Gemmus Pharma Announces FDA Acceptance of IND Application for GP1681 - a Novel Host-Based Drug Candidate for Influenza

- Company Awarded Key US Patent -

SAN FRANCISCO--()--Gemmus Pharma, Inc., a privately-held pharmaceutical company developing innovative therapies to treat influenza, announced today that its Investigational New Drug Application (IND) for GP1681, the company’s lead product candidate, has been accepted by the U.S. Food and Drug Administration (FDA) and is now active. Gemmus expects to begin a Phase 1 clinical trial in Q2 2015 to identify suitable doses of GP1681 in healthy adults. “We are very pleased to receive the Safe to Proceed status and we look forward to starting clinical trials for GP1681,” said William Guilford, PhD., President and a co-founder of Gemmus. “We believe that our immune system-based approach to treating influenza should allow for a faster return by patients to normal activity than is possible with existing therapies.”

“We are very pleased to receive the Safe to Proceed status and we look forward to starting clinical trials for GP1681”

In addition to its IND approval, Gemmus has been granted a patent covering the use of GP1681 in combination with antiviral drugs (US patent 8,980,944). “This extension of our patent portfolio further supports our clinical development plans for GP1681,” said William Holstein, Senior Vice President, Business Development of Gemmus.

About GP1681

GP1681 is being developed to alleviate influenza symptoms by reducing, but not eliminating, the viral-induced, exaggerated cytokine response. The potential benefit of treatment with GP1681 is supported by the results in mouse models of influenza. This host-targeted therapy has the potential advantage of being able to treat any influenza virus subtype when flu-symptoms are present without concern for the development of viral resistance.

About Gemmus

Gemmus is a privately held pharmaceutical company focused on the development of innovative products for the treatment of infectious diseases by modulating the host response to the disease. Gemmus was founded in 2007 to develop EP2 and EP4 agonists for the treatment of influenza and in-licensed technology from a major pharmaceutical company. The company has applied for and received an SBIR(NIH) and a QTDP competitive grant. Gemmus is a member of the QB3 network, a San Francisco Bay Area life sciences incubator associated with the University of California – San Francisco (UCSF). The company is currently seeking suitable corporate partners for further clinical development of GP1681 and for expansion into additional viral indications. For more information and corporate background, please visit: www.gemmuspharma.com.

Forward Looking Statements

Statements included in this press release that are not a description of historical facts may be forward looking statements. The inclusion of forward looking statements should not be regarded as a representation by Gemmus that any of its plans will be achieved. Actual results may differ materially from those anticipated or set forth in this press release due to the risks and uncertainties inherent in Gemmus' business including, without limitation, statements about difficulties or delays in developing, obtaining regulatory approval, manufacturing and commercializing its products, unexpected performance or side effects of its products, the scope and validity of its products’ patent protection, competition from other companies and its ability to obtain additional financing to support its operations. All forward looking statements are qualified in their entirety by this statement and Gemmus undertakes no obligation to revise or update this press release to reflect events or circumstances occurring after the date hereof.

Contacts

Gemmus Pharma
William Guilford, 415-978-2151
wguilford@gemmuspharma.com
or
For Gemmus Pharma
Jennifer Larson, 415-725-2017
jlarson@labfive.com

Release Summary

Gemmus Pharma Announces FDA Acceptance of IND Application for GP1681 - a Novel Host-based Drug Candidate for Influenza. The therapy modulates the immune system, avoids issues with viral resistance.

Gemmus Pharma, Inc.