Relmada Therapeutics

Relmada Therapeutics is a publicly owned, clinical-stage pharmaceutical company based in New York City, New York that was founded in 2004 by Najib Babul. It focuses on developing new modified versions of proven drug products together with new chemical entities that could address the treatment of central nervous system (CNS) diseases, opthalmological disorders, major depressive disorder, and chronic pain.

The company has four products in its pipeline, at various stages of development. They include:

• REL-1017
• REL-1021
• REL-1028
• REL-1015

REL-1017 is d-methadone (dextromethadone), a type of N-methyl-D-aspartate (NMDA) receptor antagonist. It is being developed as a possible treatment for MDD, Rett Syndrome, Opthalmological disorders, and mitochondrial diseases & ALS. Relmada began Phase 2 clinical studies of the product for MDD in June 2017. This phase of the study is expected to be completed with top line results available for release in the first half of 2019. As for the treatment of the other illnesses, REL-1017 is still in the pre-clinical stages.

REL-1015, also known as LevoCap ER, is an extended release, abuse deterrent formulation of the opiod analgesic, levorphanol. It is a type of strong opiod that is differentiated from morphine, oxycodone, and others for the management of chronic pain. In clinical studies, levorphanol has demonstrated a broad spectrum of analgesic activity against different types of pain inclluding neuropathic pain, post-surgical pain, and chronic pain. REL-1015 has completed Phase 1 studies and as of December 2018 has no studies ongoing. However, Under the 505(b)2 regulatory pathway, LevoCap could go directly into Phase 3 studies.

REL-1028 (BuTab) is a new oral formulation of the modified release buprenorphine, which is being developed for both chronic pain and opiod dependence indications. Relmada has completed a pre-clinical program to define the pharmacokinetic profile of REL-1028.

REL-1021, also known as MepiGel) is a topical dosage form of local anesthetic mepivacaine for the treatment of painful peripheral neuropathies, such as diabetic neuropathy, postherpetic neuralgia, and HIV-associated neuropathy. The product is currently indicated for infiltration, nerve block, and epidural anesthesia. Relmada has received two FDA Orphan Drug Designations for mepivacaine, one each for the treatment of painful HIV-associated neuropathy and for the management of postherpetic neuralgia. The formulations to be advanced into clinical studies for MepiGel have been selected after evaluations from in vitro and ex vivo studies comparing various topical prototypes. It has also completed toxicology studies.

On October 1, 2013 Relmada Therapeutics completed their series A funding round with $8 million in funding from undisclosed investors.

On May 22, 2014 Relmada Therapeutics completed a venture capital round with $15.1 million in funding from BioAdvance.

On October 5, 2017 Relmada Therpeutics announced a private placement of convertible promissory notes to new and existing investors which provided the company with approximately $6.9 million in gross proceeds.