Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF), a North American Biopharmaceutical company committed to discovering and developing patient focused psychedelic derived medicines for neurologic and brain disease today announced an updated overview for 2023.
Mr. Philip Young, Chairman and Chief Executive Officer of the Company, stated, “2022 was a productive year for Lobe Sciences. We increased our intellectual property portfolio with several new chemical entities (NCEs) derived from well-known psychedelic compounds, adding two of these, L-130 and L-131, to our development program. We solidified relationships with outstanding research and development teams, who affirmed their support for Lobe by taking an equity stake in the Company. Research collaborations with contract research organizations (CRO) were penned and we began work on a human Phase I Safety and Pharmacokinetics program to ascertain the bioavailability and metabolism of L-130. This trial will be the first of three similar trials that will determine the highest concentration of this NCE without an hullucinagenic effect. International Regulatory filings were completed and accepted in 2022. We expect to begin enrollment in early 2023.”
The Company presented the following timeline for 2023:
- In January 2023, obtain cGMP clinical supplies and transfer these supplies to the international CRO for oral administration to humans in Phase I studies.
- In the first quarter of 2023, commence Phase I Safety and Pharmacokinetics Studies. Data is expected to be available in early in the second quarter of 2023.
- In the first quarter of 2023, commence USFDA required preclinical studies which are expected to be completed by the end of the second quarter of 2023. We have executed a contract with our international preclinical CRO and the active pharmaceutical ingredient (API) export license from US DEA is awaited. Our manufacturing partner has manufactured sufficient quantities of L-130 which will be shipped once required DEA export documents are approved.
- A pre-IND submission package will be filed to confirm that our entire regulatory pathway, which utilizes the 505(b)2 route to approval is appropriate.
- In anticipation of a successful identification of the highest dose having minimal or no hallucinogenic effect, the Company has begun preparation of the Phase II protocol which will utilize that dose. Initial designs for the study are being refined with a second international CRO (iNGEnu).
- In the 2023, the Company anticipates a US IND filing.
L-131
- Synthesis of L-131 has produced sufficient material for preclinical investigation in a pediatric neurological orphan drug application.
- In the first half of 2023, an efficacy evaluation of L-131 utilizing a validated model of the orphan disease application will be initiated following receipt of the DEA export license the preclinical CRO.
- In the second half of 2023, an Orphan Drug Designation filing and a Priority Review Application (a pediatric application of L-131) will be submitted to US FDA following successful completion of the preclinical investigation noted above.
- In the first half of 2023, a pre-IND filing to US FDA will occur to confirm the regulatory strategy being planned for L-131 and its orphan application.
- Preclinical safety and toxicokinetic studies will be initiated following the completion of preclinical pharmacology late in the first half or early in the second half of the year.
Lobe Sciences (OTC:US) expects to file an IND with the USFDA in the second half of the year. In a final comment, Mr. Young said, “Our plans for 2023 are ambitious but doable. By year end, we should have two active INDs, one of which may be designated as an orphan drug and an ongoing Phase II trial assessing L-130 as a therapeutic to treat a refractive neurological disorder. We will release details of each of these trials and the indication being treated as our patents are published.”
Source: https://finance.yahoo.com/news/lobe-sciences-provides-2023-milestones-120000347.html
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