Silo Pharma Announces Exclusive, Global License for Lead Candidate SPC-15 Targeting PTSD and Stress-Induced Anxiety Disorders
Silo Pharma has secured an exclusive, global license with Columbia University to develop SPC-15, an intranasal treatment for PTSD and stress-induced anxiety disorders. The agreement includes extensive issued and pending IP patent applications. Silo has submitted a pre-IND briefing package to the FDA and is preparing for an IND application to begin human clinical trials. The company plans to use the FDA's 505(b)(2) pathway to expedite development and reduce costs. CEO Eric Weisblum emphasizes that this agreement could potentially increase shareholder value, contingent on FDA approval.
- Exclusive, global license agreement with Columbia University for SPC-15.
- Extensive issued and pending IP patent applications included in the license.
- Submission of pre-IND briefing package and meeting request to the FDA.
- Final steps towards IND application for human clinical trials.
- Utilization of FDA’s 505(b)(2) pathway to shorten clinical timelines and reduce costs.
- Future shareholder value increase is contingent on FDA approval.
Insights
The acquisition of an exclusive, global license for SPC-15 from Columbia University strategically positions Silo Pharma to penetrate the growing market for treatments targeting PTSD and stress-induced anxiety disorders. This move is particularly significant as it includes extensive issued and pending IP patent applications, which strengthens the company's intellectual property portfolio and could potentially deter competition.
Silo's decision to utilize the FDA’s 505(b)(2) pathway for the development of SPC-15 is a shrewd financial maneuver. The 505(b)(2) pathway allows for an expedited review process, leveraging existing data to minimize time and cost associated with drug development. This could potentially lead to faster market entry, providing quicker revenue streams and enhancing shareholder value.
Investors should also note the submission of a pre-IND briefing package and meeting request to the FDA, which indicates that Silo is rapidly advancing toward clinical trials. While still in the developmental phase, the company's proactive steps in securing a licensing deal and preparing for FDA submission are commendable and reflect a focused execution of their strategic plan.
Silo Pharma's SPC-15 candidate, intended for intranasal treatment, addresses significant unmet needs in the field of PTSD and stress-induced anxiety disorders. The non-invasive delivery method of intranasal administration could offer advantages in terms of patient compliance and rapid onset of action, which are critical factors in treating these conditions.
By licensing this candidate from Columbia University, Silo gains access to potentially groundbreaking research and existing intellectual property, which could expedite the development timeline. However, the success of SPC-15 hinges on its performance in clinical trials and investors should be aware of the inherent risks associated with early-stage drug development. The streamlined 505(b)(2) pathway is beneficial, but it does not eliminate the need for rigorous testing and validation.
Furthermore, the submission of a pre-IND briefing package to the FDA suggests that Silo is well-prepared and is likely to meet regulatory requirements efficiently. This could lead to positive outcomes in the initial human trials, though it remains a speculative endeavor until concrete data is available.
Extensive Issued and Pending IP Patent Applications Acquired with License Agreement
SARASOTA, FL, July 08, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced that it has entered into an exclusive, global license agreement with Columbia University to further develop, manufacture, and commercialize its lead drug candidate, SPC-15, an intranasal treatment for stress-induced affective disorders and PTSD.
Silo recently submitted a pre-IND briefing package and meeting request for SPC-15 to the U.S. Food and Drug Administration (FDA) earlier this month. The Company is currently engaged in the final steps required before submission of an IND application to the FDA to begin first-in-human clinical studies. Silo intends to utilize the FDA’s streamlined 505(b)(2) pathway for SPC-15, which would shorten clinical timelines and reduce drug development costs.
“In our opinion, the execution of the exclusive license agreement for our SPC-15 product is a critical step for our Company which we believe could increase shareholder value in the future, subject to FDA approval if and when received,” said Silo CEO Eric Weisblum.
About SPC-15
SPC-15 is a novel serotonin 4 (5-HT4) receptor agonist therapeutic for the treatment of PTSD, anxiety, and other stress-induced affective disorders. SPC-15 is being developed as an intranasal medication. If clinically successful, SPC-15 could qualify for the FDA’s streamlined 505(b)(2) regulatory pathway for drug approval. Silo Pharma is conducting preclinical studies of SPC-15 in collaboration with Columbia University and was granted an exclusive license to further develop, manufacture, and commercialize SPC-15 worldwide.
About Silo Pharma
Silo Pharma Inc. (Nasdaq: SILO) is a developmental stage biopharmaceutical company developing novel therapeutics that address underserved conditions including stress-induced psychiatric disorders, chronic pain conditions, and central nervous system (CNS) diseases. Silo focuses on developing traditional therapies and psychedelic treatments in novel formulations and drug delivery systems. The Company’s lead program, SPC-15, is an intranasal treatment targeting PTSD and stress-induced anxiety disorders. SP-26 is a time-release ketamine-loaded implant for fibromyalgia and chronic pain relief. Silo’s two preclinical programs are SPC-14, an intranasal compound for the treatment of Alzheimer’s disease, and SPU-16, a CNS-homing peptide targeting multiple sclerosis (MS). Silo’s research and development programs are conducted through collaborations with universities and independent laboratories. For more information, visit www.silopharma.com and connect on social media at LinkedIn , X , and Facebook .
Forward-Looking Statements
This news release contains "forward-looking statements" within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential”, and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Contact
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investors@silopharma.com
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