with a blinded study of efficacy endpoints in a chronic collagen-induced mouse model of arthritis (CIA) using published recommendations for pre-clinical studies. We hypothesize that VBP15 treatment after disease onset will result in similar anti-inflammatory activity compared to prednisolone but possess a much reduced side effect profile. As VBP15 has already entered Phase 1 clinical trials in adult healthy volunteers, transition to RA trials would likely ensure shortly after the successful completion of the proposed STTR grant.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2018 ( Subtotal = -$21,724 )
2018	2015	REVERAGEN BIOPHARMA, INC.	155 GIBBS ST STE 433	ROCKVILLE	MD	20850	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	1/12/2018	NEW	-$21,724
														Subtotal = -$21,724

Issue Date FY: 2015 ( Subtotal = $225,000 )
2015	2015	VALIDUS BIOPHARMA INC	9700 GREAT SENECA HIGHWAY	ROCKVILLE	MD	20850	MONTGOMERY	USA	Arthritis, Musculoskeletal and Skin Diseases Research	000	1	8/31/2015	NEW	$225,000
														Subtotal = $225,000

Grand Total All Awards = $203,276

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Effectiveness of VBP15, a dissociative steroidal analogue, on inflammation in a mouse model of arthritis

Award Number: R41AR068816

ORGANIZATION: NATIONAL INSTITUTE OF ARTHRITIS & MUSCULOSKELETAL & SKIN DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2015

PERIOD OF PERFORMANCE END DATE: 08/31/2017

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