LB Pharma pushes the Biotech bottle introduction window

LB Pharmaceuticals aims to show that what is old can become new again with a main drug candidate who is a modified version of a drug from Sanofi’s old schizophrenia. The strategy resonates with investors, whose interest in LB has enabled the company to increase its IPO and to raise $ 285 million for clinical trials.

The preliminary LB preliminary IPT conditions based in New York, set at the start of this week, aimed to offer more than 16.6 million shares in the range of $ 14 to 16 each, which would have collected around $ 250 million in the midst of prices. LB late Wednesday, LB increased the size of the agreement to 19 million shares at a price of $ 15 each. These actions will be negotiated on the Nasdaq under the “LBRX” stock symbol.

The LB drug candidate, LB-102, is derived from Amisulpride, a medication that emerged from Sanofi laboratories in the 1980s. While this Sanofi drug continued to obtain regulatory approvals in more than 50 countries as treatment of schizophrenia, the pharmaceutical giant did not continue the approval of the FDA because Medication, said LB in its IPO file.

Amisulpride, which Sanofi markets under the Solian brand, is a small oral molecule designed to block the dopamine receiver, in particular the D2 and D3 receptors. The side effects of dopamine receptor antagonists currently available include drowsiness, weight gain, movement disorders and heart rate changes. LB said that its modification of the molecule improves its ability to cross the blood-brain barrier with a minimum impact on the ability of the drug to bind to its targets.

“We believe that the realization of this chemical change allows LB-102 to be dosed of quantities lower than the Amisulpride,” said the company in the file. “In dosage at a lower level, we aim to reduce the side effects common to the Amisulpride. This change in the chemical structure also allows us to differentiate the dosage frequency of LB-102 from that of the Amisulpride. We develop the LB-102 for one dose once a day, unlike the dose twice a day typical of the Amisulpride. ”

In phase 2 tests, LB reported that the three doses of its drug taken once a day have obtained statistically significant results compared to a placebo, measured on a scale used to assess the symptoms of schizophrenia. Adverse events included insomnia, headache, anxiety and agitation. LB said the weight gain was modest and was not associated with a clinically significant signal in metabolic parameters.

LB now plans to carry out a phase 3 clinical trial controlled by placebo of LB-102, evaluating a low dose and a high dose of the study medication. The targeted registration is 400 patients. As with the phase 2 study, the main objective of the test of phase 3 of six weeks is to measure the change of score compared to the basic line according to a scale used to assess the symptoms of schizophrenia. LB plans to start this study in the first quarter of 2026; Preliminary data is expected in the second half of 2027.

The FDA requires two pivotal trials to support the approval of a schizophrenia medication. LB declared in the file that on the basis of the feedback of the FDA and the previous history, the phase 2 study of LB-102, which recruited 359 patients, could be considered as one of the two pivot studies. If this is the case, a positive phase 3 test could allow the company to meet the FDA in early 2028 to discuss regulatory submission. But first, the FDA should agree that phase 2 study is considered a pivotal study. LB thinks that LB-102 could have applications in other indications. A phase 2 test in bipolar depression should start in the first quarter of 2026; Preliminary data is expected in early 2028.

LB initially filed its IPO plans last month. The new capital is sorely necessary. Last spring, a cash tightening sparked restructuring and corporate layoffs. At the end of June, LB said that its cash position was only $ 14.2 million. According to the file, the IPO procedure, LB plans to spend around $ 133 million on phase 3 test of LB-102. Additional 25 million dollars are budgeted to pass the medication through phase 2 tests in bipolar depression. LB also develops an injectable formulation with prolonged action of LB 102, but the deposit does not specify any amount in dollars for these efforts.

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