Skye Concentrates Strategy and Clinical Development Focus on Nimacimab Metabolic Program
Skye Bioscience (Nasdaq: SKYE) announced the discontinuation of its SBI-100 Ophthalmic Emulsion (OE) program after it failed to meet the primary endpoint in a Phase 2a trial for glaucoma and ocular hypertension. The study, involving 56 patients, found no statistically significant improvement in intraocular pressure compared to placebo. Consequently, Skye will terminate all R&D related to SBI-100 OE and divert resources to its metabolic program. The company plans to initiate a Phase 2 obesity trial for its CB1 inhibitor, Nimacimab, in Q3 2024 and expects its cash runway to extend into 2027.
- Cash runway extended into 2027.
- Phase 2 obesity trial for Nimacimab expected to start in Q3 2024.
- No early discontinuations due to adverse events in SBI-100 OE trial.
- Nimacimab has potential for sustainable weight loss and better treatments for co-morbid conditions.
- SBI-100 Ophthalmic Emulsion failed to meet primary endpoint in Phase 2a trial.
- Clinical development and spending for SBI-100 OE and related R&D discontinued.
- No statistically significant improvement in intraocular pressure for SBI-100 OE compared to placebo.
Insights
The discontinuation of SBI-100 OE due to its failure to meet the primary endpoint in the Phase 2a trial is a significant development for Skye Bioscience. The redirection of resources to the Nimacimab metabolic program and the extension of the cash runway to 2027 suggest a strategic pivot. Investors should note that the company’s decision to halt development of SBI-100 OE eliminates a potential revenue stream, but the extended cash runway provides a longer operational timeline for the company to develop and possibly bring Nimacimab to market. This strategic shift could mitigate financial risks in the short term while potentially offering higher returns in the long term if Nimacimab proves successful.
However, relying solely on the success of Nimacimab places significant pressure on this program. The clear communication of cash runway extension to 2027 adds positive sentiment, but it's important to monitor upcoming Nimacimab trial milestones closely.
The failure of SBI-100 OE to meet its primary endpoint in the Phase 2a trial indicates that the drug did not sufficiently lower intraocular pressure (IOP) compared to placebo, despite good safety profiles. This outcome is not uncommon in ophthalmology drug development, where achieving statistically significant improvements can be challenging. It's important to recognize the company's pivot to focus on Nimacimab, a peripheral CB1 inhibitor in obesity.
Considering the increasing prevalence of obesity and the need for novel treatments, Nimacimab's unique mechanism could address unmet medical needs. Starting the Phase 2 trial in Q3 2024 and targeting data by 2025 sets a clear timeline for investors to watch. However, it’s important to remain cautious; early-stage development in obesity treatment has a historically high attrition rate.
SBI-100 Ophthalmic Emulsion Phase 2a trial does not achieve target product profile; program discontinued
Phase 2 study of Nimacimab in obesity expected to start in Q3 2024
Cash runway extended into 2027
SAN DIEGO, June 10, 2024 (GLOBE NEWSWIRE) -- Skye Bioscience, Inc. (Nasdaq: SKYE) ("Skye" or the "Company”), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel classes of therapeutic drugs that modulate the endocannabinoid system, announced that its Phase 2a clinical trial of SBI-100 Ophthalmic Emulsion ("OE") in patients with primary open-angle glaucoma ("POAG") or ocular hypertension ("OHT") did not meet its primary endpoint for lowering intraocular pressure (“IOP”). Skye intends to discontinue clinical development and spending related to SBI-100 OE and any R&D associated with SBI-100, including its ophthalmology pipeline, and direct all clinical development resources to its metabolic program, extending its operating runway into 2027. Skye’s Phase 2 obesity clinical trial for its differentiated CB1 inhibitor, Nimacimab, is expected to begin dosing in Q3 2024.
In this Phase 2a double-masked, randomized, placebo-controlled trial of SBI-100 OE, 56 patients with elevated IOP diagnosed with POAG or OHT received dosing of
“The results of this Phase 2a clinical trial of SBI-100 OE unfortunately did not meet our pre-set criteria for continuation and further development of this molecule as an alternative treatment for glaucoma and ocular hypertension. We will continue to evaluate the full data set and intend to publish findings,” said Tu Diep, Skye’s Chief Development Officer. “We thank the patients and investigators who supported our clinical investigation of SBI-100 OE in this study.”
“In the last year we laid the groundwork for our metabolic program with the goals of diversifying our product portfolio’s disease targets and therapeutic mechanisms, while significantly expanding our clinical and business opportunities. With this data outcome from our glaucoma program, we will now focus
About Nimacimab
Nimacimab is a first-in-class humanized monoclonal antibody that acts as a negative allosteric modulator to inhibit CB1 signaling in the periphery. Inhibition of CB1 has shown anti-fibrotic, anti-inflammatory, and metabolic mechanisms of action with potential to address a broad range of diseases with notable unmet medical needs such as obesity, chronic kidney disease, and metabolic dysfunction-associated steatohepatitis (MASH).
About Skye Bioscience
Skye is focused on unlocking the pharmaceutical potential of the endocannabinoid system to treat diseases with metabolic, inflammatory, and fibrotic processes. Backed by specialist life science investors, Skye's strategy leverages biologic targets with substantial human proof of mechanism for the development of first-in-class therapeutics with significant clinical and commercial differentiation. Skye plans to start a Phase 2 clinical trial in obesity in Q3 2024 for Nimacimab, a negative allosteric modulating antibody that peripherally inhibits CB1, comparing monotherapy and combination arms of Nimacimab and a GLP-1R agonist. Clinical development of SBI-100 Ophthalmic Emulsion for glaucoma and ocular hypertension will be discontinued. Please visit: https://www.skyebioscience.com.
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(617) 308-4306
Media Inquiries
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mfitzhugh@lifescicomms.com
(628) 234-3889
FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding our product development, business strategy, the timing of clinical trials and published findings, and expected operating runway. Such statements and other statements in this press release that are not descriptions of historical facts are forward-looking statements that are based on management’s current expectations and assumptions and are subject to risks and uncertainties. If such risks or uncertainties materialize or such assumptions prove incorrect, our business, operating results, financial condition, and stock price could be materially negatively affected. In some cases, forward-looking statements can be identified by terminology including “anticipated,” “plans,” “goal,” “focus,” “aims,” “intends,” “believes,” “can,” “could,” “challenge,” “predictable,” “will,” “would,” “may” or the negative of these terms or other comparable terminology. We operate in a rapidly changing environment, and new risks emerge from time to time. As a result, it is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements the Company may make. Risks and uncertainties that may cause actual results to differ materially include, among others, our capital resources, uncertainty regarding the results of future testing and development efforts and other risks that are described in the Company’s periodic filings with the Securities and Exchange Commission, including in the “Risk Factors” section of Skye’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Except as expressly required by law, Skye disclaims any intent or obligation to update these forward-looking statements.
FAQ
What is the status of Skye Bioscience's SBI-100 Ophthalmic Emulsion program?
When will Skye Bioscience start its Phase 2 obesity trial for Nimacimab?
How long is Skye Bioscience's cash runway extended to?
Did the SBI-100 Ophthalmic Emulsion trial meet its primary endpoint?
What was the primary endpoint of the SBI-100 Ophthalmic Emulsion trial?
